How to Opt Out of Medicare for a DPC Practice (Step by Step for 2027)

How Do You Opt Out of Medicare for a DPC Practice?

To opt out of Medicare for a direct primary care practice, you sign an opt-out affidavit and file it with every Medicare Administrative Contractor (MAC) you would otherwise bill, then sign a private contract with each Medicare patient before you treat them. The opt-out lasts two years and renews automatically unless you cancel in writing at least 30 days before the period ends. A first-time opt-out can be undone within 90 days, and emergency or urgent care for a Medicare patient without a contract is still billed to Medicare.

The rules live in 42 CFR part 405, subpart D, sections 405.400 through 405.455, and CMS explains how its contractors apply them in the Medicare Program Integrity Manual, chapter 10, section 10.6.12. This guide walks through each step in order, with the rule linked at every turn.

This is general information, not legal advice. A health care attorney can review your affidavit and private contract before you file.

Do You Have to Opt Out of Medicare to Run a DPC?

Not every DPC has to opt out. CMS's Manage Your Enrollment page says physicians and practitioners who see Medicare patients but don't want to enroll in Medicare must opt out, and that if you don't see Medicare patients, you don't have to enroll in or opt out of Medicare at all. So a practice with no Medicare patients can leave this step for later.

If you do want to care for patients 65 and older inside a flat membership, opt-out is the usual route, because a private contract is what lets the patient pay you directly for services Medicare would otherwise cover. In the DPC Alliance's State of DPC report (survey collected late 2024, published July 2026), 80.7% of surveyed physicians had opted out. Our guide to direct primary care for seniors on Medicare explains the same arrangement from the patient's side.

A few ground rules shape the decision:

• Opt-out is all or nothing. CMS says you cannot opt out for some Medicare patients and services but not others.
• It belongs to the clinician, not the clinic. The Program Integrity Manual says organizations are not permitted to opt out, so each doctor, NP or PA in your practice files their own affidavit. Your business entity choice matters for other reasons, covered in PLLC vs LLC for a DPC.
• Not every license is eligible. Under 42 CFR 405.400, eligible physicians are MDs, DOs, dentists, podiatrists and optometrists, and eligible practitioners include nurse practitioners, physician assistants, clinical nurse specialists, nurse midwives and several behavioral health and nutrition professionals. NPs planning their own practice can also read can nurse practitioners open a DPC.
• You can't hold both statuses. CMS says you can't be enrolled in Medicare and opted out at the same time, with one exception for billing emergency and urgent care, covered below.

How to Opt Out of Medicare, Step by Step

Step 1. Know your current Medicare status

Your starting point decides when your opt-out takes effect. You are either never enrolled in Medicare, enrolled as a nonparticipating provider, or enrolled as a participating provider (one who signed a Part B participation agreement). If you are coming from an employed job, your MAC can tell you how your record is set up, and the leaving employed medicine for DPC guide covers the rest of that move.

Step 2. Find every MAC you would bill

42 CFR 405.410(b) requires an affidavit with each MAC you would file claims with if you hadn't opted out. For a single-state DPC that is usually one contractor, and CMS says that if you opt out in several MAC jurisdictions you file a separate affidavit with each. CMS keeps a directory of Medicare Administrative Contractors by jurisdiction, and your MAC's provider enrollment site will have its standard affidavit form.

Step 3. Prepare the opt-out affidavit

You can use your MAC's form or write your own (the Program Integrity Manual includes sample wording). Either way, 42 CFR 405.420 says it must be in writing, signed by you, and include your full name, address, phone number and NPI, along with statements that you:

• Will treat Medicare patients only through private contracts, except for emergency or urgent care.
• Will not submit claims to Medicare, or let anyone submit them for you, and will take no direct or indirect Medicare payment, including through an employer or a Medicare Advantage plan.
• Accept that any Part B participation agreement ends on the affidavit's effective date.
• Won't ask a patient who needs emergency or urgent care to sign a private contract for that care.

The manual also lists what MACs need to build your record in PECOS, Medicare's enrollment system, including your birthdate, email and license information. If you will order labs, imaging or referrals for Medicare patients, add a request to order, certify and refer. A MAC that asks for missing details and doesn't get them within 30 days rejects the affidavit.

