(Medicare Benefit Policy Manual)

 State that the beneficiary or the beneficiarys legal representative enters into the contract with the knowledge that the beneficiary has the right to obtain Medicare- covered items and services from physicians and practitioners who have not opted out of Medicare, and that the beneficiary is not compelled to enter into private contracts that apply to other Medicare-covered services furnished by other physicians or practitioners who have not opted out;   State the expected or known effective date and the expected or known expiration date of the current 2-year opt-out period;   State that the beneficiary or the beneficiarys legal representative understands that Medigap plans do not, and that other supplemental plans may elect not to, make payments for items and services not paid for by Medicare;   Be signed by the beneficiary or the beneficiarys legal representative and by the physician/practitioner;   Not be entered into by the beneficiary or by the beneficiarys legal representative during a time when the beneficiary requires emergency care services or urgent care services.  (However, a physician/practitioner may furnish emergency or urgent care services to a Medicare beneficiary in accordance with 40.28 );   Be provided (a photocopy is permissible) to the beneficiary or to the beneficiarys 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/practitioners 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 eac h 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 physicians or practitioners 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.  (S ee 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 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);    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;    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;   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    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.