On June 2, 2022, the New York State Legislature passed A08472, “An Act to Amend the Public Health Law, in Relation to the Establishment, Incorporation, Construction, or Increase in Capacity of For-Profit Hospice” (“the Act”). The Act prohibits the Public Health and Health Planning Council (PHHPC) of the New York Department of Health (DOH) from approving any new applications for the establishment, incorporation, or construction of a for-profit hospice. Additionally, the bill prohibits PHHPC from approving any increases in capacity to existing for-profit hospices in the state. The two current for-profit hospices will remain approved but cannot expand capacity. The Act will now be presented to the Governor for signature. Once signed by the Governor, the Act will become effective immediately.

Continue Reading New York State Legislature Passes Act Enacting Moratorium on For-Profit Hospices

On May 7, 2022, Connecticut Governor Ned Lamont signed into law the state’s fiscal year 2023 budget (HB5506), which includes the elimination of certain taxes on ambulatory surgical centers (ASCs) in Connecticut. Since October 1, 2015, ASCs have been required to pay a quarterly tax of six percent on their gross receipts (subject

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 February 14, 2022, the Office of Inspector General (OIG) issued Advisory Opinion No. 22-03 (Advisory Opinion) regarding a home health agency’s (Requestor) proposal to pay nurse aide certification tuition costs on behalf of new employees hired to work as certified nurse aides (Proposed Arrangement). The OIG concluded that the Proposed Arrangement would not generate prohibited remuneration under the federal anti-kickback statute (AKS) or the beneficiary inducements civil monetary penalties (CMP).
Continue Reading OIG Issues Favorable Advisory Opinion Regarding Home Health Agency’s Proposal to Pay Tuition Costs for New Employees

On February 9, 2022, the United States Department of Justice (DOJ) announced a $3.8 million settlement with Catholic Medical Center (CMC) of Manchester, New Hampshire. This settlement resolves allegations that CMC violated the False Claims Act (FCA) and federal Anti-Kickback Statute (AKS). The allegations were originally brought in a qui tam lawsuit filed by a physician who is a former employee of CMC.
Continue Reading DOJ Announces $3.8 Million Settlement to Resolve Allegations of False Claims Act and Anti-Kickback Statute Violations

The Food and Drug Administration (FDA) has recently undertaken a number of notable actions with respect to vaccines in response to the ongoing COVID-19 pandemic. Below is an overview of these actions and related COVID-19 vaccine information:

Full Approval of the Moderna COVID-19 Vaccine for 18+

On January 31, 2022, the FDA announced its full approval (licensing) of the Moderna COVID-19 Vaccine for individuals 18 and older. The Moderna vaccine had been administered under an Emergency Use Authorization (EUA) from the FDA since December 18, 2020.  This is the second COVID-19 vaccine to be approved by the FDA following approval of Pfizer-BioNTech’s COVID-19 vaccine on August 23, 2021. Notably, the approved Moderna COVID-19 vaccine will be marketed and known as the ‘Spikevax.’

Continue Reading COVID-19 Vaccine Update – February 2022

I. Biden Administration Requirement for Insurance Companies to Cover Cost of At-Home COVID-19 Tests

On January 10, 2022, the U.S. Department of Health and Human Safety (HHS) announced that the Biden-Harris administration will be requiring insurance companies and group health plans to cover the cost of over-the-counter, at-home COVID-19 tests, so people with private health coverage can get them for free starting January 15, 2022. This new coverage requirement means that most consumers with private health insurance will be able to purchase an at-home COVID-19 test (online or at a pharmacy) and it will either be paid for directly by their health plan or the consumer can submit a claim for reimbursement.

Starting January 15, 2022, insurance companies and health plans will be required to cover eight (8) free over-the-counter at-home tests per covered individual per month, and there will be no limit on the number of tests that are covered if they are ordered or administered by a health care provider following an individualized clinical assessment.

As part of the new requirement, the administration is incentivizing insurers and group health plans to create programs that allow people to get the over-the-counter tests directly through preferred pharmacies, retailers, or other entities with no out-of-pocket costs. Retailers and other entities providing access to consumers for over-the-counter testing should be aware of the requirements. Even if plans and insurers make tests available through preferred pharmacies or retailers, such plans and insurers are still required to reimburse tests purchased by consumers outside of that network, at a rate of up to $12 per individual test (or, if less, the cost of the test)
Continue Reading New COVID-19 At-Home Test Coverage Requirements Increase Need for Heightened Focus on Health Care Entity’s Billing Practices

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

On Monday, November 15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to enforce premarket review requirements for COVID-19 laboratory developed tests (LDTs). This prior policy, which waived premarket review requirements aimed at increasing broad public access to COVID-19 tests, was generally consistent with the FDA’s historical stance allowing laboratories to not seek approval of LDTs. With the policy announced by the Trump administration, laboratories again began offering their tests prior to or without an emergency use authorization (EUA) after the test was validated and a notification was provided to the FDA. While this policy expedited the availability of tests, the FDA contends that the policy also led to some poorly-performing tests being offered prior to FDA review. Notably, this prior policy did not apply to at-home or point of care collection tests, which have always required FDA review.
Continue Reading HHS Again Requires FDA Premarket Review for COVID-19 Tests

On November 4, 2021, the Department of Justice (DOJ) announced the conviction of several South Florida addiction treatment facility operators following a seven-week trial. The initial indictment was filed in September 2020, charging ten defendants for their alleged conduct in committing health care fraud, wire fraud, violations of the Eliminating Kickbacks in Recovery Act (EKRA), the Anti-Kickback Statute, and money laundering. The defendants included the co-owners of two entities providing treatment and therapy for substance use disorder, several other management level individuals, a referring chiropractor, and several marketing employees.
Continue Reading DOJ Focused on Toxicology Testing – EKRA and Anti-Kickback Statute Violations Abound