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 February 16, 2024, Assemblymember Jim Wood introduced Assembly Bill (AB) 3129, which targets healthcare consolidation involving private equity groups and hedge funds. The bill, if enacted, would require private equity...more
In the spirit of the season, we are using our annual "12 Days of California Labor and Employment" blog series to address new California laws and their impact on California employers. On the third day of the holidays, my labor...more
Employers throughout the healthcare industry often experience difficulty hiring physicians due to a shortage of healthcare professionals in the United States. Physicians who hold J-1 visa status often require approval of a...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
Certain COVID-19 emergency declaration blanket waivers are being phased out by the federal government, and health care providers should take steps to determine whether current arrangements are compliant. As background, in...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
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
In our prior bulletin, we discussed the likely lack of civil immunity from Justice Center enforcement actions conferred in other contexts by Executive Order 202.10. However, other Executive Orders provided some relief in the...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
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
The Centers for Medicare & Medicaid Services (CMS) recently issued a 29-page summary of the numerous blanket waivers issued to provide flexibilities to health care providers combating the COVID-19 pandemic....more
On March 30, 2020, in response to the COVID-19 pandemic, Alex Azar, the Secretary of the Department of Health and Human Services (the “Secretary), used his authority under Section 1135 of the Social Security Act to waive...more
On March 30, 2020, the Centers for Medicare and Medicaid Services (CMS) issued new blanket 1135 waivers, making what CMS describes as “sweeping regulatory changes” to the health care system....more
On Saturday, March 28th, the Centers for Medicare & Medicaid Services (“CMS”) announced an expansion of its accelerated and advance payment program for Medicare participating health care providers and suppliers to help...more
On March 25, 2020, the Senate voted 96-0 to approve the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The House is expected to vote on this bill on Friday, March 27....more
On March 20, the Connecticut Office of Health Strategy (OHS) issued new guidance (Guidance) on the process for requesting a certificate of need (CON) waiver for projects related to the COVID-19 response. See our analysis of...more
On March 20, 2020, Georgia Governor Brian Kemp issued an Executive Order "Reducing Regulations to Assist the State's Response to the Spread of COVID-19" (the Order). The purpose of the Order is to reduce "certain restrictions...more
On March 19, 2020, State of Tennessee Governor Bill Lee issued a second executive order, Executive Order No. 15, dealing with a number of measures affecting health care providers....more
In the face of the coronavirus (COVID-19) pandemic, the US president’s National Emergency Declaration, issued on March 13, set in motion several actions required of other agencies to provide the regulatory relief needed to...more
Telehealth Remote Communication Technology - On March 17, 2020, the federal Department of Health and Human Services (HHS) announced that the Office for Civil Rights (OCR) will suspend enforcement activities and waive...more
On March 13, 2020, the Secretary of the U.S. Department of Health And Human Services (HHS) issued a series of waivers pursuant to Section 1135 of the Social Security Act, following President Trump’s declaration that the...more
On March 13, 2020, following President Trump’s declaration of a national emergency due to the COVID-19 (coronavirus) pandemic, the Secretary of Health and Human Services (HHS) issued, among others, the following Emergency...more
In an Advisory Opinion posted earlier this week, the OIG gave the green light to a charitable pediatric clinic’s routine waiver of patient cost-sharing amounts. The OIG’s analysis hinged on several factors that, taken...more