evekhm/cms_iom_500 huggingface dataset:
(Medicare Benefit Policy Manual)
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 autom atic 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 physicians or practitioners full name, address, telephone number, NPI or billing number (if one has been assigned), or, if an NPI has not been assigned, the physicians or practitioners tax identification number (TIN);
(Medicare Benefit Policy Manual)
 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 Medi care- 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 physicians/practitioners 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 th e 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 physicians/practitioners services are not covered under Medicare and that no Medicare payment may be made to any entity for the physicians/practitioners 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 u rgent 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;
(Medicare Benefit Policy Manual)
 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.  40.10 - Failure to Properly Opt Out  (Rev. 222, Issued: 05-13-16, Effective: 08-15-16, Implementation; 08-15-16)  A.  A physician/practitioner fails to properly opt-out for any of the following reasons:   Any private contract between the physician/practitioner and a Medicare beneficiary that was entered into before the affidavit described in 40.9 was filed does not meet the specifications of 40.8; or    The physician/practitioner fails to submit the affidavit(s) in accordance with 40.9.  B.  If a physician/practitioner fails to properly opt-out in accordance with the above paragraphs of this section, the following will result:    The physicians or practitioners attempt to opt-out of Medicare is nullified, and all of the private contracts between the physician/practitioner and Medicare beneficiaries for the 2 year period covered by the attempted opt-out are deemed null and void;
(Medicare Benefit Policy Manual)
 The physician/practitioner must submit claims to Medicare for all Medicare -covered items and services furnished to Medicare beneficiaries, including the items and services furnished under the nullified contracts.  A nonparticipating physician/practitioner is subject to the limiting charge provision.  For items or services paid under the physician fee schedule, the limiting charge is 115 percent of the approved amount for nonparticipating physicians or practitioners.  A participating physician/practitioner i s subject to the limitations on charges of the participation agreement the physician/practitioner signed;   The physician/practitioner may not reassign any claim except as provided in the Medicare Claims Processing Manual, Chapter 1, General Billing Requirements, 30.2.12 and 30.2.13;   The physician/practitioner may neither bill nor collect an amount from the beneficiary except for applicable deductible and coinsurance amounts; and   The physician/practitioner may make another attempt to properly opt- out at any time.   40.11 - Failure to Maintain Opt -Out (Rev. 222, Issued: 05-13-16, Effective: 08-15-16, Implementation; 08-15-16)  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
(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.
(Medicare Benefit Policy Manual)
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).
(Medicare Benefit Policy Manual)
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.
(Medicare Benefit Policy Manual)
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.
(Medicare Benefit Policy Manual)
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.
(Medicare Benefit Policy Manual)
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.
(Medicare Benefit Policy Manual)
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.