The Regulator

CMS finalizes a 2027 dialysis payment rate of $297.52 per treatment, up $15.81, for about 7,600 facilities and $7.0 billion in Medicare spending. The Centers for Medicare & Medicaid Services (CMS) rule for the End-Stage Renal Disease (ESRD) Prospective Payment System was published in the Federal Register today and takes effect January 1, 2027. Of the $15.81 increase, $12.85 folds phosphate binders (drugs that control blood phosphorus) into the base rate, and CMS projects total payments to rise about 2.7%. The low-volume adjustment threshold doubles from 4,000 to 8,000 treatments with six tiers instead of two, a budget-neutral change that trims the base rate by about 1.1%, roughly $3. The home and self-dialysis training add-on rises from $95.60 to $138.00. Who it hits: dialysis chains and independent clinics, with small and rural facilities gaining from the low-volume change at the expense of everyone else’s base rate. So what: the low-volume attestation deadline is December 31, 2026, and outlier thresholds for adult patients jump from $14.80 to $90.60 because CMS expects new high-cost drugs. Confidence: High, from CMS’s own fact sheet and the Federal Register abstract. Sources: CMS fact sheet, CMS-1846-F, Federal Register final rule.

HHS tells pharmacies it will not enforce against compounding six unapproved peptides, including BPC-157, while FDA writes a formal list. An enforcement discretion policy, published in the Federal Register today, covers BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500, reportedly for state-licensed pharmacies, federal facilities and licensed physicians. Trade reporting says the policy requires patient-specific prescriptions, traceable ingredients, quality testing and safety reporting, and that HHS says it does not make the peptides approved or establish that they are safe or effective. It follows a July advisory committee vote on the 503A bulks list (the list of ingredients pharmacies may compound), and the Partnership for Safe Medicines has petitioned FDA to block compounding. Who it hits: compounding pharmacies, wellness clinics and patients buying peptides. So what: written comments are reportedly due two weeks after publication, which by our count is November 13, and states may not follow the federal relaxation. Confidence: High that the policy was published; Med on the conditions and comment date, which come from trade reporting because we could not open the Federal Register text. Sources: Federal Register notice. Supplemental: AJMC summary.

UPDATE: the CDC’s Ebola flight attestation now has an end date of December 18, 2026, and covers aircraft crew. We reported October 28 that the order stated no end date. The amended order, published in the Federal Register today, says it runs through December 18, 2026 and may be changed or rescinded sooner. CDC’s page says it clarifies that the requirement applies to everyone on any aircraft, including crew on passenger and cargo flights and those positioned without operating. The requirement still takes effect at 11:59 p.m. Eastern on November 3 for flights departing a foreign country for the United States. Who it hits: airlines and crew scheduling. So what: carriers get a bounded compliance window, though it can be extended by a new order. Confidence: High. Sources: Federal Register amended order, CDC attestation order page.

CDC opens nominations for its vaccine advisory committee, due December 31. The Federal Register notice published today seeks nominees for the Advisory Committee on Immunization Practices (ACIP), which can have up to 19 members with scientific, clinical and public health expertise, including consumer or community representatives. Nominations received after December 31, 2026 will not be considered for the current membership cycle. Who it hits: insurers and states that tie vaccine coverage to ACIP recommendations, and the clinicians and groups that might nominate members. So what: ACIP votes drive coverage requirements, so the roster set this cycle shapes which vaccines plans must pay for. The notice gives no meeting date. Confidence: High. Source: Federal Register notice.

Texas: CMS announces $87 million for 129 rural providers, and California gets more than $233 million, from the $50 billion Rural Health Transformation Program. The October 29 CMS releases say the Texas money, under a “Rural Texas Strong” initiative, funds chronic disease prevention, recruiting physicians and emergency medical personnel, and replacing aging equipment. California’s $233.6 million targets regional care networks, telehealth, maternal care partnerships with midwives, doulas and community health workers, workforce training and technology upgrades. Both are fiscal year 2026 money from the program funded by the Working Families Tax Cuts Act. Who it hits: rural hospitals, clinics and emergency services in both states. So what: the Texas release counts 129 providers, while one lawmaker’s statement cites 68 rural hospital districts and authorities, so check which entities receive money before assuming a hospital is covered. Confidence: High on amounts; Med on recipient counts. Sources: CMS release on Texas, CMS release on California.

Six dialysis centers agree to pay about $2 million over Provider Relief Fund claims. The HHS Office of Inspector General (OIG) listing, dated October 27, says the six limited partnerships, SNG Bellaire, SNG Hillcroft, SNG Northwest, SNG Pasadena, SNG Sandcastle and SNG Texas City Dialysis, resolved False Claims Act allegations that they submitted false claims to receive Provider Relief Fund payments. Their majority owner, Sankar Nephrology Group, will guarantee the settlement, and the U.S. Attorney’s Office for the District of Massachusetts handled the matter. Who it hits: dialysis operators that took COVID-era relief money. So what: the settlement shows pandemic grants are still being audited years later. The listing does not describe the false claims or admit liability, and we did not retrieve the Justice Department release. Confidence: High on the amount and parties; Low on case details. Source: HHS Office of Inspector General enforcement listing.