CMS Pub. 100-08, ch. 10, § 10.6.12

Physicians and practitioners are typically required to submit claims on behalf of beneficiaries for

all items and services they provide for which Medicare payment may be made under Part B.

They are also not permitted to charge beneficiaries in excess of the limits on charges that apply

to the item or service being furnished. However, certain types of physicians and practitioners

may “opt-out” of Medicare. A physician or practitioner who opts-out is not required to submit

claims on behalf of beneficiaries and also is excluded from limits on charges for Medicare-covered services. Medicare does not pay anyone for services (except for certain emergency and

urgent care services) furnished by an opt-out physician or practitioner. Instead, opt-out

physicians and practitioners sign private contracts with beneficiaries. Please refer to CMS Pub.

100-02, Chapter 15, sections 40 - 40.39 for more information regarding the maintenance of opt-out affidavits and the effects of improper billing of claims during an opt-out period.

The instructions in this section 10.6.12 address the contractor’s processing of opt-out affidavits.

(See Pub. 100-02, chapter 15, section 40.8 for private contract definitions and requirements.)

A. Who May Opt-Out of Medicare

Only the following physicians and practitioners (sometimes collectively referenced as “eligible

practitioners” in this section) can “opt-out” of Medicare:

Physicians who are:

• Doctors of medicine or osteopathy,

• Doctors of dental surgery or dental medicine,

• Doctors of podiatry, or

• Doctors of optometry who are legally authorized to practice dentistry, podiatry, optometry,

medicine, or surgery by the state in which such function or action is performed.

Non-physician practitioners who are:

• Physician assistants,

• Nurse practitioners,

• Clinical nurse specialists,

• Certified registered nurse anesthetists,

• Certified nurse midwives,

• Clinical psychologists,

• Clinical social workers,

• Registered dietitians or nutrition professionals who are legally authorized to practice by the

state and otherwise meet Medicare requirements,

• Mental health counselors, or

• Marriage and family therapists

(Organizations are not permitted to opt-out of Medicare.)

This means that neither the eligible practitioner nor the beneficiary submits the bill to Medicare

for services performed. Instead, the beneficiary pays the eligible practitioner out-of-pocket and

neither party is reimbursed by Medicare. In fact, a private contract is signed between the eligible

practitioner and the beneficiary that states, in essence, that neither can receive payment from

Medicare for the services performed. (The contract, though, must be signed before the services

are provided so the beneficiary is fully aware of the eligible practitioner’s opt-out status.)

Moreover, the eligible practitioner must submit an affidavit to Medicare expressing a decision to

opt-out of the program. The contractor’s provider enrollment unit must process these affidavits.

Eligible practitioners who opt-out of Medicare are not the same as non-participating

physicians/suppliers. The latter are enrolled in Medicare and choose on a claim-by-claim basis

whether they want to accept assignment unless the service can only be paid on an assignment-related basis as required by law (e.g., for drugs, ambulance services, etc.). Non-participating

physicians/suppliers must therefore comply with Medicare’s mandatory claim submission,

assignment, and limiting charge rules. Opt-out eligible practitioners, on the other hand, are

excused from the mandatory claim submission, assignment, and limiting charge rules, though

only when they maintain compliance with all of the requirements for opting out.

In an emergency care or urgent care situation, an eligible practitioner who has opted-out may

treat a Medicare beneficiary with whom the eligible practitioner does not have a private contract.

In those circumstances, the eligible practitioner must complete a Form CMS-855 application.

B. Requirements for an Opt-out Affidavit

1. Affidavit Contents

As stated in Pub. 100-02, chapter 15, section 40.9, the affidavit shall state that, upon signing the

affidavit, the eligible practitioner agrees to the following requirements:

• Except for emergency or urgent care services, during the opt-out period the eligible

practitioner will provide services to Medicare beneficiaries only through private contracts,

but for their provision under a private contract, would have been Medicare-covered services;

• The eligible practitioner will not submit a claim to Medicare for any service furnished to a

Medicare beneficiary during the opt-out period, nor will the eligible practitioner permit any

entity acting on the eligible practitioner’s behalf to submit a claim to Medicare for services

furnished to a Medicare beneficiary;