Step 4. Write your private contract

The private contract is the document each Medicare patient signs, and 42 CFR 405.415 is specific about it. It must be in writing, in print large enough for the patient to read, and signed by both of you. It must state:

• Whether you are excluded from Medicare.
• That the patient accepts full responsibility for paying your charges, and understands Medicare limits don't apply to what you charge.
• That the patient won't submit a claim to Medicare or ask you to.
• That Medicare won't pay for your services, and that Medigap plans won't pay and other supplemental plans may not.
• That the patient can still get Medicare-covered care from clinicians who haven't opted out, and isn't required to sign private contracts with anyone else.
• The expected or known start and end dates of your current two-year opt-out period.

It can help to keep the private contract separate from your membership agreement, since it renews on its own cycle. The DPC laws by state guide covers what your state may require in the membership agreement.

Step 5. File on time

If you have never enrolled or were nonparticipating, 42 CFR 405.410(c) starts your opt-out on the date you sign the affidavit, provided you file it within 10 days after signing your first private contract with a Medicare patient. File late and the period starts when the last affidavit is filed, and any care you gave a Medicare patient before then falls under standard Medicare rules.

If you are a participating provider, section 405.410(d) lets you opt out only at the start of a calendar quarter (January 1, April 1, July 1 or October 1), and the affidavit must reach your MAC at least 30 days before that quarter begins. The Program Integrity Manual adds 5 calendar days for mailing and gives an example, where an affidavit submitted on December 10 cannot take effect January 1 and starts April 1 instead. You stay enrolled and keep billing Medicare normally until the quarter begins.

Step 6. Give, keep and renew the contracts

Each patient gets a copy of their signed contract before you provide any care under it. You keep the signed original for the whole two-year period, show it to CMS on request, and sign a new contract with each Medicare patient every period, per section 405.415(l) through (o). 42 CFR 405.435 treats missing contracts as a failure to maintain your opt-out.

When Does Your Medicare Opt-Out Start?

If you are already enrolled, the manual says your PECOS enrollment record is end-dated the same day your opt-out takes effect. Until then you bill Medicare as usual, so a participating doctor can pick the quarter that lines up with the DPC's opening date.

How Long Does a Medicare Opt-Out Last, and Does It Renew Automatically?

Each opt-out period lasts two years and renews on its own. The statute, 42 U.S.C. 1395a(b)(3)(D), defines the opt-out as the two-year period starting when the affidavit is signed plus each later two-year period, unless you give notice at least 30 days before the current period ends. That automatic renewal came from the Medicare Access and CHIP Reauthorization Act of 2015, and CMS's Medicare Benefit Policy Manual, chapter 15, section 40.9, says it applies to affidavits filed on or after June 16, 2015. You don't refile the affidavit, but every Medicare patient on your panel signs a new private contract listing the new period's dates.

CMS also builds in a reminder. The Program Integrity Manual tells MACs to send an Opt-Out Renewal Alert Letter at least 90 days before your renewal date, giving you at least 60 days to decide before the cancellation deadline. Our free Medicare opt-out planner does the same math from your effective date, so you can put every renewal and deadline on the calendar the day your opt-out is approved.

How Do You Cancel a Medicare Opt-Out?

To cancel, send written notice to each MAC you filed an affidavit with, saying you don't want the opt-out extended for another two years. 42 CFR 405.445(a) requires that notice no later than 30 days before the end of your current two-year period. CMS's enrollment page says to mail the request, and that if it doesn't arrive in time your opt-out renews for another two-year cycle.

The window has two edges. The Program Integrity Manual says MACs return a cancellation that arrives within the last 30 days of the period or after the renewal as late, with appeal rights, and return one that arrives more than 90 days before the renewal date as too early. In practice, the safe time to send it is between 90 and 30 days before your period ends.

If you plan to bill Medicare again after cancelling, you enroll with Form CMS-855I, and your enrollment can't start before the opt-out ends. The manual's example is a cancellation that ends the opt-out on March 31, where the earliest enrollment date is April 1.

Can You Undo a Medicare Opt-Out in the First 90 Days?

