In a notice published on April 7, 2022, the Health Resources and Services Administration (HRSA), the division of HHS that manages the distribution and oversight of CARES Act Provider Relief Funds (PRFs), requested comments from stakeholders on proposed changes to its Information Collection Request (ICR) Form that it will be submitting to the Office of Management and Budget (OMB).

The approved ICR uses an OMB form that is set to expire on January 1, 2023, so HRSA is requesting comments before submitting revisions to OMB. This is the first opportunity for providers who were subject to the first two PRF reporting periods (Period 1 and Period 2) to comment on the reporting program and provide feedback on requirements related to those reports. In addition to revising the PRF reporting form, HRSA is looking to add reporting for the American Rescue Plan (ARP) rural provider program to the ICR.

The ARP rural provider program was put in place by Congress to provide payments to providers and suppliers who served rural Medicaid, CHIP and Medicare beneficiaries from January 1, 2019 through September 30, 2020. The ARP Rural plan is distinct from the PRF, but it has similar reporting requirements and uses the PRF reporting portal for applications.
Continue Reading HRSA asks for comment on provider relief fund and ARP rural reporting requirements

The Department of Health and Human Services (HHS), through its Health Resources and Services Administration (HRSA) office, is taking action to recoup CARES Act funding from health care providers who received relief funding but did not meet the reporting requirements set by HRSA.

To receive COVID-19 relief funding from HRSA pursuant to the CARES Act, providers had to attest to compliance with the terms and conditions promulgated by HRSA. Recipients of the funds must agree to the terms and conditions specific to the Phase in which they received funding distribution. Those terms and conditions evolved over time, with different reporting periods for each wave of funding. Under all waves, failure to report to HRSA regarding the use or allocation of received funds constitutes noncompliance with HRSA’s terms and conditions and requires repayment of the funds.

Providers who completed reporting, but reported unused funds, will have 30 days from the end of their specific reporting deadline to return all unused funds.
Continue Reading Provider relief fund reporting: HRSA to recoup funds from providers who didn’t meet deadlines

On August 1, 2021, the Senate released the legislative text of the bipartisan infrastructure bill, the “Infrastructure Investment and Jobs Act,” H.R. 3684.  The Senate is expected to vote this week, before a month-long recess beginning on August 9, 2021.  The 2,702 page legislation contains several relevant health care-related provisions, including a delay of the implementation of the rule eliminating the Anti-Kickback Statute (“AKS”) safe harbor protection for Medicare Part D rebates.

Rebate for Discarded Amounts of Medicare Part B Single-Dose Container or Single-Use Package Drugs

First, the legislation requires manufacturers of single-dose container or single-use package drugs payable under Medicare Part B to provide a rebate to the government for any discarded portion of that drug.  The rebates will be charged each quarter, beginning with the first quarter of 2023, and must be paid in regular intervals, as determined appropriate by the Secretary of the U.S. Department of Health and Human Services (“HHS”).  The legislation provides that, in order to enforce this provision, HHS will conduct periodic audits of both drug manufacturers and providers who submit claims.  For violations of this provision, HHS will impose Civil Monetary Penalties in amounts equal to the sum of the amount that the manufacturer would have paid and twenty-five percent of such amount.Continue Reading Health Care Provisions in the Infrastructure Investment and Jobs Act

On July 1, 2021, the U.S. Department of Health and Human Services (“HHS”), through the Health Resources and Services Administration (“HRSA”) notified recipients of Provider Relief Fund (“PRF”) payments via e-mail that the PRF Reporting Portal is now open for providers who are required to report on the use of funds in Reporting Period 1