• During the opt-out period, the eligible practitioner understands that the eligible practitioner

may receive no direct or indirect Medicare payment for services that the eligible practitioner

furnishes to Medicare beneficiaries with whom the eligible practitioner has privately

contracted, whether as an individual, an employee of an organization, a partner in a

partnership, under a reassignment of benefits, or as payment for a service furnished to a

Medicare beneficiary under a Medicare Advantage plan;

• An eligible practitioner who opts out of Medicare acknowledges that, during the opt-out

period, the eligible practitioner’s services are not covered under Medicare and that no

Medicare payment may be made to any entity for the eligible practitioner’s services, directly

or on a capitated basis;

• On acknowledgment by the eligible practitioner to the effect that, during the opt- out period,

the eligible practitioner agrees to be bound by the terms of both the affidavit and the private

contracts that the eligible practitioner has entered into;

• Acknowledge that the eligible practitioner recognizes that the terms of the affidavit apply to

all Medicare-covered items and services furnished to Medicare beneficiaries by the eligible

practitioner during the opt-out period (except for emergency or urgent care services furnished

to the beneficiaries with whom the eligible practitioner has not previously privately

contracted) without regard to any payment arrangements the eligible practitioner may make;

• With respect to an eligible practitioner who has signed a Part B participation agreement,

acknowledge that such agreement terminates on the effective date of the affidavit;

• Acknowledge that the eligible practitioner understands that a beneficiary who has not entered

into a private contract and who requires emergency or urgent care services may not be asked

to enter into a private contract with respect to receiving such services;

• Identify the eligible practitioner sufficiently so that the Medicare contractor can ensure that

no payment is made to the eligible practitioner during the opt-out period; and

• Be filed with all MACs that have jurisdiction over claims the eligible practitioner would

otherwise file with Medicare; the initial two-year opt-out period will begin the date on which

the affidavit meeting the requirements of 42 C.F.R. § 405.420 is signed, provided the

affidavit is filed within 10 days after the eligible practitioner signs the latter’s first private

contract with a Medicare beneficiary.

(See Pub. 100-02, chapter 15, section 40.9 for more information on the requirements of opt-out

affidavits. See also section 10.6.12(B)(5) below for acceptable opt-out formats.)

The contractor shall review initial opt-out affidavits to ensure that they contain the following

information about the eligible practitioner to create an affidavit record in PECOS:

• Full name (first, middle and last),

• Birthdate,

• Address, telephone number, and e-mail address

• License information,

• NPI (if one has been obtained),

• SSN (if no NPI has been issued, though note that this cannot be an individual tax

identification number (ITIN)), and

• Contact person name, telephone number, and e-mail address (if different from the opting-out

physician or practitioner)

If, to create a PECOS affidavit record, the contractor needs to obtain data that is missing from an

affidavit, it may (1) obtain this information from other sources (such as the state license board)

or (2) contact the eligible practitioner only one time directly. The contractor shall not use

Internet-based PECOS or the Form CMS-855 to secure the data from the eligible practitioner, for

the eligible practitioner is not enrolling in Medicare. If the eligible practitioner is requested to

submit missing information to permit the processing of the affidavit and fails to do so within 30

days, the contractor shall reject the opt-out affidavit.

2. Opting-Out and Ordering/Certifying/Referring

If an eligible practitioner who wishes to opt-out elects to order/certify/refer Medicare items or

services, the contractor shall develop for the date of birth (if not provided on the affidavit):

If this information is requested but not received, the eligible practitioner’s affidavit can still be

processed; however, the eligible practitioner cannot be listed as an ordering/certifying/referring

provider.

3. Adverse Actions

The contractor shall review the List of Excluded Individuals and Entities (LEIE) and the System

for Award Management (SAM) for all eligible practitioners who submit opt-out affidavits.

Excluded eligible practitioners may opt-out of Medicare but cannot order certify/refer.

As noted in 42 CFR § 405.425(i) and (j), individuals who are revoked from Medicare cannot

order, certify, or refer Part A or B services or items to Medicare beneficiaries if they opt-out of

Medicare after revocation.

