The Regulator

1 milligram per gram: that is the line the Drug Enforcement Administration (DEA) proposes to draw through the kratom-derived opioid market, in a notice published October 14. DEA says it intends to place 7-hydroxymitragynine (7-OH) and mitragynine pseudoindoxyl in Schedule I, the most restricted tier, whenever either one, or the two combined, exceeds 1 milligram per gram of a solid or 1 milligram per milliliter of a liquid, or whenever the ratio of mitragynine to the substance falls below 100. The notice does not schedule mitragynine itself, and says the threshold would let some products stay on the market. It follows an October 8 letter from the Assistant Secretary for Health recommending the new cutoff, and DEA is withdrawing its July 2026 notice of intent on 7-OH, which used a different threshold. The temporary order will be published on or after November 13, takes effect on publication, and lasts two years with a possible one-year extension. DEA says notice-and-comment does not apply and that the order does not override stricter state laws. A companion notice covers two more compounds, MGM-15 and MGM-16, which DEA says run about 50 and 240 times morphine’s pain-relief potency in animal studies. Who it hits: any maker, distributor, importer or retailer, including smoke shops, gas stations and online vendors, handling products above the line. Confidence: High on the text and dates; Low on how many products on shelves today clear the threshold. Sources: Federal Register, DEA notice of intent on 7-hydroxymitragynine and mitragynine pseudoindoxyl, Federal Register, DEA notice of intent on MGM-15 and MGM-16.

Federal Medicaid and Children’s Health Insurance Program (CHIP) money for “sex-rejecting procedures” for minors stopped October 13. The Centers for Medicare & Medicaid Services (CMS) final rule, published August 13, took effect that day. State Medicaid plans may not pay for the procedures for children under 18, CHIP plans for children under 19, and federal matching funds may not be used for them. States may keep claiming federal funds for up to six months for cross-sex hormone therapy for beneficiaries already receiving it, which runs to April 13, 2027; the grace period does not cover puberty blockers or surgery or anyone who starts after October 13. Per reporting by New York Attorney General Letitia James’s office, 21 attorneys general and Pennsylvania’s governor have sued, arguing CMS exceeded its authority; the court filings are not yet reviewed here, so we cannot report the case status. This is a continuing story from our August 12 coverage. Confidence: High on the effective date and the transition; Low on litigation status. Sources: Federal Register, Prohibition on Federal Medicaid and CHIP Funding for Sex-Rejecting Procedures Furnished to Children, supplemental: New York Attorney General press release.

HHS Secretary Robert F. Kennedy, Jr. handed the CMS Administrator the power to exclude providers from federal health programs. A delegation notice in the October 14 Federal Register moves the authorities under section 1128(b) of the Social Security Act, the “permissive” exclusions that let the government bar a provider without a conviction, to the CMS Administrator, effective immediately. It leaves out the power to hold hearings and to write regulations, and it keeps the earlier delegation to the HHS Inspector General in place. The notice does not say how CMS will use the power or whether the Inspector General’s workload changes. Watch for the first CMS-initiated exclusion and any change to who sends the notice letters. Confidence: High on the text; Low on practical effect. Source: Federal Register, HHS Statement of Delegation of Authority.

CMS announced Rural Health Transformation Program money for two more states on October 13: more than $177 million for Nebraska and more than $2.3 million for Missouri. Nebraska’s release says its recruitment awards have produced contracts with providers in 51 counties, remote-monitoring technology (68 devices) in 45 facilities, and more than 200 community health worker positions. Missouri’s money is $1.46 million for a cost-shared childcare program for rural health workers and $879,000 to start the state’s first certified nurse midwife training program. Both releases describe the amounts as part of larger fiscal year 2026 awards without stating the totals, so the share of each state’s award is not confirmed here. The program is a $50 billion national fund. Confidence: High on the announced figures. Sources: CMS press release, Nebraska, CMS press release, Missouri.

The National Institutes of Health (NIH) proposes a Chief Artificial Intelligence Officer and a new home for its dietary supplements office; comments are due October 28. The notice would create an Office of the NIH Chief Artificial Intelligence Officer inside the Division of Program Coordination, Planning, and Strategic Initiatives and move the Office of Dietary Supplements under the Office of Nutrition Research in the same division. Comments go to DPCPSIreorgcomments@nih.gov. The notice carries no dollar figure. Confidence: High. Source: Federal Register, NIH Notice of Proposed Reorganization.