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
On Friday, August 4th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food,...more
This is the latest in a series of articles discussing selected updates to the Department of Consumer Affairs’ (DCA) waivers issued in response to Governor Newsom’s March 30, 2020 Executive Order N-39-20, which authorized the...more
The Department of Consumer Affairs (DCA) continues to issue and extend waivers under Governor Newsom’s March 30, 2020 Executive Order, which authorized the DCA to temporarily modify licensing and staffing requirements for...more
Last week CMS issued a new round of regulatory waivers and rule changes in response to the COVID-19 public health emergency, including its Interim Final Rule with comment period, CMS-5531-IFC. The key changes relax certain...more
This content was last updated as of Thursday, April 24 at 12:00 p.m. CST- The Centers for Medicare & Medicaid Services (CMS) continues its issuance of Section 1135 waivers, waiving or modifying certain Medicare, Medicaid,...more
During the week of April 13, 2020, several new regulatory waivers were issued. Updates were also made to a variety of previously issued waivers addressing the COVID-19 (coronavirus) public health emergency....more
The Centers for Medicare & Medicaid Services (CMS) continues its issuance of Section 1135 waivers, waiving or modifying certain Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements to ensure that...more
In response to the federal and state declarations of public health emergencies surrounding the COVID-19 pandemic, the California State Board of Pharmacy has issued the following waivers to California Board of Pharmacy...more
On March 24, 2020, the Massachusetts Department of Public Health (DPH) issued a Public Health Advisory which directs individuals over the aged 70 and those with underlying health conditions to stay at home, and requires all...more
On March 30, 2020, CMS issued numerous additional blanket waivers to give providers greater flexibility in responding to COVID-19. (See https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-waivers.pdf)....more
In the face of these unprecedented times brought on by the COVID-19 pandemic, pharmacies are grappling to find ways to protect patients and employees. In response, state officials and boards of pharmacies have reacted in a...more
The Ohio Board of Pharmacy (OBOP) is actively working to modify its rules or formulate temporary guidance and procedures to help combat the spread of COVID-19 (coronavirus) and aid in the delivery of pharmacy care to impacted...more
On Monday, March 9, 2020, the Centers for Medicare and Medicaid (CMS) released information on permissible flexibilities and obligations that are in effect during a disaster and emergency resulting from COVID-19....more
Last year, the Oklahoma legislature joined a growing number of states in taking direct aim at the opioid crisis by enacting legislation designed to combat the forgery of paper prescriptions. More than a year and a half after...more
On January 23, 2019, Massachusetts Governor Charlie Baker revealed his fiscal year 2020 budget for the Commonwealth of $42.7 billion. While the budget contains a number of new initiatives, one new initiative is particularly...more
In the fourth episode of our series on the national opioid crisis, Ruth Granfors and Tracy Lawless discuss how opioid treatment is reimbursed under Medicaid and other public programs...more
Just in time for the New Year, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued final regulations (Final Regulations) that revised two existing Anti-Kickback Statute safe...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
This Week: Bipartisan Senate Letter Questions HHS and CMS on Details of State ACA Waivers...OMB Is Reviewing Final Medicaid-Covered Outpatient Drug Rule...Delaware Forgoes Transition to State-Based Exchange....more
Last week, the HHS OIG released a proposed rule published in the October 3 Federal Register that would add new safe harbors to the Anti-Kickback Statute and expand the list of conduct exempt from civil monetary penalties...more
On October 2, 2014, the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) published a proposed rule containing revisions to both the Anti-Kickback Statute (AKS) safe harbors and the civil...more
After receiving many comments on its Draft Call Letter, CMS published its Contract Year 2014 Final Call Letter on April 1, 2013. The Final Call Letter addresses a wide variety of issues that will affect all parties involved...more