Micelle 60 Access Program.
The program framework gives care organizations documents, forms, training, and reports to review as a team.
Planned implementation model
Five stages, one accountable pathway.
Select a stage to see organization responsibilities, Micelle's planned support, and the relevant documents. This is not an operating supply service.
01Product review
- Organization responsibilities
- Evaluate the product definition, federal and state law, evidence and procurement suitability; keep the organization's own approval record.
- Micelle's planned support
- Provide the development specification and source-linked Quality Passport examples, without claiming released-product compliance.
Relevant documents
Link to this stage02Organization implementation plan
- Organization responsibilities
- Elect the incentive if appropriate; prepare, submit and maintain a CMS-required plan covering product, eligibility, amount and frequency, safeguards, distribution and oversight. CMS approval belongs to CMS.
- Micelle's planned support
- Offer an adaptable access framework and source-linked CMS crosswalk for the organization's review.
Relevant documents
Link to this stage03Shared decision-making
- Organization responsibilities
- An affiliated physician determines appropriateness, reviews medications and interactions, documents goals, preferences, risks and benefits, and plans follow-up.
- Micelle's planned support
- Provide patient discussion materials, not an individual medical recommendation or eligibility decision.
Relevant documents
Link to this stage04Supply
- Organization responsibilities
- Arrange lawful procurement, inventory, storage and qualified-physician supply through the participant; do not direct beneficiaries to retail reimbursement.
- Micelle's planned support
- If product is released, provide lot-labelled product and handling records under agreed arrangements; no supply service is live now.
Relevant documents
Link to this stage05Lot records and reporting
- Organization responsibilities
- Keep organization-controlled records and submit CMS-required quarterly reports; respond to requests and product notices. Do not place patient information in public examples.
- Micelle's planned support
- Plan a public Quality Passport for each released lot and a checked de-identified export. The sample quarterly file is synthetic, not an actual CMS submission.
Relevant documents
Link to this stage
Example quarterly reporting output uses synthetic data only. It is not an actual CMS report, beneficiary record or proof of operational reporting.
What it is
An implementation register around the product.
The Access Program groups product documents, controlled forms, training records, and reports into an implementation register. The participating organization retains patient records, makes and documents eligibility decisions, and owns its plan and submissions.
What it includes
Eleven parts for your team.
- 01
Briefing pack
The briefing pack gives a one-page overview. It includes the CMS program context. It has the product specification as it stands, the quality model, and the document set.
- 02
Implementation Plan support
Your organization can adapt the product, distribution, and safeguards sections. They cover the product description and label directions. They cover the annual cap, lot tracking, notices, the concern route, storage, and handling.
- 03
Eligibility screening checklist
The checklist cites your organization's own criteria. These include beneficiary alignment, age, frailty exclusion, conditions, pregnancy or breastfeeding, and a physician's recorded decision. Your care team uses its own criteria.
- 04
Shared decision-making template
The template records benefits and risks discussed. It records goals, preferences, medication review, potential interactions, and a follow-up plan. It logs materials given and the lot supplied. It exports as a PDF or plain text for your records.
- 05
Product qualification records
If the program opens, each released lot will have a selected certificate and definition check for the organization’s qualification file.
- 06
Supply log by lot
The log records the lot, quantity, date, supplying physician, and your own patient identifier. It supports quarterly counts. It helps your organization trace a lot to people who received it.
- 07
Physician module
The physician module takes 20 minutes. It covers the product, label, quality, and lot pages. It also covers eligibility, documentation, interaction references, supplying and logging, and concern reporting. Your team gets a completion record for its files.
- 08
Patient materials
Get the information sheet and discussion guide. Spanish page structure and large-text mode are available. Audio will be added only after files and controls are verified.
- 09
Quarterly report pack
A planned pack will support the organization’s own reporting. It will cover units supplied by lot, certificates, notices, product concerns tied to those lots, changes, and service measures.
- 10
Law brief
The narrower Section 781 exclusions begin November 12, 2026. The broader finished-product restriction, including the more-than-0.4 mg combined-total-per-container threshold, begins December 11, 2026. The brief links the enacted sources and keeps that federal timing separate from product-specific or CMS eligibility decisions.
- 11
Implementation support
The implementation function supports kickoff and planned check-ins through first supply. It also supports orders, notices, reports, and escalation.
Sourced timeline
Federal hemp rules change in two stages.
Sources checked 27 September 2026.
- 01
Limited exclusions begin
The Section 781 amendments begin only for the two cross-referenced exclusions covering certain intermediate and final products with cannabinoids the cannabis plant cannot naturally produce.
Public Law 119-37 § 781 (opens an external website) - 02
Broader amendments begin
The broader amendments include the finished-product restriction for more than 0.4 mg combined total per container of total tetrahydrocannabinols, including THCA, plus the other cannabinoids specified in the statute.
Public Law 119-103 § 2019 (opens an external website)
This federal threshold does not by itself establish that Micelle 60 is compliant, approved, released, or eligible for any CMS program. State law and product-specific testing still matter.
What stays with you
Your decisions and patient records.
Your organization keeps patient identity and clinical records. Your care team makes and records eligibility and physician decisions. Your organization owns its plan and submission.
Support is documented apart from product supply for your compliance review.
Today
Review the framework before product release.
See the sample organization workspace, download the access framework, or request a briefing with your team.