Last updated: November 2026
Medicare Part D medication therapy management (MTM) is a sponsor program for targeted enrollees under 42 CFR 423.153(d); private fee-for-service MA (MA-PFFS) and PACE organizations are exempt. For plan compliance and pharmacy leaders, Integral Healthcare Solutions (IHS) drafts program documents for clinician approval.
Founded in 2002, IHS provides accreditation consulting, compliance services and program development. The sponsor approves clinical content and submits to CMS.
What is a Part D medication therapy management program?
Paragraph (d) requires MTM for Part D sponsors subject to that paragraph. We read the current text of 42 CFR 423.153 (eCFR text built November 4, 2026; Title 42 last amended October 8, 2026; opened November 5, 2026). In our words, paragraph (d)(1) says:
MTM must be designed to improve targeted beneficiaries' covered Part D drug use to optimize therapeutic outcomes and reduce adverse-event risk, including adverse drug interactions. Enrollment is opt-out only; targeting occurs at least quarterly each plan year. Each enrollee must be offered all minimum services listed below (d)(1).
MTM may be furnished by pharmacists or other qualified providers and may distinguish ambulatory from institutional services (d)(1)(iii) and (iv). The program must be developed with licensed and practicing pharmacists and physicians (d)(3). MTM must coordinate with care management plans established for targeted individuals under section 1807 chronic care improvement programs (CCIPs); sponsors must provide CCIPs drug claims data for their enrollees as CMS specifies (d)(4). Applicants must describe in their applications how implementation resources and time inform MTM provider fees; on request, they must disclose management and dispensing fees and the MTM portion to CMS (d)(5). Sponsors report procedures and performance under CMS guidelines (d)(6).
Who is targeted for MTM, and what are the limits?
An enrollee in the sponsor's Part D plan is targeted by meeting at least one of two groups in (d)(2).
| Group | What the text says |
|---|---|
| Group 1, all three conditions (d)(2)(i) | (A) Multiple chronic diseases, with three the most a sponsor may require for targeted enrollment. (B) Multiple Part D drugs, with eight the most a sponsor may require for targeted enrollment. (C) Likely annual covered Part D drug costs at or above the MTM cost threshold CMS determines. |
| Group 2 (d)(2)(ii) | Beginning January 1, 2022, at-risk beneficiaries as defined in 42 CFR 423.100. |
Three and eight are ceilings, not floors. A sponsor can set lower counts, so more enrollees qualify. Beginning January 1, 2025, a sponsor identifying beneficiaries with multiple chronic diseases must include all ten diseases named in (d)(2)(iii) and may include more: Alzheimer's disease, bone disease-arthritis (including osteoporosis, osteoarthritis and rheumatoid arthritis), chronic congestive heart failure, diabetes, dyslipidemia, end-stage renal disease, HIV/AIDS, hypertension, mental health (including depression, schizophrenia, bipolar disorder and other chronic/disabling mental health conditions) and respiratory disease (including asthma, COPD and other chronic lung disorders). From the same date a sponsor counting drugs must include all Part D maintenance drugs, using a widely accepted, commercially or publicly available drug database, and may include all Part D drugs (d)(2)(iv).
For 2025, paragraph (d)(2)(i)(C)(3) uses the average annual cost of eight generic drugs as defined in 423.4, calculated from the PDE data specified in 423.104(d)(2)(iv)(C). The contract year 2026 memo (May 6, 2025; opened November 5, 2026) states 1,276 dollars for 2026, and the contract year 2027 memo (May 1, 2026; opened November 5, 2026) states 1,340 dollars for 2027.
What services must each enrolled beneficiary be offered?
The minimum level of services includes all of the following under (d)(1)(vii):
- Interventions for both beneficiaries and prescribers (A).
