CMS Pub. 100-02, ch. 15, § 40.11

A. Failure to maintain opt-out

A physician/practitioner fails to maintain opt-out under this section if during the opt-out period one of the

following occurs:

• The physician/practitioner has filed an affidavit in accordance with §40.9 and has signed private

contracts in accordance with §40.8, but the physician/practitioner knowingly and willfully submits a

claim for Medicare payment (except as provided in §40.28) or the physician/practitioner receives

Medicare payment directly or indirectly for Medicare-covered services furnished to a Medicare

beneficiary (except as provided in §40.28); or

• The physician/practitioner fails to enter into private contracts with Medicare beneficiaries for the

purpose of furnishing items and services that would otherwise be covered by Medicare, or enters into

private contracts that fail to meet the specifications of §40.8; or

• The physician/practitioner fails to comply with the provisions of §40.28 regarding billing for

emergency care services or urgent care services; or

• The physician/practitioner fails to retain a copy of each private contract that the

physician/practitioner has entered into for the duration of the current 2-year period for which the

contracts are applicable or fails to permit CMS to inspect them upon request.

B. Violation discovered by the Medicare contractor during the current 2-year period.

If a physician/practitioner fails to maintain opt-out in accordance with the provisions outlined in paragraph

(A) of this section, and fails to demonstrate within 45 days of a notice from the Medicare contractor that the

physician/practitioner has taken good faith efforts to maintain opt-out (including by refunding amounts in

excess of the charge limits to the beneficiaries with whom the physician/practitioner did not sign a private

contract), the following will result effective 46 days after the date of the notice for the remainder of the

opt-out period:

1. All of the private contracts between the physician/practitioner and Medicare beneficiaries are deemed

null and void.

2. The physician’s or practitioner’s opt-out of Medicare is nullified.

3. The physician or practitioner must submit claims to Medicare for all Medicare covered items and

services furnished to Medicare beneficiaries.

4. The physician or practitioner or beneficiary will not receive Medicare payment on Medicare claims

for the remainder of the opt-out period, except as stated above.

5. The physician or practitioner is subject to the limiting charge provisions as stated in §40.10.

6. The practitioner may not reassign any claim except as provided in Pub. 100-04, Medicare Claims

Processing Manual, Chapter 1, “General Billing Requirements,” §30.2.13.

7. The practitioner may neither bill nor collect any amount from the beneficiary except for applicable

deductible and coinsurance amounts.

8. The physician or practitioner may not attempt to once more meet the criteria for properly opting out

until the current 2-year period expires.

C. Violation not discovered by the Medicare contractor during the current 2-year period.

• In situations where a violation of paragraph (A) of this section is not discovered by the Medicare

contractor during the 2-year period when the violation actually occurred, the requirements of

paragraphs (B)(1) through (B)(8) of this section are applicable from the date that the first violation

of paragraph (A) of this section occurred until the end of the 2-year period during which the

violation occurred (unless the physician or practitioner takes good faith efforts, within 45 days of

any notice from the Medicare contractor that the physician or practitioner failed to maintain opt-out,

or within 45 days of the physician’s or practitioner’s discovery of the failure to maintain opt-out,

whichever is earlier, to correct his or her violations of paragraph (A) of this section. Good faith

efforts include, but are not necessarily limited to, refunding any amounts collected in excess of the

charge limits from beneficiaries with whom he or she did not sign a private contract).