(Medicare Benefit Policy Manual)

 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 r equest.   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 fa ith 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 not ice 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 physicians or practitioners 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 physicians or practitioners 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).   40.12 - Actions to Take in Cases of Failure to Maintain Opt -Out  (Rev. 222, Issued: 05-13-16, Effective: 08-15-16, Implementation; 08-15-16)  If the Medicare contractor becomes aware that the physician/practitioner has failed to maintain opt -out as indicated in 40.11, it must send the physician/practitioner a letter advising the physician/practitioner that it has received a claim and believes that the physician/ practitioner may have inadvertently failed to maintain opt-out.  It must describe the situation in 40.11 that it believes exists and its basis for its belief.  It must ask the physician or practitioner to provide it with an explanation of what happened and how, within 45 days, the physician or practitioner will resolve it.  (See Pub. 100-04, Medicare Claims Processing Manual, Chapter 1, General Billing Requirements, 70.6).  If the Medicare contractor received a claim from the opt -out physician/practitioner, it must ask the physician/practitioner if the received claim was: (a) an emergency or urgent situation, with missing documentation, or  (b) filed in error.  When the reason for the letter is that the physician/practitioner filed a claim that the physician/practitioner did not identify as an emergency or urgent care service, the Medicare contractor must request that the physician/practitio ner submit the following information with the physicians/practitioners response:   Emergency/urgent care documentation if the claim was for a service furnished in an emergency or urgent situation but included no documentation to that effect; and/or   If the claim was filed in error, the Medicare contractor must ask the physician/practitioner to explain whether the filing was an isolated incident or a systematic problem affecting a number of claims.   In the case of any potential failure to maintain opt-out (including but not limited to improper submission of a claim), the Medicare contractor must explain in its request to the physician or practitioner that it would like to resolve this matter as soon as possible.  It must instruct the physician/practitioner to provide the information it requested within 45 days of the date of its development letter.  It must provide the physician or practitioner with the name and telephone number of a contact person in case they have any questions.   If the violation was due to a systems problem, the Medicare contractor must ask the physician or practitioner to include with his or her response an explanation of the actions being taken to correct the problem and when the physician or practitioner expects the system error to be fixed.  If the violation persists beyond the time period indicated in the physicians or practitioners response, the Medicare contractor must contact the physician or practitioner again to ascertain why the problem still exists an d when the physician or practitioner expects to have it corrected.  It must repeat this process until the system problem is corrected.   Also, in the Medicare contractors development request, it must advise the physician or practitioner that if no response is received by the due date, the Medicare contractor will assume that there has been no correction of the failure to maintain opt-out a nd that this could result in a determination that the physician/practitioner is once again subject to Medicare rules.   In the case of wrongly filed claims, the Medicare contractor must hold the claim and any others it receives from the physician or practitioner in suspense until it hears from the physician or practitioner or the response date lapses.  In this case, if the physician or practitioner responds that the claim was filed in error, the Medicare contractor must continue processing the claim, deny the claim, and send the physician or practitioner the appropriate Remittance Advice and send the beneficiary a Medicare S ummary Notice (MSN) with the appropriate language explaining that the claim was submitted erroneously and the beneficiary is responsible for the physicians or practitioners charge.  In other words, the limiting charge provision does not apply and the beneficiary is responsible for all charges.  This process will apply to all claims until the physician or practitioner is able to get the problem fixed.  If the Medicare contractor does not receive a response from the physician or practitioner by the development letter due date or if it is determined that the opt-out physician or practitioner knowingly and willfully failed to maintain opt-out, it must notify the physician or practitioner that the effects of failure to maintain opt-out specified in 40.11 apply.  It must formally notify the physician/practitioner of this determination and  of the rules that again apply (e.g., mandatory submission of claims, limiting charge, etc.) .  It must specifically include in this letter each of the effects of failing to opt-out that are identified in 40.11.  