Medication management and reconciliation

Status: DETAILED MEDICAL OPERATING SOP DRAFT — human-readable clinical workflow; not yet clinically or operationally approved

Public service anchor: CMS GUIDE RFA Appendix B §§7.1-7.5 ↗. Transition medication work also appears in Appendix B §5.4. The Proxi column identifies candidate automation, not functionality already deployed. The acquired Participant's current executed agreement still needs to be checked before operations are finalized.

Medical SOP purpose and clinical boundary#

This SOP defines how Proxi obtains the best available medication history, preserves each source's claim, compares discrepancies, obtains prescribing-authority reconciliation, coordinates any medication change, communicates an authorized regimen, confirms understanding and practical implementation, and monitors the result.

Medication reconciliation is not selection of the newest or most authoritative-looking list. It is the prescribing-authority clinician's comparison of the best available medication history with current orders, treatment plans, transition information, reported use, supply evidence, allergies and reactions, symptoms, and unresolved questions, followed by an explicit determination of the intended regimen and disposition of every material discrepancy.

The following remain separate even after reconciliation:

• Clinician-intended regimen: what the authorized clinician currently intends the beneficiary to use.
• Order or prescription: the legally valid request issued by an authorized prescriber.
• Transmission and pharmacy response: whether the order or cancellation reached the pharmacy and how the pharmacy responded.
• Dispense or handoff: what the pharmacy or facility actually supplied or handed over.
• Possession: what appears to be present and accessible to the beneficiary, caregiver, or facility.
• Reported use: what the beneficiary or caregiver says is being used, stopped, skipped, changed, or refused.
• Administration: a documented dose actually administered in a facility or by another person.
• Unresolved source assertion: a material fact that remains missing, ambiguous, stale, or conflicted.

Reconciliation does not prove that the beneficiary obtained, understood, or implemented the intended regimen. Likewise, a claim does not prove dispensing, a dispense event does not prove possession, and possession does not prove use.

Order does not prove transmission; transmission does not prove pharmacy acceptance; acceptance does not prove dispensing; a claim does not prove handoff; dispensing does not prove possession; possession does not prove use; and reported use does not prove administration.

CMS RFA §§7.1-7.5 establish the public GUIDE obligations. The detailed interview dataset, discrepancy method, teach-back, monitoring plan, and closure criteria below are Proxi clinical operating design informed by AHRQ MATCH and RED medication-safety guidance; they are not additional CMS requirements.

Monthly monitoring is not monthly reconciliation#

CMS RFA §7.1 requires prescribing-authority review and reconciliation at the comprehensive initial assessment, at future assessments, and periodically when requested by the care team, beneficiary, or caregiver, as appropriate. It does not require monthly reconciliation.

Keep these activities and outcomes separate:

A real no-change reconciliation exists only when the prescribing-authority clinician reviews sufficiently current evidence, disposes every material discrepancy, and explicitly concludes that the intended regimen remains unchanged. “No new claim,” “no source delta,” and “no change reported” do not mean the same thing and do not become reconciliation. Do not create a separate medication contact or clinician review solely because the billing month is otherwise empty.

Proxi supplies or contracts the assigned labor under the validated Participant and Partner Organization arrangement. The enrolled GUIDE Participant retains nondelegable responsibility for the Section 7 service, care-team supervision, clinical quality, disclosure controls, and supporting evidence. External prescribers, pharmacies, facilities, and emergency services retain the clinical, dispensing, administration, or emergency acts only they can furnish.

Authority and role assignment#

The Puerto Rico L2 navigator operation performs no licensed assessment, triage, reconciliation, recommendation, prescription, deprescribing act, treatment decision, or individualized clinical instruction. Every such act routes to the separate U.S. clinical workforce. Before that professional acts, confirm the beneficiary's current physical location and the professional's current authority for that jurisdiction and act. If location or authority is unknown, L0-L2 may gather facts and connect the person, but no clinical decision or new instruction occurs through that route. Immediate safety connection is not delayed for routine intake.

Cross-pillar preparation, no-repeat handoffs, owner acceptance, and shared labor follow 25_GUIDE_Eight_Pillar_Service_Integration.md. A source-separated prepared medication question routes directly to the beneficiary-location-authorized prescribing or other qualified clinical owner; Puerto Rico L2 is never the clinical gateway.

