As summarized in our prior post, on November 23, 2021, the Personnel Management Office, the Internal Revenue Service, the Employee Benefits Security Administration, and the Health and Human Services Department issued interim final rules setting forth directives for implementing a new prescription drug reporting mandate under the 2021 Consolidated Appropriations Act (Public Law 116-260). On June 29, 2022, updated submission instructions describing the reporting process were released. The first deadline to comply with the new rules was December 27, 2022. Under that guidance, it was still unclear whether the relevant departments intended to provide general relief for plans and issuers that made good-faith efforts to comply with the new law.

On December 23, 2022, the Departments of Labor, Health and Human Services, and the Treasury issued FAQs addressing this question directly.Continue Reading A Sigh of Relief: FAQs Confirm Relief for “Good Faith” Effort to Comply with New Prescription Drug Reporting Mandate

In response to the ever-increasing cost of prescription drugs, the 2021 Consolidated Appropriations Act (Public Law 116-260) introduced a new prescription drug reporting mandate intended to make prescription drug pricing more transparent and to assist the Departments of Labor, Treasury, and Health and Human Services with preparing a biannual, publicly available report on prescription drug pricing. The first of these extensive reports is due on December 27, 2022.Continue Reading The Time has Come for New Prescription Drug Reporting Mandate

The Affordable Care Act contains broad provisions requiring health insurers and group health plans to make substantial amounts of information available to the public to facilitate transparency in health care pricing, and several recent Executive Orders have also focused on the availability of health pricing information. In 2020, under the authority of the Affordable Care Act, the Departments of Health and Human Services, Labor, and the Treasury issued transparency in coverage regulations (often referred to as the “TiC Rules”), which require most health plans and health insurance issuers in the group and individual markets (“Plans and Issuers”) to publicly disclose health plan pricing and cost sharing information. The first deadline under the TiC Rules was originally set for January 1, 2022, but was delayed to July 1, 2022 in part due to the enactment of the Consolidated Appropriation Act (which contained additional, and somewhat overlapping, transparency in coverage rules).

Specifically, by July 1, 2022, the TiC rules require that each Plan and Issuer make two “machine readable files” (or “MRFs”) of pricing information available on its public website. Generally speaking, the MRFs that must be available must include (1) the payment rates negotiated between plans or issuers and providers for all covered items and services (the “In-Network File”), and (2) the unique amounts a plan or issuer allowed, as well as the associated billed charged for covered items or services furnished by out-of-network providers during a specified time period (the “Out-of-Network File”). (The deadline for a third file, which must contain pricing information for prescription drugs, was originally January 1, 2022, and has been extended indefinitely pending coordination with similar requirements under the Consolidated Appropriations Act.) Plans and Issuers are not required to disclose information that would violate health privacy laws. The MRFs must be updated monthly and clearly note the date they were last updated. The MRFs must be in a non-proprietary, open-standards format that is “platform independent” and available to the public without restrictions that would impede re-use, such as a JSON file. Microsoft Word, Microsoft Excel, and PDF files are not acceptable because they are proprietary formats.Continue Reading Transparency in Coverage Deadline Looms – Are You Ready?