42 CFR 422.100 - General requirements.
(a) Basic rule. Subject to the conditions and limitations set forth in this subpart, an MA organization offering an MA plan must provide enrollees in that plan with coverage of the basic benefits described in paragraph (c) of this section (and, to the extent applicable, the benefits described in § 422.102) by furnishing the benefits directly or through arrangements, or by paying for the benefits. CMS reviews these benefits subject to the requirements of § 422.100(g) and the requirements in subpart G of this part.
(b) Services of noncontracting providers and suppliers.
(1) An MA organization must make timely and reasonable payment to or on behalf of the plan enrollee for the following services obtained from a provider or supplier that does not contract with the MA organization to provide services covered by the MA plan:
(i) Ambulance services dispatched through 911 or its local equivalent as provided in § 422.113.
(ii) Emergency and urgently needed services as provided in § 422.113.
(iii) Maintenance and post-stabilization care services as provided in § 422.113.
(iv) Renal dialysis services provided while the enrollee was temporarily outside the plan's service area.
(v) Services for which coverage has been denied by the MA organization and found (upon appeal under subpart M of this part) to be services the enrollee was entitled to have furnished, or paid for, by the MA organization.
(2) An MA plan (and an MA MSA plan, after the annual deductible in § 422.103(d) has been met) offered by an MA organization satisfies paragraph (a) of this section with respect to benefits for services furnished by a noncontracting provider if that MA plan provides payment in an amount the provider would have received under original Medicare (including balance billing permitted under Medicare Part A and Part B).
(c) Types of benefits. An MA plan includes at a minimum basic benefits, and also may include mandatory and optional supplemental benefits.
(1) Basic benefits are all Medicare-covered services, except hospice services.
(2) Supplemental benefits, which consist of -
(i) Mandatory supplemental benefits are services not covered by Medicare that an MA enrollee must purchase as part of an MA plan that are paid for in full, directly by (or on behalf of) Medicare enrollees, in the form of premiums or cost-sharing.
(ii) Optional supplemental benefits are health services not covered by Medicare that are purchased at the option of the MA enrollee and paid for in full, directly by (or on behalf of) the Medicare enrollee, in the form of premiums or cost-sharing. These services may be grouped or offered individually.
(d) Availability and structure of plans. An MA organization offering an MA plan must offer it -
(1) To all Medicare beneficiaries residing in the service area of the MA plan;
(2) At a uniform premium, with uniform benefits and level of cost-sharing throughout the plan's service area, or segment of service area as provided in § 422.262(c)(2).
(e) Multiple plans in one service area. An MA organization may offer more than one MA plan in the same service area subject to the conditions and limitations set forth in this subpart for each MA plan.
(f) CMS review and approval of MA benefits and associated cost sharing. CMS reviews and approves MA benefits and associated cost sharing using written policy guidelines and requirements in this part and other CMS instructions to ensure all of the following:
(1) Medicare-covered services meet CMS fee-for-service guidelines.
(2) MA organizations are not designing benefits to discriminate against beneficiaries, promote discrimination, discourage enrollment or encourage disenrollment, steer subsets of Medicare beneficiaries to particular MA plans, or inhibit access to services. and
(3) Benefit design meets other MA program requirements.
(4) Except as provided in paragraph (f)(5), MA local plans (as defined in § 422.2) must have an out-of pocket maximum for Medicare Parts A and B services that is no greater than the annual limit set by CMS.
(5) With respect to a local PPO plan, the limit specified under paragraph (f)(4) applies only to use of network providers. Such local PPO plans must include a total catastrophic limit on beneficiary out-of-pocket expenditures for both in-network and out-of-network Parts A and B services that is -
(i) Consistent with the requirements applicable to MA regional plans at § 422.101(d)(3) of this part; and
(ii) Not greater than the annual limit set by CMS.
(6) Cost sharing for Medicare Part A and B services specified by CMS does not exceed levels annually determined by CMS to be discriminatory for such services.
(g) Benefits affecting screening mammography, influenza vaccine, and pneumoccal vaccine.
(1) Enrollees of MA organizations may directly access (through self-referral) screening mammography and influenza vaccine.
(2) MA organizations may not impose cost-sharing for influenza vaccine and pneumococcal vaccine on their MA plan enrollees.
(h) Requirements relating to Medicare conditions of participation. Basic benefits must be furnished through providers meeting the requirements in § 422.204(b)(3).
(i) Provider networks. The MA plans offered by an MA organization may share a provider network as long as each MA plan independently meets the access and availability standards described at § 422.112, as determined by CMS.