Triggers and required clinical owner#

Minimum medication-history dataset#

For every prescription medication, OTC product, vitamin, supplement, herbal or natural treatment, sample, compounded product, and other substance, obtain as much of the following as the sources support:

• verbatim product name and any source code or image;
• ingredient or product identity only to the specificity actually supported;
• strength or concentration, dosage form, route, amount per dose, frequency, times, duration, and effective dates;
• PRN indication, conditions, interval, and maximum when prescribed or documented;
• taper, cross-titration, alternating-day, multi-strength, conditional-hold, split-tablet, device, or other complex directions;
• indication or purpose as documented by a clinician and as understood by the beneficiary, without converting a lay report into a diagnosis;
• prescribing or recommending clinician, practice, and treatment relationship;
• order, prescription, stop, cancel, dispense, reversal, administration, and transition sources with event and receipt dates;
• whether the item is reportedly possessed, placed in packaging or a pill organizer, used, missed, refused, self-changed, stopped, or administered, including last known dose when clinically relevant;
• pharmacy, facility, mail-order, sample, cash, caregiver, or other supply route and available quantity or days supply;
• reported benefit, problem, symptom, fall, confusion, sedation, swallowing or device difficulty, cost, coverage, shortage, transport, packaging, or other access barrier;
• who organizes, reminds, assists, or administers the medication and what schedule support is currently used; and
• source, reporter, observation time, record time, confidence limitation, correction, and unresolved conflict.

Medication allergies, intolerances, and prior adverse reactions are collected as a separate clinical record. Capture the product, reaction as reported, timing and severity when known, reporter, and source. A vague report is not automatically promoted to a confirmed allergy, and a contradictory “no known allergies” record does not erase it.

No source wins by default. EHR lists, pharmacy claims, bottles, discharge paperwork, facility records, beneficiary reports, and caregiver reports each establish only what that source can prove.

Universal medication-safety bypass#

When any person reports a possible overdose, wrong medication or dose, acute symptom, fall, confusion, sedation, allergic-type reaction, missed critical therapy, self-change, administration error, or request for urgent medication advice:

1. The first human responder confirms identity, callback number, current physical location, medication or substance involved, what was taken or omitted if known, last known dose when safely obtainable, symptoms or event, onset and timing, and actions already taken.
2. The responder records the report verbatim without assigning causality, severity, urgency, or treatment.
3. Immediate danger invokes the approved emergency pathway without delaying for a complete history. Otherwise, connect the beneficiary or caregiver to the beneficiary-location-authorized RN, prescribing clinician, or other approved clinical professional.
4. L1/L2 does not advise starting, stopping, holding, repeating, crushing, splitting, substituting, or changing medication unless relaying an exact instruction previously authorized for that exact situation.
5. Failed connection remains an active escalation. Record who accepted the handoff, the clinical disposition and instructions, emergency action, unsuccessful attempts, and the resulting reconciliation, communication, or monitoring work.
6. Completing a safety handoff does not itself complete medication reconciliation or prove the medication caused the event.

