Long Term Care and Nursing Homes

On November 15, 2023, the U.S Department of Justice (DOJ) announced a $45.6 million consent judgment (Settlement) with six skilled nursing facilities (SNFs), as well as the owner of the SNFs and its management company which managed the SNFs, to resolve alleged violations of the False Claims Act (FCA) tied to medical director arrangements violating the Anti-Kickback Statute (AKS). The Settlement is notable for its inclusion of the owner and the management company in addition to the SNFs, which indicates DOJ’s interest in scrutinizing the actions of individuals and management entities in connection with problematic arrangements under federal fraud and abuse laws.Continue Reading DOJ Settlement Targets Owner and Management Company in Addition to Post-Acute Care Facilities

On June 22, 2023, New York State Public Health Law § 2802-b, added a Health Equity Impact Assessment (HEIA) to the Certificate of Need (CON) process for certain health care facilities. The new requirement comes as part of larger legislative changes to the Public Health Laws passed in 2021. The new HEIA requirement applies to any CON applications submitted on or after June 22, 2023, except there is a partial carve out for Diagnostic and Treatment Centers whose patient population is 50 percent or more Medicaid eligible or uninsured. The Department of Health also issued regulations on June 29, 2023 (10 NYCRR 400.26). The purpose of the HEIA is to understand the health equity impact on a specific project, the impact it may have on medically underserved groups and to ensure community input and assessment are considered. The Department of Health has expressed that their vision is “to have health equity considerations meaningfully impact the planning and execution of health care facility projects.” (NYSDOH, Health Equity Impact Assessment, Webinar Series: Program Documents, September 14, 2023.)Continue Reading New York Implements Health Equity Impact Assessment as New Requirement for Certificate of Need Process

On April 14, 2023, the Attorneys General of 18 different states sent a letter to Health and Human Services (HHS) Secretary Xavier Becerra and Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure in support of a proposed rule that would require the disclosure of certain ownership information regarding Medicare skilled nursing facilities (SNFs) and Medicaid nursing facilities (collectively “Nursing Facilities”), particularly from private equity investors and real estate investment trusts (the “Proposed Rule”).Continue Reading Eighteen States’ Attorneys General Send Letter to CMS in Support of Proposed Rule Requiring Disclosure of Certain Nursing Home and SNF Ownership Information 

On December 27, 2022, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule (Proposed Rule) which proposes certain policy and technical changes to Medicare regulations, including a notable change to the current standard under the “60-Day Rule” for identifying a Medicare overpayment. Specifically, CMS indicated that it is proposing to (i) “adopt by reference” the federal False Claims Act’s (FCA) definitions of “knowing” and “knowingly” as governing when an overpayment is identified, and (ii) eliminate the “reasonable diligence” standard that has been in place, but subject to challenges, for a number of years.Continue Reading No More Reasonable Diligence? CMS Proposes to Change Standard for Identifying Medicare Overpayments to Align with False Claims Act

On August 18, 2022, New Jersey Governor Phil Murphy signed S-315, “An Act concerning changes in control of health care entities” (the Act). The Act implements employment protection for healthcare workers when certain licensed health care facilities, staffing registries, and home care services in New Jersey undergo a change in ownership. The Act first requires that former health care entity employers provide the successor health care entity with information pertaining to employees (i.e., employee names, addresses, dates of hire, phone numbers, wage rates, employment classifications) not less than thirty days before a change in control. The Act also requires former health care entity owners to inform eligible employees of the rights provided by the Act and to post a notice of their rights under the Act in a conspicuous location.Continue Reading New Jersey Governor Signs Act Concerning Changes in Control of Health Care Entities

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 response to the COVID-19 public health emergency CMS previously enacted extensive temporary COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers. However, the Centers for Medicare and Medicaid Services (CMS) have now determined that various regulatory requirements must be restored in order to protect the health and safety of residents in long-term care facilities.Continue Reading NOTICE TO PROVIDERS: CMS Phasing Out Certain COVID-19 Regulatory Waivers in Long-Term Care Facilities, Hospices, and ESRD Facilities

On December 2, 2021, the Centers for Medicare and Medicaid Services (CMS) issued a memorandum to state survey agencies indicating that it will not enforce its Interim Final Rule (the “Rule”) regarding health care worker vaccinations while there are court-ordered injunctions against the Rule in place.
Continue Reading CMS Issues Memorandum Stating It Will Not Enforce Its COVID-19 Vaccine Mandate While There are Court-Ordered Injunctions in Place

On November 12, 2021, the Centers for Medicare & Medicaid Services (CMS) issued finalized guidance (“Guidance”) clarifying that hospitals can share space, services, or personnel with another hospital or health care provider so long as they demonstrate independent compliance with the Medicare Conditions of Participation (CoPs). This Guidance, which finalizes the prior draft guidance issued on May 3, 2019, explains how CMS and state agency surveyors will evaluate a hospital’s space sharing or contracted staff arrangements when assessing the hospital’s compliance with the Medicare CoPs.  The Guidance took effect immediately upon publication on November 12, 2021.

As relayed by CMS, hospitals have increasingly co-located with other hospitals or other healthcare entities as they seek efficiencies and develop different delivery systems of care. Co-location occurs when two Medicare certified hospitals or a Medicare certified hospital and another healthcare entity are located on the same campus or in the same building and share space, staff, or services.
Continue Reading CMS Finalizes Guidance on Hospital Co-Location

To ensure the continued availability of health care workers, on November 12, 2021, the Massachusetts Department of Public Health (DPH) issued Order 2021-13 (COVID-19 Public Health Emergency Order No. 2021-13), extending licensure reciprocity for certain out-of-state providers to provide services (in person or via telemedicine) to patients in Massachusetts. Order 2021-13 extends prior DPH orders which authorized issuance of temporary licenses for certain health care providers and renewal or reactivation of certain temporary licenses.
Continue Reading Massachusetts DPH Issues Two Orders To Ensure Continued Availability of Health Care Provider Workforce

On November 4, 2021, the Centers for Medicare & Medicaid Services (CMS) issued heavily anticipated emergency regulations requiring COVID-19 vaccination of eligible staff at health care facilities that participate in the Medicare and Medicaid programs. CMS issued an Interim Final Rule (IFR) in response to the COVID-19 “Path out of the Pandemic” Action Plan announced by President Biden on September 9, 2021, that per CMS is intended to protect the health and safety of residents, patients and staff at health care facilities. See our previous analysis of the Plan here.

Below please find key takeaways regarding the new COVID-19 vaccination requirements for health care facilities and staff:
Continue Reading CMS Issues Emergency Regulation Requiring COVID-19 Vaccination for Health Care Facility Workers