The End of COVID Waivers and Exceptions: What Now?
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
NGE On Demand: COVID-19 and IP Waiver for Patent Protection with Kevin O'Connor and Olivia Luk Bedi
Prohibitions on Use of Chinese Telecommunications Equipment and Services, Complying with the NDAA
COVID-19: Where are we now?
Compliance Perspectives: Changes to the Physician Self-Referral and Anti-Kickback Rules
Value-based health care: fraud & abuse laws
What patients misunderstand about their right of informed consent
Bill on Bankruptcy: ResCap Report, a Bargain at $83 Million
The U.S. Department of Transportation Federal Highway Administration (FHWA) on March 7, 2024, announced a proposed rule that would discontinue its longstanding Buy America waiver for manufactured products used in FHWA-funded...more
This webinar will equip healthcare providers working via telemedicine with the invaluable information they'll need to know for a smooth transition toward compliance with the proposed rule changes. Join attorney Paul...more
As we previously covered, in March 2023, the Drug Enforcement Agency (DEA) announced a proposed rule on prescribing controlled substances via telehealth, aimed at addressing the “telehealth cliff” that was expected to occur...more
On January 11, 2023, the Consumer Financial Protection Bureau (CFPB) proposed a new rule to apparently shed light on the dark corners of the financial industry. The proposed rule would create a public registry of the fine...more
The Food and Drug Administration (FDA) recently issued a proposed rule that would extensively modify and modernize its current regulations governing the protection of human subjects and Institutional Review Boards (IRBs).1 If...more
On June 1, 2022, the U.S. Environmental Protection Agency (EPA) issued a proposed rule that would modify its requirements for water quality certification under Clean Water Act (CWA) Section 401 (the “Proposed Rule”). The...more
On July 7, 2022, the Centers for Medicare and Medicaid Services (CMS) released its proposed 2023 Medicare Physician Fee Schedule (PFS) rule. The rule, if enacted as proposed, will: Create three new permanent telehealth...more
On April 29, 2022, CMS issued its final rule for Medicare Advantage (MA) and Part D plans with updates including reduced out-of-pocket costs for prescription drugs and improved consumer protections. CMS published the final...more
I noted in yesterday’s post about the NHTSA proposal to withdraw the SAFE I Rule that EPA was expected to follow the NHTSA action by restoring the Clean Air Act Section 209 waiver for California’s Advanced Clean Car program....more
Last week, the National Highway Traffic Safety Administration proposed to withdraw Part I of the Trump Administration’s SAFE Rule, in which EPA had concluded that California’s regulation of motor vehicle GHG emissions was...more
As noted in our March 31, 2020 blog article, “Strategies in Responding to COVID-19: Expanding Scope of Practice to Increase Patient Access to Healthcare” and in our May 8, 2020 blog article, “COVID-19: Medical Liability for...more
On August 4, 2020, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule to update its payment policies under the Medicare Physician Fee Schedule (PFS) for calendar year 2021. The proposed rule was...more
As healthcare moves increasingly from fee-for-service model to one focused on outcomes and value-based payments, the traditional fraud and abuse laws, such as the Anti-Kickback Statute and the Stark Law, pose obstacles to...more
On November 15, 2018, the Food and Drug Administration (FDA) published a Proposed Rule to amend its regulations to allow waiver or alteration of informed consent requirements in certain FDA-regulated clinical investigations...more
The Centers for Medicare & Medicaid Services (“CMS”) recently proposed a major redesign of its Medicare Shared Savings Program (“MSSP”) under a new plan it calls “Pathways to Success.” In this Part II of the two-part series...more
The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule on July 25, 2016, entitled, Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and...more