Health Law Daily Wrap Up, REGULATION TRACKER—Information on pending or recently adopted regulations and regulation amendments, (Jul 27, 2026)
Organizations Mentioned:U.S. Department of Education
By WK Editorial Staff
This Health Law Regulation Tracker includes a Proposed Rules Comment Calendar and a Table of Final Rule Effective Dates.
New proposed rules. On July 23, 2026, CMS issued a proposed rule to revise standards for determining whether an indirect hold harmless arrangement exists for a health care-related tax. The proposed rule is necessary to implement a provision in the ‘‘One Big Beautiful Bill Act,’’ herein referred to as the ‘‘Working Families Tax Cut (WFTC) legislation,’’ which established new indirect hold harmless thresholds for health care-related taxes. Currently, the threshold for a State’s collection of tax revenues is no more than 6 percent of net patient revenue attributable to the assessed permissible class of health care items or services. Effective October 1, 2026, the WFTC legislation generally sets the threshold equal to the applicable percent of net patient revenue attributable to taxes imposed as of July 4, 2025. Effective October 1, 2027, the WFTC legislation also requires a phase down of the hold harmless threshold in expansion States. Apart from establishing the new threshold in regulation and proposing related changes and enhancements to existing processes, we propose to sunset a secondary prong to the indirect hold harmless determination to ensure the thresholds determined as of July 4, 2025, serve as the maximum permissible level. Finally, the rule proposes to add a new permissible class to enhance CMS oversight of health care-related taxes.
On July 23, 2026, the FDA proposed to repeal the color additive regulation that allows for the use of Citrus Red No. 2 for coloring the skins of mature oranges. Based on certification data, it appeared that Citrus Red No. 2 was no longer used for coloring the skins of oranges and has not been certified for use as a color additive in food marketed in the United States since 2020. Because the authorized use of Citrus Red No. 2 appears to have been abandoned, the FDA tentatively concluded that the color additive regulation was outdated and unnecessary.
See the Regulation Tracker for details.
New final rules. On July 20, 2026, the FDA issued a final rule to amend the standard of identity for pasteurized orange juice by lowering the minimum orange juice soluble solids content from 10.5° to 10° Brix and permitting up to 15 percent Citrus reticulata juice or Citrus reticulata hybrid juice, by volume. The FDA’s action is a response to two citizen petitions: one submitted by the Florida Citrus Processors Association Inc. and the Florida Citrus Mutual Inc., and another submitted by the Florida Department of Citrus, the Florida Citrus Mutual, and the Juice Products Association.
On July 23, 2026, HHS rescinded the Guidelines for Eliminating Discrimination and Denial of Services on the Basis of Race, Color, National Origin, Sex, and Handicap in Vocational Education Programs (Guidelines). The Department also made conforming amendments by removing cross-references to the Guidelines in its regulations. The Guidelines were developed and issued by HHS’s predecessor, the Department of Health, Education, and Welfare (HEW), in 1979 in response to litigation concerning HEW’s enforcement of Title VI of the Civil Rights Act of 1964 and a then-existing Federal vocational education program structure. Following the establishment of the U.S. Department of Education (ED) in 1980, administration of Federal vocational education programs, and the associated civil rights compliance framework for those programs detailed in the Guidelines, transferred to ED. HHS does not administer the vocational education program structure contemplated by the Guidelines and does not use the Guidelines as an ongoing compliance mechanism. The continued presence of the Guidelines in the Code of Federal Regulations creates a risk of confusion regarding HHS’s current enforceable nondiscrimination obligations. Rescinding the Guidelines and removing the associated cross-references promotes regulatory clarity without altering any HHS funding recipient’s substantive obligations under Title VI of the Civil Rights Act of 1964, Title IX of the Education Amendments of 1972, or section 504 of the Rehabilitation Act of 1973.
On July 23, 2026, the FDA repealed the color additive regulation that allows for the use of Orange B for coloring the casings or surfaces of frankfurters and sausages. The FDA determined that the authorized use of Orange B has been abandoned, and concluded that the color additive regulation was outdated and unnecessary. Therefore, the FDA is revoking the authorized use in food of Orange B in the color additive regulations.
See the Regulation Tracker for details.
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