Government Enforcement

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

In a per curiam decision issued January 13, 2022, the U.S. Supreme Court upheld the federal health care worker vaccine mandate rule, finding that the Department of Health & Human Services (HHS) Centers for Medicare & Medicaid Services was authorized by law to issue the rule.  See our previous analyses of the rule and subsequent litigation here and here for more background information on the stakes of this case.
Continue Reading U.S. Supreme Court Upholds Health Care Worker Vaccine Mandate

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 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 September 9, 2021 President Biden announced a COVID-19 Action Plan entitled “Path out of the Pandemic” (the “Plan”) which comprises a six-pronged national strategy aimed at combatting COVID-19. The Plan includes a number of important provisions related to health care, including implementation of COVID-19 vaccine requirements and an expansion of resources available for treatment of COVID-19. The Plan signals significant changes upcoming for health care organizations, their employees, and their patients.

The following summary addresses certain parts of the Plan with specific implications for health care, but please continue to check R+C blogs and legal updates for follow-up analysis of the specific guidance and rules that are released in furtherance of the Plan.
Continue Reading Biden COVID-19 Action Plan Expands Vaccine Mandates, Testing, and Treatment to Combat Spread of Virus

On August 19, 2021, Connecticut Governor Ned Lamont issued Executive Order No. 13C (the “Order”) to expand access to COVID-19 vaccination information for patients and providers (and school nurses) as public health authorities continue to promote vaccination efforts, implement recommendations for vaccine booster shots, and as schools adopt COVID-19 control measures for returning students and

On July 7, 2021, Connecticut Governor Ned Lamont signed into law Public Act 21-129 entitled “An Act Concerning Hospital Billing and Collection Efforts By Hospitals And Collection Agencies” (“the Act”). The Act expands the types of entities to which billing and collection restrictions apply, places further limitations on collection efforts by such entities, and makes several changes to Connecticut’s existing laws concerning facility fees.
Continue Reading Connecticut Governor Signs Bill Limiting Hospital Billing and Collection Efforts and Revising Connecticut’s Facility Fee Laws

On June 16, and then on July 6, 2021, Connecticut Governor Ned Lamont signed into law a pair of bills that together address privacy and cybersecurity in the state. As cybersecurity risks continue to pose a significant threat to businesses and the integrity of private information, Connecticut joins other states in revisiting its data breach reporting laws to strengthen reporting requirements, and offer protection to businesses that have been the subject of a breach despite implementing cybersecurity safeguards from certain damages in resulting litigation.

Public Act 21-59 “An Act Concerning Data Privacy Breaches” (PA 21-59) modifies Connecticut law addressing data privacy breaches to expand the types of information that are protected in the event of a breach, to shorten the timeframe for reporting a breach, to clarify applicability of the law to anyone who owns, licenses, or maintains computerized data that includes “personal information,” and to create an exception for entities that report breaches in accordance with HIPAA. Public Act 21-119 “An Act Incentivizing the Adoption of Cybersecurity Standards for Businesses” (PA 21-119) correspondingly establishes statutory protection from punitive damages in a tort action alleging that inadequate cybersecurity controls resulted in a data breach against an entity covered by the law if the entity maintained a written cybersecurity program conforming to industry standards (as set forth in PA 21-119).

Both laws take effect October 1, 2021.
Continue Reading Connecticut Enacts Legislation to Incentivize Adoption of Cybersecurity Safeguards and Expand Breach Reporting Obligations