Detailed medication review and reconciliation procedure#

1. Confirm identity, location, participation, and authority. Verify the beneficiary, current physical location and care setting, respondent identity, beneficiary participation, caregiver or representative role when relevant, preferred language, accessibility needs, and the proposed clinician's authority.
2. Build the source-faithful reported-use history before navigator or clinician time. Software presents the source-separated candidate list through an accessible structured text, voice, photo, or assisted intake and asks the beneficiary/caregiver to confirm, correct, or supply what is actually used, how each item is used, what changed, what is missed or refused, what problems or barriers exist, and who assists. Ask explicitly about OTC products, supplements, natural treatments, samples, inhalers, injections, eye or ear products, creams, patches, liquids, and PRN items. L1 pursues disconnected records or helps with the administrative intake. L2 conducts the human relationship-based interview only when the required service or person request calls for it, or accessibility, ambiguity, conflict, distress, disagreement, or relationship context remains.
3. Confirm allergies and previous reactions. Collect the separate allergy/reaction history and preserve disagreements for clinical review.
4. Collect independent sources. Obtain available EHR lists and orders, prior reconciliation, PCP and specialist records, pharmacy and claims events, bottles or photographs, facility MAR or administration records, discharge instructions, home health records, and beneficiary/caregiver reports. Record what is still missing.
5. Normalize identity conservatively. L0 may perform exact approved terminology mapping. Strength, concentration, form, route, release characteristics, salt, compound, combination product, and ambiguous text remain distinct unless the evidence supports the match. Therapeutic equivalence is never an automated identity decision.
6. Compare medication by medication. Identify exact matches and differences involving omission, addition, ingredient, strength, concentration, form, route, dose, frequency, timing, PRN instructions, hold or stop instructions, intended overlap, substitution, indication, prescriber, supply, administration, and reported use. Distinguish documented intentional differences from unexplained differences.
7. Prepare the clinician packet. Present the best available history, every source assertion, allergy/reaction record, literal discrepancies, reported symptoms and actual use, access and administration barriers, transition context, relevant existing clinical information, pending questions, and original source documents. AI may summarize but cannot remove contradictions or declare the list clean.
8. Perform prescribing-authority reconciliation. The clinician evaluates the complete packet and determines, for every medication or substance, whether the intended regimen is to continue, start, stop, hold, change, or use under specified conditions. The clinician records dose, route, frequency, indication or purpose, effective timing, clinically important conditions, rationale for material differences, and required monitoring.
9. Record separate clinical and real-world facts. The clinician separately records the intended regimen, beneficiary-reported use, apparent supply or possession, administration evidence, and remaining uncertainty. The clinical conclusion does not erase contradictory evidence.
10. Classify the reconciliation result. The clinician records complete without changes, complete with changes, or incomplete because material information remains unavailable or disputed. A no-change conclusion requires disposition of every material discrepancy. For an incomplete result, the clinician identifies the current instruction that remains in effect or states that no safe new instruction can be released, lists unresolved questions, assigns follow-up, and defines safeguards.
11. Route every proposed change correctly. Distinguish a GUIDE-originated proposal, an authenticated outside order already issued or effective, an outside recommendation without an order, and a beneficiary self-change. Apply the procedures below.
12. Issue and execute authorized orders. After the required clinical authority and provider agreement are authenticated, the authorized prescriber may create the lawful order or cancellation under clinical policy. Before a non-emergency change is implemented or communicated as active instructions, explain it and record the beneficiary's or authorized representative's choice. Track the recommendation, agreement, order, transmission, pharmacy response, dispensing or handoff, possession, choice, and reported implementation separately.
13. Synchronize required destinations. Update the EHR medication record, care plan, pharmacy, beneficiary instructions, authorized caregiver or representative, facility administration information, schedule support, and applicable clinicians as required. One successful destination does not prove another.
14. Communicate and confirm understanding. Provide accessible clinician-approved instructions and use teach-back. Do not represent a proposal as an active regimen.
15. Implement practical supports. After the regimen is clinically authorized and understood, L2 helps address access, packaging, reminders, pill organizers, applications, caregiver/facility support, and other chosen aids without simplifying conditional clinical directions.
16. Monitor and follow through. Confirm whether the beneficiary obtained and reportedly implemented or refused the regimen, whether symptoms or barriers appeared, whether monitoring occurred, and whether every result reached the responsible clinician. New material information creates new review work rather than silently changing the prior record.

Prescribing-clinician reconciliation checklist#

The prescribing-authority clinician considers, as applicable to the person and medication:

• the indication, current clinical goal, expected benefit, and beneficiary preference;
• exact dose, route, formulation, schedule, duration, PRN conditions, and transition phase;
• therapeutic duplication, intended overlap, interaction, contraindication, and allergy/reaction information;
• age, renal, hepatic, laboratory, vital-sign, diagnostic, or other clinical information required by an approved clinical rule, including whether the information is current and valid;
• symptoms, adverse-effect concerns, falls, cognition, function, behavior, swallowing, device use, and ability to execute the regimen;
• differences between orders, supply, possession, administration, and reported use;
• access, affordability, coverage, shortage, packaging, transportation, caregiver, and facility constraints;
• prescriber and condition ownership, co-management, and the provider whose agreement is required for a GUIDE-originated proposal;
• necessary patient/caregiver education, schedule support, and monitoring; and
• whether each discrepancy is intentional, resolved, still unknown, or requires another professional's action.

A deterministic high-risk, interaction, duplication, dose, or monitoring match creates a clinician-review condition only. It does not create an automatic risk conclusion, recommendation, or medication change. The current CMS DAE performance measure is not an individual deprescribing rule.

