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
At the onset of the COVID-19 PHE, CMS was permitted to issue several temporary emergency statutory and regulatory waivers to help providers appropriately respond to the pandemic. On May 1, 2023, the Secretary released a memo...more
With the COVID-19 Public Health Emergency (PHE) ending on May 11th, providers and practitioners must carefully consider the dates when various telehealth waivers and flexibilities end. This requires understanding the...more
The White House recently announced that the COVID-19 national emergency and public health emergency (PHE) declarations will end on May 11, 2023. These declarations have been in place since the beginning of the COVID-19...more
On January 30, 2023, President Biden announced that both the COVID-19 national emergency and the public health emergency (PHE) will end May 11, 2023. This announcement has left many healthcare providers considering how the...more
Maryland health care employers and J-1 physicians who commit to serve the underserved in Maryland and who missed the Dec. 1 J-1 Conrad 30 waiver application deadline are in luck: The Maryland Department of Health (MDH) has...more
While the pandemic is not over, the COVID-19 public health emergency (PHE) is expected to expire soon, which means that a number of operational, safety, and billing standards that were waived at the beginning of the pandemic...more
It has been almost two years since the Centers for Medicare & Medicaid Services (CMS) first issued blanket waivers of certain hospital conditions of participation allowing healthcare systems and hospitals to provide hospital...more
Telehealth has become an integral part of care delivery, particularly in light of the waivers instituted during COVID-19. However, these flexibilities remain in flux and at the same time, government scrutiny and enforcement...more
The novel Coronavirus (“COVID-19”) pandemic has brought about unprecedented applications of certain federal healthcare laws and regulations, including the federal physician self-referral law (the “Stark Law”) and the federal...more
In July of 2016, through 2013 Wisconsin Act 236 (Act 236), many of the regulatory provisions of Wis. Admin. Code DHS 124, Wisconsin’s long-standing hospital regulations, were sunset and replaced with the Medicare Conditions...more
Compliance Today (June 2020) - The burden placed on hospitals during the coronavirus pandemic has spurred regulators to issue waivers and ease restrictions on how healthcare organizations operate. A series of issuances on...more
On May 12, 2020 the Centers for Medicare & Medicaid Services (CMS) issued additional 1135 blanket waivers which are applicable to a wide variety of health care providers. These COVID-19 Emergency Declaration Blanket Waivers...more
On May 11, 2020 the Centers for Medicare and Medicaid Services (CMS) announced additional blanket waivers for hospitals and other facilities in response to the COVID-19 pandemic. According to CMS, the new waivers “provide the...more
On May 8, 2020, the Centers for Medicare & Medicaid Services (CMS) issued new blanket waivers providing flexibilities to care for patients during the COVID-19 public health emergency. Included in this round of blanket waivers...more
As we previously predicted, the Centers for Medicare and Medicaid Services (“CMS”) has continued to issue expansions of the Blanket Waivers applicable during the COVID-19 pandemic. CMS states the reason for issuing these...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
On April 30, 2020, the Centers for Medicare & Medicaid Services (CMS) announced a second round of sweeping regulatory waivers and rule changes in an effort to expand care to Medicare and Medicaid beneficiaries and give...more
On April 21, 2020, the Centers for Medicare and Medicaid Services (CMS) issued explanatory guidance on the scope and application of a series of nationwide Section 1135 waivers of the physician self-referral law (Stark Law)...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
The healthcare real estate industry finds itself in unchartered waters while grappling with the myriad issues created by the COVID-19 pandemic. Landlords are flooded with requests from tenants for rent relief as healthcare...more
In a rapid and remarkable response to COVID-19, The Centers for Medicare & Medicaid Services (CMS) has altered a wide range of coverage and payment rules applicable to hospitals, practitioners and suppliers. In an interim...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
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
In times of emergency, the Secretary of Health and Human Services (the "Secretary") has authority to issue temporary waivers or modifications of certain Medicare, Medicaid, CHIP, and HIPAA requirements. The Centers for...more
On March 30, 2020, the Centers for Medicare and Medicaid Services (“ CMS”) issued Blanket Waivers (the “ Blanket Waivers”) of the Federal Physician Self-Referral Law (the “ Stark Law”) that apply only to financial...more