4. No Dual Status

a. Form CMS-855O - Eligible practitioners cannot be enrolled via the Form CMS-855O and

actively opted-out simultaneously. Prior to processing an initial Form CMS-855O or opt-out

affidavit submission, therefore, the contractor shall confirm that an approved Form CMS-855O

enrollment or valid opt-out affidavit does not exist in PECOS. If an approved enrollment or

affidavit indeed exists, the contractor shall return the pending application.

b. Form CMS-855I – A Form CMS-855I enrollment can simultaneously exist with a valid opt-out affidavit only if the Form CMS-855I is to bill for emergency services. If a Form CMS-855I

is received and an opt-out affidavit is active, the contractor shall contact the eligible practitioner

(via any means) to clarify if the latter submitted the application to solely bill for emergency

services provided to a beneficiary. If so, the application shall be processed via normal

procedures. If not, the application may be returned. (See Pub. 100-02, chapter 15, section 40.28

for more information on emergency and urgent care services.)

An eligible practitioner who has opted out of Medicare need not also enroll via the Form CMS-

855O if the eligible practitioner wishes to order/refer/certify (e.g., providing the necessary

information on the affidavit per this section 10.6.12).

5. Acceptable Opt-Out Affidavit Formats

The contractor may provide a sample opt-out affidavit form for eligible practitioners to complete.

The opt-out affidavit form must provide spaces for the eligible practitioners to furnish their

personal information.

Eligible practitioners may also create their own affidavit. If the eligible practitioner elects to do

so, the affidavit should include information found in section 10.6.12(B)(1) to ensure timely

processing of the opt-out affidavit.

The contractor and eligible practitioners may use the information below as an opt-out affidavit

form.

I, {Enter Physician/Non-Physician Practitioner Name}, being duly sworn, depose and say:

• Opt-out is for a period of two years. At the end of the two-year period, my opt-out status will

automatically renew. If I wish to cancel the automatic extension, I understand that I must

notify my Medicare Administrative Contractor (MAC) in writing at least 30 days prior to the

start of the next two-year opt-out period.

• Except for emergency or urgent care services (as specified in the Medicare Benefit Policy

Manual Publication 100-02, Chapter 15 §40.28), during the opt-out period I will provide

services to Medicare beneficiaries only through private contracts that meet the criteria of

§40.8 for services that, but for their provision under a private contract, would have been

Medicare-covered services.

• I will not submit a claim to Medicare for any service furnished to a Medicare beneficiary

during the opt-out period, nor will I permit any entity acting on my behalf to submit a claim

to Medicare for services furnished to a Medicare beneficiary, except as specified in § 40.28.

• During the opt-out period, I understand that I may receive no direct or indirect Medicare

payment for services that I furnish to Medicare beneficiaries with whom I have privately

contracted, whether as an individual, an employee of an organization, a partner in a

partnership, under a reassignment of benefits, or as payment for a service furnished to a

Medicare beneficiary under Medicare Advantage.

• I acknowledge that during the opt-out period, my services are not covered under Medicare

and that no Medicare payment may be made to any entity for my services, directly or on a

capitated basis.

• I acknowledge and agree to be bound by the terms of both the affidavit and the private

contracts that I have entered into during the opt-out period.

• I acknowledge and understand that the terms of the affidavit apply to all Medicare-covered

items and services furnished to Medicare beneficiaries by myself during the opt-out period

(except for emergency or urgent care services furnished to the beneficiaries with whom I

have not previously privately contracted) without regard to any payment arrangements I

may make.

• I acknowledge that if I have signed a Part B participation agreement, that such agreement

terminates on the effective date of this affidavit.

• I acknowledge and understand that a beneficiary who has not entered into a private contract

and who requires emergency or urgent care services may not be asked to enter into a private

contract with respect to receiving such services and that the rules of §40.28 apply if I furnish

such services.

• I have identified myself sufficiently so that the MAC can ensure that no payment is made to

me during the opt-out period. If I have already enrolled in Medicare, I have included my

Medicare PTAN, if one has been assigned. If I have not enrolled in Medicare, I have

included the information necessary to opt-out.

• I will file this affidavit with all MACs who have jurisdiction over claims that I would

otherwise file with Medicare and the initial two- year opt-out period will begin the date the

affidavit meeting the requirements of 42 C.F.R. §405.420 is signed, provided the affidavit is

filed within 10 days after the physician/practitioner signs the latter’s first private contract

with a Medicare beneficiary.