GUIDE-originated medication-change procedure#

1. The authorized Participant APN, PA, or physician determines that a medication start, stop, dose, schedule, or other change is clinically advisable and records the exact proposal, rationale, effective timing, and monitoring plan.
2. Identify separately every PCP or specialist to whom the recommendation must be shared and the relevant provider whose agreement is required before the beneficiary changes medication.
3. Prepare the exact proposal for authorized release. Under V1, Proxi may assemble and track it; the human role approved under O-030 releases it.
4. Agreement requires an authenticated response from the relevant provider acting within scope and responding to that exact current proposal. Delivery, elapsed time, silence, office-staff acknowledgment, a response to an old proposal, or partial agreement is not agreement.
5. A modified response creates a new proposal. A declined, missing, stale, wrong-scope, unauthenticated, or revoked response leaves the proposed change inactive while the current regimen remains the operative reference pending authorized disposition.
6. The proposal may be discussed as a proposal, but staff must not present it as active instructions while required agreement remains outstanding.
7. After required provider agreement is authenticated for the exact proposal, the authorized prescriber may issue the lawful prescription or stop order according to clinical policy. Outside-order and emergency pathways remain separate.
8. Before a non-emergency change is implemented or communicated as active instructions, explain the change and record the beneficiary's or decision-specific authorized representative's informed choice. A capable beneficiary's refusal remains separate from the clinical recommendation, lawful order, reported implementation, and caregiver disagreement.
9. Do not release start, stop, hold, or change instructions until the required agreement is complete, a lawful current order exists, and the beneficiary or authorized representative has chosen to proceed, except under an approved emergency pathway.

Outside order, recommendation, and self-change procedure#

• Authenticated external order already issued or effective: preserve it as an outside clinical event, verify source and authority, determine its current applicability, and reconcile it with the current regimen. Do not force it through the GUIDE-originated proposal route merely because GUIDE received it.
• External recommendation without an order: preserve and route it for clinical adoption, rejection, or clarification. It is not active instructions.
• Administrative or ambiguous message: verify the source and exact content; office staff, a fax cover sheet, or an unsigned excerpt cannot create a medication order or agreement.
• Beneficiary self-change or refusal: record actual reported use, reason, symptoms, and decision authority; invoke reconciliation and safety review as applicable. Never treat the action as retrospective authorization.

Order, pharmacy, possession, and implementation procedure#

Confirm separately, as applicable:

1. lawful order or cancellation authored by the authorized prescriber;
2. successful transmission to the verified pharmacy or supplier;
3. pharmacy technical acceptance, rejection, or request for clarification;
4. clinical clarification or substitution decision by the authorized professional;
5. preparation, partial fill, trial fill, emergency supply, transfer, backorder, return-to-stock, or cancellation status;
6. dispensing or handoff to the beneficiary, caregiver, courier, or facility;
7. apparent household or facility possession and accessibility;
8. placement in packaging, pill organizer, reminder, MAR, or administration workflow;
9. beneficiary or caregiver report of starting, stopping, changing, delaying, or refusing; and
10. actual administration evidence when available.

For a stopped or cancelled medication, determine whether previously supplied medication remains possessed, accessible, placed in a pill organizer, administered by a facility, or reportedly taken. L2 may gather facts and provide only approved practical support; disposal, replacement, or clinical instructions require the appropriate authorized source.

Accessible instruction and teach-back procedure#

The clinician-approved instruction must distinguish what continues, starts, stops, changes, remains on hold, or remains uncertain and must include, as applicable, dose, route, timing, PRN or conditional directions, effective date, purpose, monitoring, approved missed-dose instruction, and what to do if a problem occurs.

L2 or another approved care-team member asks the beneficiary or authorized caregiver to explain in their own words:

• which medications continue, start, stop, change, or remain on hold;
• how much, how, and when each applicable item is used;
• any PRN condition, maximum, taper, alternating schedule, or conditional hold;
• which existing supply or packaging is affected;
• what monitoring or follow-up is expected;
• what warning signs and contact actions the clinician approved; and
• who will help and how the schedule support works.

Correct misunderstandings and repeat teach-back. Asking “Do you understand?” is not evidence of comprehension. If understanding cannot be demonstrated, do not document comprehension or automatically infer incapacity. With the beneficiary, identify an authorized support person or another practical aid and return unresolved safety, capacity, swallowing, device, or administration concerns to the appropriate clinician.

