Page 31 - Medicare Benefit Policy Manual

• Be provided (a photocopy is permissible) to the beneficiary or to the
beneficiary’s legal representative before items or services are furnished to the
beneficiary under the terms of the contract;

• Be retained (original signatures of both parties required) by the
physician/practitioner for the duration of the current 2-year opt-out period;

• Be made available to CMS upon request; and

• Be entered into for each 2-year opt-out period.

In order for a private contract with a beneficiary to be effective, the physician/practitioner
must be opted out of Medicare. The physician/practitioner’s initial 2-year opt-out period
begins the date the affidavit meeting the requirements of §40.9 is signed, provided the
affidavit is filed within 10 days after he or she signs his or her first private contract with a
Medicare beneficiary. Once the physician/practitioner has opted out, such
physician/practitioner must enter into a private contract with each Medicare beneficiary
to whom the physician/practitioner furnishes covered services (even where Medicare
payment would be on a capitated basis or where Medicare would pay an organization for
the physician’s or practitioner’s services to the Medicare beneficiary), with the exception
of a Medicare beneficiary needing emergency or urgent care. When a 2-year opt-out
period ends, the physician/practitioner must enter into new private contracts with each
beneficiary for the new 2-year period. The new private contracts must state the expected
or known effective date and the expected or known expiration date of the current 2-year
opt-out period.

If a physician/practitioner has opted out of Medicare, the physician/practitioner must use
a private contract for items and services that are, or may be, covered by Medicare (except
for emergency or urgent care services (see §40.28)). An opt-out physician/practitioner is
not required to use a private contract for an item or service that is definitely excluded
from coverage by Medicare.

A non-opt-out physician/practitioner, or other supplier, is required to submit a claim for
any item or service that is, or may be, covered by Medicare. Where an item or service
may be covered in some circumstances, but not in others, the physician/practitioner, or
other supplier, may provide an Advance Beneficiary Notice to the beneficiary, which
informs the beneficiary that Medicare may not pay for the item or service, and that if
Medicare does not do so, the beneficiary is liable for the full charge. (See §§40, 40.24.)

40.9 - Requirements of the Opt-Out Affidavit
(Rev. 222, Issued: 05-13-16, Effective: 08-15-16, Implementation; 08-15-16)

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