Eligible practitioners should also be encouraged to include the following information (to

complete an affidavit record in PECOS): Medicare Identification Number (if issued); date of

birth; specialty; e-mail address; any request to order/certify/refer.

C. Effective Date of an Opt-Out Period

As noted in Pub. 100-02, chapter 15, section 40.17, eligible practitioners receive effective dates

based on their participation status.

1. Eligible Practitioners Who Have Never Enrolled In Medicare

Eligible practitioners need not enroll prior to opting-out of Medicare. If a non-enrolled eligible

practitioner submits an opt-out affidavit, the effective date of the opt-out period begins the date

the affidavit is signed by the eligible practitioner.

2. Non-Participating Practitioners

If an eligible practitioner who is a non-participating provider decides to terminate an active

Medicare billing enrollment and instead opt-out of Medicare, the effective date of the opt-out

period begins the date the affidavit is signed by the eligible practitioner.

3. Participating Practitioners

If an eligible practitioner who is a participating provider (one who accepts assignment for all

Medicare claims) decides to terminate an active Medicare billing enrollment and opt-out of

Medicare, the effective date of the opt-out period begins the first day of the next calendar

quarter. Per 42 CFR § 405.410(d), an eligible practitioner may opt-out of Medicare at the

beginning of any calendar quarter, provided that the affidavit described in 42 CFR § 405.420 is

submitted to the applicable contractor(s) at least 30 days before the beginning of the selected

calendar quarter. (The contractor shall, however, add 5 calendar days to the 30-day period to

allow for mailing.) An opt-out affidavit must therefore be submitted at least 30 days before the

first day of the calendar quarter in order to receive January 1, April 1, July 1 or October 1 as the

effective date. If the opt-out affidavit is submitted within 30 days prior to January 1, April 1,

July 1 or October 1, the effective date would be the first day of the next calendar quarter. (For

example, an enrolled participating eligible practitioner’s opt-out affidavit was submitted on

December 10. The eligible practitioner’s effective date could not be January 1, for the affidavit

was not submitted at least 30 days prior to January 1. The effective date would be April 1.) The

eligible practitioner would need to remain enrolled as a participating supplier until the end of the

next calendar quarter so that claims can be properly submitted until the opt-out period begins.

4. Opt-Out After Enrollment

(This section 10.6.12(C)(4) applies notwithstanding any instruction to the contrary in this

chapter.)

If an enrolled physician or eligible practitioner is now opting-out, the existing PECOS

enrollment record shall be end-dated the same day as the affidavit effective date.

D. Emergency and Urgent Care Services

If an eligible practitioner who has opted-out provides emergency or urgent care services, the

eligible practitioner must apply for enrollment via the Form CMS-855I. Once the eligible

practitioner receives a PTAN, the eligible practitioner must submit the claim(s) for any

emergency or urgent care service furnished. The contractor shall contact its PEOG BFL for

additional guidance when this type of situation arises. (See Pub. 100-02, chapter 15, section

40.28 for more information on emergency and urgent care services.)

E. Termination of an Opt-Out Affidavit

As noted in Pub. 100-02, chapter 15, section 40.35, an eligible practitioner who has not

previously opted-out may terminate an opt-out period early. However, the eligible practitioner

must submit written notification thereof (with the eligible practitioner’s signature) no later than

90 days after the effective date of the initial 2-year opt-out period. To properly terminate an

affidavit, moreover, the eligible practitioner must:

1. Not have previously opted-out of Medicare (the eligible practitioner cannot terminate a

renewal of the opt-out);

2. Notify all the MACs that the eligible practitioner has filed an affidavit no later than 90 days

after the effective date of the affidavit;

3. Notify all beneficiaries (or their legal representation) with whom the eligible practitioner

entered into private contracts of the eligible practitioner’s decision to terminate an opt-out

and of the beneficiaries’ right to have claims filed on their behalf with Medicare for the

services furnished during the period between the effective date of the opt-out and the

effective date of the termination of the opt-out period and;

4. Refund to each beneficiary with whom the physician or practitioner has privately contracted

all payments collected in excess of the Medicare limiting charge or deductibles and

coinsurance.