Yes, once. 42 CFR 405.445(b) lets you terminate an opt-out early if all of these are true:

1. You have never opted out of Medicare before.
2. You notify every MAC you filed an affidavit with no later than 90 days after the effective date of your initial two-year period.
3. You refund each private-contract patient anything you collected above the Medicare limiting charge (for physicians) or above the deductible and coinsurance (for practitioners).
4. You tell each private-contract patient about the termination and their right to have claims filed with Medicare for the care you gave between the opt-out date and the termination date.

Done properly, section 405.445(c) reinstates you in Medicare as if you never opted out. The Program Integrity Manual says a previously enrolled clinician's billing number is reinstated and they can bill for care given during the opt-out. A renewed opt-out can't be terminated early.

What About Emergency and Urgent Care for Medicare Patients?

You can always treat a Medicare patient in an emergency, contract or not. Under 42 CFR 405.415(k), a patient can't be asked to sign a private contract while they need emergency or urgent care. Section 405.400 defines urgent care services as care needed within 12 hours to avoid the likely onset of an emergency medical condition.

What happens next depends on whether the patient already has a contract with you:

• No private contract. 42 CFR 405.440 says you must submit a claim to Medicare and may collect no more than the Medicare limiting charge (physicians) or the deductible and coinsurance (practitioners). The Program Integrity Manual says you enroll with Form CMS-855I to get a billing number for those claims, which is the one case where enrollment and opt-out can exist side by side.
• Existing private contract. Section 405.440(c) says emergency and urgent care for a patient who signed before the condition began is furnished under the terms of that contract.

Can an Opted-Out DPC Doctor Still Order Labs, Imaging and Referrals?

Yes, and this is what makes opt-out workable for primary care. 42 CFR 405.425(i) lets an opted-out physician or practitioner who isn't excluded from Medicare, and whose enrollment hasn't been revoked, order, certify the need for, prescribe and refer for Medicare-covered items, services and drugs, as long as they aren't paid for those services. Your patient's outside labs, imaging, specialist visits and Part D prescriptions can still be covered by Medicare.

The Program Integrity Manual says you don't need a separate Form CMS-855O enrollment to order and refer if the affidavit carries the needed details, and that without your date of birth the MAC can't list you as an ordering, certifying or referring provider. CMS publishes opt-outs in its opt-out affidavits dataset, where you can confirm your record after approval.

Medicare Advantage follows the same line. Under 42 CFR 405.455 and 42 CFR 422.220, Advantage plans can't pay an opted-out clinician for Medicare-covered services, apart from emergency or urgent care for a patient without a private contract.

What Happens If the Opt-Out Paperwork Is Wrong?

The rules separate a bad start from a slip later on. Under 42 CFR 405.430, if the affidavit doesn't meet the requirements, or a private contract signed before the affidavit was filed is defective, the opt-out attempt is nullified and all of your private contracts for that two-year period are void. You then have to submit claims to Medicare for the covered care you gave, but you may try to opt out again at any time.

A slip during the opt-out period is stricter. Section 405.435 covers knowingly and willfully billing Medicare, treating Medicare patients without valid contracts, mishandling emergency billing, or not keeping contracts. Any of those voids your contracts and your opt-out for the rest of the two-year period, and you can't opt out again until that period ends. The regulation gives you a way back if you make good-faith corrections, such as refunds, within 45 days of a MAC's notice or of finding the problem yourself, whichever comes first. CMS decisions on these questions can be appealed under 42 CFR 405.450.

Medicare Opt-Out Deadlines at a Glance

Keeping Your Opt-Out Calendar From Slipping

The opt-out is a few pages of paper, but it sets a schedule that runs as long as you practice. Every Medicare member needs a signed contract before their first visit and a fresh one every two years, while the MAC issues its own letters. Those dates usually sit apart from the EHR and the billing tool, which is how a deadline slips past.

Start by entering your effective date in the Medicare opt-out planner and putting each date it shows on the clinic calendar. If you would rather not track it by hand, Tabflows is a dedicated tech team that connects the tools your clinic already uses, so follow-ups land in one shared task list for your team.

If you are still planning the practice, the how to start a DPC practice guide puts opt-out in order with licensing, entity and software, and the DPC credentialing and licenses checklist lists the other registrations to file in the same months.