Schedule supports are built only from the current authorized regimen. A taper, cross-titration, alternating schedule, PRN maximum, multiple strength, or conditional hold must not be flattened into a static reminder.

Monitoring procedure#

For every medication or change requiring follow-up, the prescribing clinician defines:

• what will be monitored, including symptoms, function, falls, behavior, actual use, access, vital signs, laboratory results, other testing, or a clinical visit as applicable;
• who obtains each input and by what permitted route;
• who is clinically responsible for reviewing the result;
• clinically appropriate timing and what finding requires earlier contact;
• what action or communication is expected after review; and
• how missed, unavailable, stale, conflicting, or late monitoring is escalated.

L0/L1 may remind, retrieve, and track. L2 may support completion and report observations. Only the authorized clinician interprets the result and decides medication action. A reminder sent or test completed does not prove clinical review.

Transition-specific medication procedure#

For transitions, compare all applicable source classes rather than selecting the discharge list by recency:

1. regimen and reported use before the transition;
2. medication actually administered in the facility or emergency setting;
3. discharge or transfer orders and instructions;
4. prescriptions and cancellations actually transmitted;
5. pharmacy responses and supply events;
6. medication physically present at home or the receiving facility;
7. what the beneficiary, caregiver, or facility is currently doing; and
8. pending tests, results, monitoring, and responsibility for follow-up.

The completed transition medication outcome must return to the Care Coordination transition episode. Missing discharge information, a newly issued outside order, rapid readmission, or late corrected record remains visible and creates the applicable follow-up; it does not silently overwrite the reconciled regimen.

Timing and escalation#

Objective completion criteria#

A prescribing-authority medication review or reconciliation is complete only when the record contains:

• the trigger and scope of the review;
• beneficiary identity, current location, respondent and authority facts, and accessibility needs;
• the source-complete medication and allergy/reaction history or an explicit list of unavailable sources;
• every material discrepancy and its prescribing-clinician disposition;
• clinician identity, credentials, beneficiary-location authority, date, and the exact intended regimen;
• separate reported use, supply/possession, administration, and unresolved facts;
• complete-without-change, complete-with-change, or incomplete outcome, with no-change supported by disposition of every material discrepancy;
• for a GUIDE-originated change, the exact sharing recipients, relevant agreement provider, authenticated response to the current proposal, beneficiary decision, and lawful order;
• required EHR, care-plan, pharmacy, beneficiary, caregiver/facility, schedule-support, and other-clinician communication outcomes;
• accessible instruction and teach-back result without unsupported comprehension;
• access, pharmacy, possession, implementation, refusal, and monitoring outcomes as applicable; and
• every unresolved issue, safeguard, responsible owner, timing, and next action.

An alert, completed source comparison, clinician task assignment, transmitted proposal, pharmacy claim, safety handoff, or narrative note alone is not medication-service completion. Case completion and whether an activity qualifies as a GUIDE service remain separate under O-034.

Cross-pillar medication feeds#

This SOP participates in cross-pillar episodes under 25_GUIDE_Eight_Pillar_Service_Integration.md. Medication Management receives service attribution only for an attributable prescribing-authority reconciliation or decision, a truthful incomplete result, an executed medication access or change step, or an authorized monitoring result with the next owner identified. Opening a medication case, ingesting a list, sending a transfer, issuing an order, or obtaining pharmacy acceptance does not silently stand in for the later result.

Assessment opens the required reconciliation occasion and supplies source material. Ongoing Monitoring asks only the bounded current-use or problem question unless a real trigger exists, then follows the exact access, use, or monitoring return without performing reconciliation. During a transition, the medication work remains incomplete until the route-specific authorized clinician produces a complete-no-change, complete-with-change, or truthful incomplete result and any safe current instruction or inability to release a new instruction is explicit under the still-open O-028 authority decision.

What this pillar provides as a service#

Proxi can perform or accelerate intake, retrieval, comparison, task creation, follow-up, communication preparation, status tracking, reminders, and record updates. The required human service remains the beneficiary or caregiver interaction, prescribing-authority reconciliation and judgment, relevant-provider agreement, lawful prescribing or deprescribing, clinical safety response, and care-navigator support.