On September 26, 2022, the United States Department of Justice (DOJ) announced a $900 million settlement with pharmaceutical company Biogen Inc., which arose from alleged violations of the federal False Claims Act (FCA) and Anti-Kickback Statute (AKS) tied to payments from the company to physicians, which were allegedly intended to induce prescription of Biogen’s drugs. The matter initiated as a qui tam whistleblower complaint filed by an employee under the FCA.

Continue Reading DOJ Announces $900 Million Settlement Tied to Speaker Bureau Payments to Physicians

Below is an excerpt of a contributed article co-authored with Robinson+Cole Business Litigation Group lawyer Ben Daniels published in Physicians Practice on September 16, 2022.

On July 25, 2022, the U.S. Court of Appeals for the Second Circuit rejected an appeal brought by Pfizer, Inc. in a case that examines whether a “corrupt” intent is

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

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