- An annual comprehensive medication review (CMR) with written summaries (B). It must include an interactive consultation by a pharmacist or other qualified provider, in person or by synchronous telehealth. The review may produce a recommended medication action plan. If the beneficiary is offered the CMR but cannot accept because of cognitive impairment, it may be performed with the beneficiary's prescriber, caregiver or other authorized individual.
- Quarterly targeted medication reviews with follow-up interventions when necessary (C).
- Standardized action plans and summaries that comply with CMS requirements for the standardized format (D).
- Beginning January 1, 2022, information about safe disposal of controlled-substance prescription drugs, drug take back programs, in-home disposal and cost-effective disposal methods, provided at least annually as part of the CMR, a targeted medication review or other MTM correspondence or service (E). It must meet all requirements of 42 CFR 422.111(j) (F). The CMS memo says website postings alone do not meet this; electronic delivery is allowed.
The written information under 422.111(j) must include, among other items, the location of two or more drug take back sites in the community where the enrollee resides.
What does CMS require each year?
Each sponsor subject to the MTM requirements submits its program description to CMS annually for review and approval, and a CMS-approved program is one of several required elements in the bid for the upcoming contract year (CMS Part D MTM page, opened November 5, 2026). For contract year 2027 the May 1, 2026 memo gave new and renewing sponsors these dates in the Health Plan Management System (HPMS): module release May 20, 2026; submission deadline June 3, 2026, 11:59 pm PDT; attestation deadline June 17, 2026, 11:59 pm PDT.
After approval, a sponsor may request program changes in five yearly update windows, September 1 to 10 and December 1 to 10 before the contract year and March 1 to 10, June 1 to 10 and September 1 to 10 within it. The memo gives an expected response within 30 days, depending on request volume; requested changes cannot alter bids. It reports Office of Management and Budget approval of the CMR summary format (CMS-10396) through December 31, 2027.
The sponsor's separate MTM website section must explain eligibility, purpose, benefits, free service, the services offered, obtaining documents including the medication list, and obtaining program information. It must explain how members learn they are eligible and enrolled, how CMRs and targeted reviews are conducted and delivered, time commitments and materials provided (42 CFR 423.2265(b)(13); current eCFR, page opened November 5, 2026). The CMS page listed memos through 2027; check for updates.
Who needs this work and what triggers it?
The CMS memos apply these requirements to Part D sponsors, including Employer Group Waiver Plans, but exclude MA-PFFS and PACE organizations. MA-PFFS organizations choosing MTM must follow annual submission and approval. Typical triggers:
- A new sponsor is preparing a first program description.
- The yearly submission is near and targeting logic still reflects an earlier threshold or the pre-2025 rules.
- The record of pharmacist and physician input is thin, or the reporting calendar has gaps.
How IHS helps
IHS drafts program and clinical content for the sponsor's pharmacists and physicians to approve. The steps:
- Design review. IHS identifies gaps and maps requirements to documents and evidence.
- Drafting. IHS drafts the program description, targeting and review workflows, clinical content, safe disposal procedure and reporting calendar.
- Clinician review record. IHS builds the template for recording pharmacist and physician input under (d)(3).
- Readiness check. IHS performs a mock review and supports readiness by tracking unresolved gaps.
The sponsor supplies clinical policies, clinician input, claims and drug data, approves clinical content, and handles HPMS submission and attestation. The real limit: the sponsor's clinicians decide clinical content, and IHS does not file with or contact CMS or predict an outcome. IHS gives no legal advice.
What to have ready
Checklist references use the current eCFR, built November 4, 2026; page opened November 5, 2026.
- A written program description showing the program is established (d)(1) 42 CFR 423.153(d).
- An opt-out enrollment procedure (d)(1)(v) and a targeting schedule that runs at least quarterly (d)(1)(vi) 42 CFR 423.153(d).
- Targeting criteria within the three-disease and eight-drug ceilings that apply the CMS cost threshold and cover at-risk beneficiaries (d)(2) 42 CFR 423.153(d).
