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
In an informational bulletin, the Centers for Medicare & Medicaid Services (CMS) announced it will further extend waivers for “unwinding” under Section 1902(e)(14)(A) of the Social Security Act until June 30, 2025. The...more
On Tuesday, January 16, 2024, Governor Kathy Hochul released the SFY 2025 New York State Executive Budget (“Executive Budget”). While still subject to legislative approval, the Executive Budget incorporates the recently...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 December 19, 2022, the U.S. Government Accountability Office (GAO) released a report titled, “Medicare: CMS Needs to Address Risks Posed by Provider Enrollment Waivers and Flexibilities” (GAO-23-105494). The report...more
In January 2020, Alex M. Azar, II, then secretary of the U.S. Department of Health and Human Services (HHS), signed a nationwide declaration of a Public Health Emergency (PHE) that would largely shape the response of public...more
In response to the COVID-19 Public Health Emergency (PHE), CMS temporarily waived a significant number of Medicare, Medicaid and Children’s Health Insurance Program (CHIP) requirements and conditions of participation pursuant...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 May 5, 2021, OIG issued guidance on its COVID-19 Administrative Enforcement FAQs page stating that an ambulance provider or supplier waiving or discounting Medicare beneficiary cost-sharing obligations presents a low risk...more
On January 11, 2021, the Centers for Medicare & Medicaid Services (CMS) released a new web portal to more easily permit healthcare providers and other stakeholders to submit requests for specific waivers of certain healthcare...more
On April 3, 2020, the Centers for Medicare & Medicaid Services (CMS) issued guidance to state survey agencies on how to process ambulatory surgical center (ASC) requests to temporarily enroll as hospitals during the COVID-19...more
On March 13, 2020, the President declared the Novel Coronavirus (COVID-19) outbreak in the U.S. a national emergency. The President’s declaration, coupled with Section 1135 (of the Social Security Act) waivers issued by the...more
On a daily basis, if not more frequently, we are astounded by our clients’ efforts to prepare for and respond to the COVID-19 pandemic. As the federal government works to respond to the COVID-19 pandemic, guidance from HHS...more
Following the President’s proclamation on March 13 that the COVID-19 outbreak constitutes a national emergency, Secretary of the Department of Health and Human Services (HHS) Alex Azar issued a Waiver or Modification of...more
The Centers for Medicare & Medicaid Services (CMS) suffered a big loss in court last week. The United States Court of Appeals for the D.C. Circuit upheld a lower court ruling that blocked CMS from implementing one of the...more
On December 12, 2019, CMS approved South Carolina’s proposal for a demonstration project that would add work, or community engagement, requirements as part of the eligibility determinations for the state’s Medicaid plan. ...more
Hospitals operating in regions affected by the recent hurricanes and other natural disasters may be able to obtain temporary regulatory relief. During times of disasters and emergencies, CMS can provide some flexibility...more
As of June 2015, 24 states utilize a traumatic or acquired brain injury waiver,1 as provided under section 1915(c) of the Social Security Act, which are designed to help individuals with traumatic brain injury (TBI) live in...more
On February 9, 2016, the Centers for Medicare and Medicaid Services (CMS) approved Alabama's request for a waiver under Section 1115 of the Social Security Act. The waiver enables the transition of the State's Medicaid...more
On December 30, 2015, CMS approved California’s request for a five-year waiver to extend California’s Section 1115(a) demonstration project, entitled “California Medi-Cal 2020 Demonstration.” According to the CMS approval...more