For eligible practitioners who were previously enrolled to bill Medicare for services, the

contractor shall reactivate the eligible practitioner’s enrollment record in PECOS and reinstate

the PTAN as if no opt-out affidavit existed. The eligible practitioner may bill for services

provided during the opt-out period.

For eligible practitioners who were not previously enrolled to bill Medicare for services, the

contractor shall remove the affidavit record from PECOS; this will help ensure that the eligible

practitioner can submit the appropriate application(s) (via PECOS or paper Form CMS-855 for

individual and/or reassignment enrollment) in order to establish an enrollment record in PECOS

and thus bill for services rendered during the opt-out period.

F. Opt-Out Period Auto-Renewal and Cancellation of the Opt-Out Affidavit

1. General Policies

Eligible practitioners who initially opted-out or renewed an affidavit on or after June 16, 2015

need not submit a renewal of their affidavit. The opt-out will be automatically renewed for

another 2-year period. Yet if the eligible practitioner decides to cancel the opt-out, the eligible

practitioner must submit a written notice to each contractor to which would file claims (absent

the opt-out) not later than 30 days before the end of the current 2 year opt-out period.

If the eligible practitioner decides to enroll in Medicare after an opt-out is canceled, the eligible

practitioner must submit a Form CMS-855I application. The effective date of enrollment,

however, cannot be before the cancellation date of the opt-out period. (For example, suppose an

eligible practitioner submits a cancellation of opt-out to end the period on March 31, which is

two years from the eligible practitioner’s opt-out affidavit effective date. The eligible

practitioner’s requested effective date of enrollment cannot be before April 1.)

If the eligible practitioner submits a cancellation request within 30 days of the end of the current

opt-out period or after the opt-out period automatically renews, the contractor shall return the

cancellation request to the eligible practitioner and provide appeal rights.

2. Auto-Renewal Report and Opt-Out Renewal Alert

The contractor shall issue an Opt-Out Renewal Alert Letter (found in section 10.7.14(E) of this

chapter) to any eligible practitioner whose opt-out period is set to auto-renew. For this purpose,

CMS will provide a monthly opt-out report to all contractors via the Share Point Ensemble site.

The contractor shall access the report monthly through the Share Point Ensemble site. The

contractor shall also review the opt-out report for opted-out eligible practitioners that will auto-renew in the next three-and-a-half months. In addition, the contractor shall issue an Auto-Renewal Alert Letter to eligible practitioners at least 90 days prior to the auto-renewal date; the

eligible practitioner will thus have at least 60 days prior to the date a cancellation notice must be

submitted to cancel the current opt-out.

The Opt-out Auto-Renewal Alert Letter will provide (1) the date on which the current opt-out

period will be auto renewed and (2) the date by which the eligible practitioner will need to

submit a cancellation request. The letter will also furnish the eligible practitioner appeal rights if

the latter fails to submit a cancellation request and the opt-out renews.

The contractor shall (1) complete the Opt-Out Renewal Alert Letter Report to include the date

the Alert Letter was issued, (2) post its reports no later than the 15th of the following month to

the Share Point Ensemble site, and (3) email its PEOG BFL when the report has been posted.

If an opted-out eligible practitioner submits a Form CMS-855I without submitting a cancellation

request of the opt-out, the contractor shall develop for the cancellation notice. Once the

cancellation notice is received, the contractor shall then process the application(s).

If the eligible practitioner submits a cancellation request within 30 days of the end of the current

opt-out period or after the opt-out period automatically renews, the contractor shall return the

cancellation request to the eligible practitioner and provide appeal rights using the Late

Cancellation Request return letter. In addition, if the eligible practitioner submits a cancellation

request more than 90 days prior to the auto-renewal date, the contractor shall return the

cancellation request to the eligible practitioner using the Cancellation Request Received Too

Early return letter.

G. Failure to Properly Cancel or Terminate Opt-Out

Eligible practitioners who fail to properly cancel or terminate their opt-out may appeal the

decision to continue (1) the auto-renewal of the opt-out or (2) the eligible practitioner’s initial

opt-out period.

Opt-out approval letters include appeal rights for eligible practitioners who initially opt-out and

fail to properly terminate the opt-out within 90 days of the approval.