- Counting rules that include the ten named diseases and all Part D maintenance drugs, with the drug database named (d)(2)(iii) and (iv) 42 CFR 423.153(d).
- A CMR process with a written summary and a cognitive impairment path (d)(1)(vii)(B) 42 CFR 423.153(d).
- A quarterly targeted review process with follow-up interventions when necessary, and the standardized action plan and summary (d)(1)(vii)(C) and (D) 42 CFR 423.153(d).
- A safe disposal procedure that reaches each targeted enrollee at least annually (d)(1)(vii)(E) and (F) 42 CFR 423.153(d).
- An IHS-prepared record of clinician cooperation (d)(3); no form is prescribed 42 CFR 423.153(d).
- A reporting calendar and data owner (d)(6), plus the website page in 423.2265(b)(13) 42 CFR 423.153(d).
If several are missing, book the free introductory call below before the next update window.
How it compares
MTM differs from broader sponsor compliance work.
- Vendor-operated services. The regulation is written to the Part D sponsor. IHS's reading, dated November 5, 2026, is that the program stays the sponsor's even when a vendor delivers the reviews. This is not legal advice.
- Broader sponsor compliance. IHS covers the Medicare Advantage and Part D compliance program on its compliance program page and audits on its CMS program audit readiness page.
What does it cost?
CMS does not publish an MTM submission fee schedule on the pages we reviewed. IHS scopes each engagement after a free introductory call.
What this is not
This is not legal advice. IHS is a consulting firm, not a law firm, and counsel advises on what the regulation requires of your sponsor.
It is not a clinical decision. The sponsor's pharmacists and physicians decide the clinical design. It is not IHS acting for you with CMS: IHS does not contact CMS or use HPMS for you; IHS drafts, and the sponsor submits and attests.
Frequently asked questions
What must a Part D MTM program include under 42 CFR 423.153(d)?
Part D sponsors subject to paragraph (d) must establish MTM; MA-PFFS and PACE organizations are exempt. It must enroll targeted beneficiaries by opt-out only, target them at least quarterly, and offer each enrollee all of the minimum services in (d)(1)(vii). It must be developed with licensed and practicing pharmacists and physicians.
Who is targeted for MTM, and what are the maximum criteria?
An enrollee in the sponsor's Part D plan qualifies under (d)(2) through either group: multiple chronic diseases (maximum required: three), multiple Part D drugs (maximum required: eight) and likely annual covered Part D drug costs at or above the CMS threshold; or at-risk beneficiary status as defined in 42 CFR 423.100. The disease and drug-counting rules above also apply.
Is MTM enrollment opt-in or opt-out?
Opt-out. Paragraph (d)(1)(v) says the program must enroll targeted beneficiaries using an opt-out method of enrollment only.
What services must each MTM enrollee be offered?
Paragraph (d)(1)(vii) requires beneficiary and prescriber interventions, an annual CMR with written summaries, quarterly targeted reviews with follow-up when necessary, and CMS-standardized action plans and summaries. Safe-disposal information must be provided at least annually, as detailed above.
What is the MTM cost threshold?
It is the annual covered Part D drug cost a beneficiary must be likely to incur, as CMS determines under (d)(2)(i)(C). CMS stated 1,276 dollars for 2026 and 1,340 dollars for 2027 in its memos.
Who must help develop the program?
Licensed and practicing pharmacists and physicians. Paragraph (d)(3) says the program must be developed in cooperation with them. IHS recommends recording their input; the paragraph does not prescribe a form.
What does the sponsor report and submit to CMS?
The sponsor gives CMS information on the procedures and performance of its MTM program according to CMS guidelines (d)(6), and submits its program description each year through HPMS. The contract year 2027 deadline was June 3, 2026.
Does IHS submit anything to CMS?
No. IHS does not submit anything to, call or correspond with CMS. The sponsor submits and attests through its own staff, with counsel.