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CMS Pub. 100-02, ch. 15, § 40.9

Requirements of the Opt-Out Affidavit

activein force · 2026-08-25 – presentas-observed

The private contracting/opt-out provisions at section 1802(b) of the Act were amended by section 106(a) of

MACRA. Prior to the MACRA amendments, the law specified that physicians and practitioners may opt-out for a 2-year period. Individuals that wished to renew their opt-out at the end of a 2-year opt-out period

were required to file new affidavits with their MAC. Section 106(a) of the MACRA amends section

1802(b)(3) of the Act to require that opt-out affidavits filed on or after June 16, 2015, automatically renew

every 2 years. Therefore, physicians and practitioners that filed opt-out affidavits on or after June 16, 2015,

are not required to file renewal affidavits to continue their opt-out status. Furthermore, physicians and

practitioners who filed opt-out affidavits on or after June 16, 2015, and who do not want their opt-out status

to automatically renew at the end of a 2-year opt-out period may cancel the automatic extension by notifying

their MACs in writing at least 30 days prior to the start of the next 2-year opt-out period. Valid opt-out

affidavits signed before June 16, 2015, will expire 2 years after the effective date of the opt-out. If

physicians and practitioners that filed affidavits effective before June 16, 2015, want to extend their opt-out,

they must submit a renewal affidavit within 30 days after the current opt-out period expires to all contractors

with which they would have filed claims absent the opt-out.

Under 1802(b)(3)(B) and (D) of the Act and Medicare regulations, a valid affidavit must:

• Be in writing and be signed by the physician/practitioner;

• Contain the physician’s or practitioner’s full name, address, telephone number, NPI or billing

number (if one has been assigned), or, if an NPI has not been assigned, the physician’s or

practitioner’s tax identification number (TIN);

• State that, except for emergency or urgent care services (as specified in §40.28), during the opt-out

period the physician/practitioner 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;

• State that the physician/practitioner will not submit a claim to Medicare for any service furnished to

a Medicare beneficiary during the opt-out period, nor will the physician/practitioner permit any

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

furnished to a Medicare beneficiary, except as specified in §40.28;

• State that, during the opt-out period, the physician/practitioner understands that the

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

physician/practitioner furnishes to Medicare beneficiaries with whom the physician/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;

• State that a physician/practitioner who opts-out of Medicare acknowledges that, during the opt-out

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

payment may be made to any entity for the physician’s/practitioner’s services, directly or on a

capitated basis;

• State on acknowledgment by the physician/practitioner to the effect that, during the opt-out period,

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

contracts that the physician/practitioner has entered into;

• Acknowledge that the physician/practitioner recognizes that the terms of the affidavit apply to all

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

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

furnished to the beneficiaries with whom the physician/practitioner has not previously privately

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

• With respect to a physician/practitioner who has signed a Part B participation agreement,

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

• Acknowledge that the physician/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 and that the rules of §40.28 apply if the

physician/practitioner furnishes such services;

• Identify the physician/practitioner sufficiently so that the Medicare contractor can ensure that no

payment is made to the physician/practitioner during the opt-out period; and

• Be filed with all MACs who have jurisdiction over claims the physician/practitioner would otherwise

file with Medicare, and the initial 2-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 his or her first private contract with a Medicare beneficiary.

History

(Rev. 222, Issued: 05-13-16, Effective: 08-15-16, Implementation; 08-15-16)

Provenance

Source
cms.gov
Retrieved
2026-08-25
Edition
iom-2026-08-25
Content hash
40b993cd2626b0c14eab32c2ba63ee07d742672dcc6f1ae6441a4b48ddb400ff
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CMS Pub. 100-02, ch. 15, § 40.9 — Requirements of the… · binding.law