(j) Services for which cost sharing may not exceed cost sharing under Original Medicare. On an annual basis, CMS will evaluate whether there are service categories for which MA plans' in-network cost sharing may not exceed that required under Original Medicare and specify in regulation which services are subject to that cost sharing limit. The following services are subject to this limit on cost sharing:
(1) Chemotherapy administration services to include chemotherapy drugs and radiation therapy integral to the treatment regimen.
(2) Renal dialysis services as defined at section 1881(b)(14)(B) of the Act.
(3) Skilled nursing care defined as services provided during a covered stay in a skilled nursing facility during the period for which cost sharing would apply under Original Medicare.
(k) Cost sharing for in-network preventive services. MA organizations may not charge deductibles, copayments, or coinsurance for in-network Medicare-covered preventive services (as defined in § 410.152(l)).
(l) Coverage of DME. MA organizations -
(1) Must cover and ensure enrollees have access to all categories of DME covered under Part B; and
(2) May, within specific categories of DME, limit coverage to certain DME brands, items, and supplies of preferred manufacturers provided the MA organization ensures all of the following:
(i) Its contracts with DME suppliers ensure that enrollees have access to all DME brands, items, and supplies of preferred manufacturers.
(ii) Its enrollees have access to all medically-necessary DME brands, items, and supplies of non-preferred manufacturers.
(iii) At the enrollees' request, it provides for an appropriate transition process for new enrollees during the first 90 days of their coverage under its MA plan, during which time the MA organization will do the following:
(A) Ensure the provision of a transition supply of DME brands, items, and supplies of non-preferred manufacturers.
(B) Provide for the repair of DME brands, items, and supplies of non-preferred manufacturers.
(iv) It makes no negative changes to its DME brands, items, and supplies of preferred manufacturers during the plan year.
(v) It treats denials of DME brands, items, and supplies of non-preferred manufacturers as organization determinations subject to § 422.566.
(vi) It discloses DME coverage limitations and beneficiary appeal rights in the case of a denial of a DME brand, item, or supply of a non-preferred manufacturer as part of the description of benefits required under § 422.111(b)(2) and § 422.111(h).
(vii) It provides full coverage, without limitation on brand and manufacturer, to all DME categories or subcategories annually determined by CMS to require full coverage.
(m) Special requirements during a disaster or emergency.
(1) When a state of disaster is declared as described in paragraph (m)(2) of this section, an MA organization offering an MA plan must, until one of the conditions described in paragraph (m)(3) of this section occurs, ensure access to benefits in the following manner:
(i) Cover Medicare Parts A and B services and supplemental Part C plan benefits furnished at non-contracted facilities subject to § 422.204(b)(3).
(ii) Waive, in full, requirements for gatekeeper referrals where applicable.
(iii) Provide the same cost-sharing for the enrollee as if the service or benefit had been furnished at a plan-contracted facility.
(iv) Make changes that benefit the enrollee effective immediately without the 30-day notification requirement at § 422.111(d)(3).
(2) Declarations of disasters. A declaration of disaster will identify the geographic area affected by the event and may be made as one of the following:
(i) Presidential declaration of a disaster or emergency under the either of the following:
(A) Stafford Act.
(B) National Emergencies Act.
(A) Secretarial declaration of a public health emergency under section 319 of the Public Health Service Act.
(B) If the President has declared a disaster as described in paragraph (m)(2)(i) or (ii) of this section, then the Secretary may also authorize waivers or modifications under section 1135 of the Act.
(iii) Declaration by the Governor of a State or Protectorate.
(3) End of the disaster. The public health emergency or state of disaster ends when any of the following occur:
(i) The source that declared the public health emergency or state of disaster declares an end.
(ii) The CMS declares an end of the public health emergency or state of disaster.
(iii) Thirty days have elapsed since the declaration of the public health emergency or state of disaster and no end date was identified in paragraph (m)(3)(i) or (ii) of this section.
(4) MA plans unable to operate. An MA plan that cannot resume normal operations by the end of the public health emergency or state of disaster must notify CMS.
(5) Disclosure. In addition to other requirements of annual disclosure under § 422.111, an organization must do all of the following:
(i) Indicate the terms and conditions of payment during the public health emergency or disaster for non-contracted providers furnishing benefits to plan enrollees residing in the state-of-disaster area.
(ii) Annually notify enrollees of the information listed in paragraphs (m)(1) through (3) and (m)(5) of this section.
(iii) Provide the information described in paragraphs (m)(1), (2), (3), and (4)(i) of this section on its Web site.
Title 42 published on 2014-10-01
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 42 CFR Part 422 after this date.