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 Food and Drug Administration (FDA) has issued a final rule, Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations, which allows an exception from the requirement to...more
On August 23, 2023, by a vote of 3-2, the Securities and Exchange Commission (the “SEC”) adopted new final rules and amendments to existing rules under the Investment Advisers Act of 1940, as amended (the “Advisers Act”) with...more
On August 14, 2023, the Office of Management and Budget (OMB) released a pre-publication version of final guidance implementing the Build America, Buy America Act (BABAA).The guidance adds a new Part 184 in 2 C.F.R. and...more
On August 1, 2023, CMS issued its annual Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) Final Rule for FY 2024 (the Final Rule). In the Final Rule, CMS,...more
On February 21, 2023, Treasury and the IRS issued T.D. 9972, finalizing regulations implementing the requirement to e-file certain information and tax returns. These regulations affect filers of partnership returns, corporate...more
On February 15, 2023, the White House Office of Management and Budget (OMB) approved a final rule that would increase certain U.S. Department of State fees for visa services. This is the final step prior to publication of the...more
Included in the defense spending bill signed by President Biden in December 2022 is a section with key provisions for financial institutions that will ease restrictions on hiring candidates with criminal records....more
On January 25, President Biden signed an Executive Order that contemplates increasing the domestic content thresholds and price preferences for domestic goods under the Buy American Act ("BAA," 41 U.S.C. §§ 8301-8305). The...more
Calls for Significant Changes To Federal Domestic Preference Policy, Waivers, and Buy American Eligibility - President Biden signed an executive order (order or EO) on January 25, 2021, to direct more spending of the...more
Caring for Recipients, Protecting the Workforce and Supporting Provider Sustainability - Examine the Immediate Issues and Opportunities Facing Long-Term Care Providers—and Look Ahead at How to Build a Stronger Future—at a...more
Presented below is our summary of significant Internal Revenue Service (IRS) guidance and relevant tax matters for the week of January 14 – 18, 2019. January 15, 2019: The IRS issued final regulations implementing the...more
In a recent decision, the U.S. Court of Appeals for the District of Columbia Circuit determined that the U.S. Environmental Protection Agency (U.S. EPA) wrongly invoked its general waiver authority and set the volumes for...more
On December 7, 2016, the Department of Health and Human Services (HHS), Office of Inspector General (OIG), issued a final rule creating additional “safe harbors” for the Federal Anti-Kickback Statute (42 USC § 1320a-7b(b) et...more
The FAA has issued its long awaited final rule regarding the certification and commercial operation of small unmanned aircraft systems (UAS) in the U.S. National Airspace System. Once effective, the rule will allow certain...more
The Federal Aviation Administration (FAA) has issued its final rule on how businesses may use small unmanned aircraft systems (UAS), often referred to as drones. The rule, which will be commonly known as Part 107, is expected...more
Effective January 1, 2016, the Pension Benefit Guaranty Corporation (PBGC) altered the reportable event rules for defined benefit pension plans. Under new final regulations, the PBGC substantially reduced the reporting...more
Kansas legislators supportive of Medicaid expansion are pulled from committee; Montana’s Medicaid expansion is off to a strong start; and New Mexico sees declines in uncompensated care since ACA implementation....more
On October 29, 2015, the Centers for Medicare and Medicaid Services (CMS) and the Office of Inspector General (OIG) published a final rule regarding the waiver of several federal health care fraud and abuse laws with respect...more
On October 29, 2015, CMS issued its Final Rule setting forth waivers of the application of the physician self-referral law (the Stark law), the Federal anti-kickback statute (AKS), and the civil monetary penalties (CMP) law...more
On October 29th, 2015, the Centers for Medicare and Medicaid Services (“CMS”) issued its final rule (“Final Rule”) for waivers of fraud and abuse laws in the context of the Medicare Shared Savings Program (“Shared Savings...more
Nearly four years after publishing their joint interim final rule with comment period, effective November 2, 2011 (IFC), the OIG and CMS (Agencies) have finalized the waivers of various fraud and abuse laws in the context of...more
Final and Temporary Dividend Equivalent Regulations Issued – Some Good, Some Bad, And Some Ugly: On September 17, 2015, the Internal Revenue Service (“IRS”) released final and temporary regulations under Section 871(m),...more
The Centers for Medicare and Medicaid Services (CMS) and the Office of Inspector General (OIG) of the Department of Health and Human Services just issued a final rule setting forth waivers of specified fraud and abuse laws...more
The Pension Benefit Guaranty Corporation (the PBGC) has adopted final regulations relieving certain sponsors of defined benefit pension plans from the obligation to report certain events that signal an increase in the plan’s...more
Earlier this month, the Pension Benefit Guaranty Corporation (PBGC) issued final regulations on reportable events under ERISA in connection with defined benefit pension plans and their sponsors (the Final Regulations). The...more