On June 15, 2022, the U.S. Supreme Court unanimously ruled in favor of “340B” hospitals in a notable statutory interpretation case concerning how the federal Medicare program reimburses hospitals for prescription drugs. The case, which was brought by the American Hospital Association, arises from reimbursement reductions imposed by the Department of Health and Human Services (HHS) in 2018 and 2019 on hospitals participating in the 340B program (which the Court noted are hospitals that “generally serve low-income or rural communities”). In those years, HHS sought to impose reductions in reimbursement due to favorable pricing available to 340B hospitals under that program. The hospitals challenged those reductions based on the process HHS followed when setting the reimbursement rates, claiming that HHS’s failure to conduct a survey of hospitals’ average acquisition costs for the drugs prevented HHS from varying reimbursement rates for this distinct group. Therefore, according to the hospitals, HHS was required to pay them based on the average sales price charged by manufacturers for the drugs.

Continue Reading Supreme Court Decides in Favor of 340B Hospitals Regarding Medicare Reimbursement Methodology

On April 27, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-08 (Advisory Opinion) in which it declined to impose sanctions against a federally qualified health center (Requestor) for an arrangement involving the loaning of smartphones to patients to allow those patients to receive telehealth services from the Requestor. The OIG concluded that although the arrangement would constitute prohibited remuneration under the Federal anti-kickback statute (AKS) and the beneficiary inducement prohibitions of the Civil Monetary Penalties Law (CMP), the limited scope of the arrangement and the safeguards in place did not warrant the imposition of sanctions.

Continue Reading Advisory Opinion 22-08: OIG Declines to Impose Sanctions for Loaning of Smartphones for Receipt of Telehealth Services

The Office of Inspector General (OIG) recently created a new webpage related to telehealth. The purpose of the webpage is to summarize the OIG’s telehealth oversight work to provide a summary of its findings and recommendations that can be used by policymakers and other stakeholders to evaluate potential changes to federal telehealth policies.

Continue Reading OIG Creates New Telehealth Resources Webpage

The federal Office of Inspector General (OIG) recently published a report (OIG Report) as part of a series of analyses of the expansion and utilization of telehealth in response to the COVID-19 public health emergency.  In its report, the OIG concludes that telehealth was “critical for providing services to Medicare beneficiaries during the first year of the pandemic” and that the utilization of telehealth “demonstrates the long-term potential of telehealth to increase access to health care for beneficiaries.” The OIG’s conclusions are notable because they come at a time when policymakers and health care stakeholders are determining whether and how to make permanent certain expansions of telehealth for patients nationwide.

Continue Reading OIG: Telehealth “Critical” to Maintaining Access to Care Amidst COVID-19

On March 16, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-05 (Advisory Opinion) in which it declined to impose sanctions against a medical device manufacturer (Requestor) that proposes to pay certain cost-sharing obligations of clinical trial participants, including Medicare beneficiaries. The OIG concluded that although the proposed arrangement (described below) would constitute prohibited remuneration under the Federal anti-kickback statute (AKS) and the beneficiary inducement prohibitions of the Civil Monetary Penalties Law (CMP), the low-risk nature of the proposed arrangement did not warrant the imposition of sanctions.

Continue Reading Advisory Opinion 22-05: OIG Declines to Impose Sanctions Against Device Manufacturer’s Medicare Cost-Sharing Subsidy in Clinical Trial

In a February 14, 2022, press release, The Joint Commission (Joint Commission) announced that it began surveying affected facilities for compliance with the Centers for Medicare and Medicaid Services (CMS) interim final rule entitled “Omnibus COVID-19 Health Care Staff Vaccination,” published on November 5, 2021, with guidance following on December 28, 2021 (see our previous analysis here and here). Among other things, the rule required eligible staff in affected facilities to be vaccinated against COVID-19. Joint Commission surveying began on January 27, 2022, in states that did not challenge CMS’s interim final rule, and the Joint Commission will begin surveying the remaining states (except Texas) on February 14, 2022. It is not clear when surveys will begin in Texas, as the deadlines for compliance with the interim final rule differ from the other 49 states.
Continue Reading The Joint Commission Announces COVID-19 Vaccine Surveys Have Begun

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

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

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