The act of claims submission by the beneficiary for an item or service provided by a physician or practitioner who has opted out is not  a violation by the physician or practitioner and does not nullify the contract with the beneficiary.  However, if there are what the Medicare contractor considers to be a substantial number of claims submissions by beneficiaries for items or services by an opt-out physician or practitioner, it must investigate to ensure that contracts between the physician or practitioner and the beneficiaries exist and that the terms of the contracts meet the Medicare statutory requirements outlined in this instruction.  If noncompliance with the opt- out affidavit is determined, it must develop claims submission or limiting charge violation cases, as appropriate, based on its findings.  In cases in which the beneficiary files an appeal of the denial of a beneficiary -filed claim for services from an opt-out physician or practitioner, and alleges that there was no private contract, the Medicare contractor must ask the physician/practitioner to provide it with a copy of the private contract.  Where the physician or practitioner does not provide a copy of a private contract that meets the requirements of 40.8 and was signed by the beneficiary before the service was furnished, the Medicare contractor must make payment to the beneficiary and proceed as described above.   40.13 - Physician/Practitioner Who Has Never Enrolled in Medicare  (Rev. 222, Issued: 05-13-16, Effective: 08-15-16, Implementation; 08-15-16)  For a physician/practitioner who has never enrolled in the Medicare program and wishes to opt-out of Medicare, if the physician/practitioner does not have an NPI, then the physician/practitioner must include his or her TIN on the opt-out affidavit.  The Me dicare contractor must annotate its in -house provider file that the physician/practitioner has opted out of the program.  The Medicare contractor can get the full name, address, license number, and tax identification number from the physicians/practitione rs opt -out affidavit.  All other data requirements should be developed from other data sources (e.g., the American Medical Association, State Licensing Board, etc.).  The physician/practitioner must not receive payment during the opt-out period (except in  the case of emergency or urgent care services).  If the Medicare contractor needs additional data elements and cannot obtain that information from another source, it may contact the physician/practitioner directly.  It must notify the physician or practit ioner that in order to certify or order services for a Medicare patient, the physician or practitioner must have a valid NPI.  If an opt-out physician/practitioner provides emergency or urgent care service to a beneficiary who has not signed a private contract with the physician or practitioner and the physician/practitioner submits an assigned claim, the physician or practitioner must complete Form CMS -855-I and enroll in the Medicare program before receiving reimbursement.  Under a similar circumstance, if the physician or practitioner submits an unassigned claim, the Medicare contractor must pay the beneficiary directly without requiring a completed Form CMS-855-I.  It may use the information from the affidavit to begin the enrollment process.  40.14 - Nonparticipating Physicians or Practitioners Who Opt Out of Medicare  (Rev. 222, Issued: 05-13-16, Effective: 08-15-16, Implementation; 08-15-16)  A nonparticipating physician or practitioner may opt- out of Medicare at any time in accordance with the following:   The 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 the physician or practitioner signs his or her first private contract with a Medicare beneficiary.    If the physician or practitioner does not timely file any required affidavit, the initial 2-year opt-out period begins when the last such affidavit is filed.  Any private contract entered into before the last required affidavit is filed becomes effective u pon the filing of the last required affidavit and the furnishing of any items or services to a Medicare beneficiary under such contract before the last required affidavit is filed is subject to standard Medicare rules.   40.15 - Excluded Physicians and Practitioners  (Rev. 160, Issued: 10-26-12, Effective: 01-28-13, Implementation: 01-28-13)  An excluded physician or practitioner may opt out of Medicare by submitting the required documentation in accordance with 40.9 .  When determining effective dates of the exclusion versus the opt-out, the date of exclusion always takes precedence over the date the physician or practitioner opts out of Medicare.  A physician or practitioner who has been excluded must comply with 42 CFR 1001.1901 , Scope and Effect of Exclusion.  If an excluded/opt- out physician or practitioner submits a claim to Medicare, the Medicare contractor must not make payment for services furnished, ordered, or prescribed on or after the effective date of the exclusion, except in the limited circumstances stated in 42 CFR 1001.1901.  The Medicare contractor must not make payment to a beneficiary who submits claims for services rendered by an excluded/opt-out physician or practitioner (except where payment would otherwise be made in accordance with the Medicare Program Integrity Manual) .  It must deny the claim and send the physician or practitioner the appropriate remittance and send the beneficiary a MSN as explained in 40.39.