42 U.S.C. § 1395w–22 — Benefits and beneficiary protections
submitted 91 years ago by Pub. L. 105-33 to r/title-42-THE-PUBLIC-HEALTH-AND-WELFARE · 8,894 words · no verdicts yet
This section requires Medicare+Choice and Medicare Advantage plans to provide specified Medicare benefits and sets rules for supplemental benefits, cost-sharing, access, disclosures, quality improvement, grievances, coverage decisions, appeals, records, provider relationships, and provider payment limits. It also permits specified telehealth and chronic-illness benefits and requires information about safely disposing of certain prescription drugs.
(a) Basic benefits
(1) Requirement.
(A) In general. Except for the rule in section 1395w–28(b)(3) for MSA plans and paragraph (6) for MA regional plans, every Medicare+Choice plan* must provide its enrolled members the benefits available under the original Medicare fee-for-service program option. The plan must use providers and other persons that meet the applicable requirements of this subchapter and part A of subchapter XI. For plan years before 2006, the plan must also provide the additional benefits required by section 1395w–24(f)(1)(A).
(B) Meaning of “benefits under the original Medicare fee-for-service program option.”
(i) In general. For this part, this quoted term means, subject to subsection (m), the items and services for which parts A and B provide benefits to people entitled to part A and enrolled in part B. It does not include hospice care* or coverage for acquiring organs for kidney transplants, including coverage under section 1395rr(d). Cost-sharing* must be the amount required under parts A and B, or, subject to clause (iii), an actuarially equivalent amount determined under this part.
(ii) Special rule for regional plans. For an MA regional plan*, when an actuarially equivalent cost-sharing level is calculated for these benefits, the calculation may count, for purposes of section 1395w–27a(b)(2), only expenses described in subparagraph (A) of that section.
(iii) Limit on changing cost-sharing for certain benefits. Subject to clause (v), cost-sharing for the services in clause (iv) may not be higher than the cost-sharing required for those services under parts A and B.
(iv) Services covered by this limit. They are: (I) chemotherapy administration*; (II) renal dialysis services, as defined in section 1395rr(b)(14)(B); (III) skilled nursing care; (IV) a clinical diagnostic laboratory test given during any part of the emergency period defined in section 1320b–5(g)(1)(B) that begins on or after March 18, 2020, when the test detects SARS–CoV–2 or diagnoses the virus that causes COVID–19, and the administration of that test; (V) specified COVID–19 testing-related services described in section 1395l(cc)(1) for which payment would be made under a specified outpatient payment provision described in section 1395l(cc)(2); (VI) a COVID–19 vaccine and its administration described in section 1395x(s)(10)(A); (VII) a drug* or biological product that is a selected drug referred to in section 1320f–1(c); and (VIII) other services the Secretary* considers appropriate, including services the Secretary determines need especially predictable and transparent costs for beneficiaries.
(v) Exception. For a service in clause (iv), other than subclauses (IV), (V), and (VI), if parts A and B require no cost-sharing for that service, the plan may require cost-sharing under clause (i).
(vi) No prior authorization for certain COVID–19 testing. During any part of the emergency period described in subclause (IV) or (V) that begins on or after March 18, 2020, an MA plan may not impose prior authorization or another utilization-management requirement on coverage of a product or service described in that subclause.
(2) When the requirement is satisfied.
(A) In general. A Medicare+Choice plan, other than an MSA plan*, offered by a Medicare+Choice organization* satisfies paragraph (1)(A) for items and services furnished by a provider or other person* without a contract with the organization if the plan pays enough that the payment plus any plan cost-sharing is at least the total dollar amount that parts A and B would otherwise authorize for those items and services, including any balance billing that those parts permit.
(B) Related provisions. Limits on balance billing a Medicare+Choice organization for noncontract providers appear in subsection (k) and section 1395cc(a)(1)(O). The limit on the actuarial value of an enrollee’s liability for covered benefits appears in section 1395w–24(e).
(C) One coverage determination for an area. If different parts of the area served by a Medicare+Choice plan use more than one local coverage determination, the organization may choose the determination that the Secretary identifies as most beneficial to Medicare+Choice enrollees in one part of the area and apply it to every enrollee in the plan.
(3) Supplemental benefits.
(A) Included benefits needing Secretary approval. Subject to subparagraph (D), a Medicare+Choice organization may provide approved supplemental health care benefits to people enrolled under this part, except people enrolled under an MSA plan, without giving them a choice to decline that coverage. The Secretary must approve the benefits unless the Secretary decides that including them would substantially discourage Medicare+Choice-eligible people from enrolling with the organization.
(B) Benefits chosen by enrollees.
(i) In general. Subject to clause (ii), the organization may offer supplemental health care benefits that an enrollee may choose to have covered.
(ii) MSA plans. An organization may not use an MSA plan to offer supplemental benefits that cover the deductible described in section 1395w–28(b)(2)(B). Health benefits described in section 1395ss(u)(2)(B) are not treated as covering that deductible for this rule.
(C) Private fee-for-service plans. This paragraph does not stop a Medicare+Choice private fee-for-service plan* from offering supplemental benefits that pay some or all balance-billing amounts allowed consistently with subsection (k), or that cover additional services the plan finds medically necessary. Those benefits may reduce cost-sharing below the actuarial value specified in section 1395w–24(e)(4)(B).
(D) Benefits for chronically ill enrollees.
(i) In general. For plan year 2020 and later, in addition to other supplemental benefits under this paragraph, an MA plan, including a specialized MA plan for special-needs individuals as defined in section 1395w–28(b)(6), may provide the benefits in clause (ii) to a chronically ill enrollee as defined in clause (iii).
(ii) Benefits described.
(I) In general. These are supplemental benefits that can reasonably be expected to improve or maintain the chronically ill enrollee’s health or overall ability to function. They do not have to be mainly health-related benefits.
(II) Waiver of uniformity. For supplemental benefits provided under this subparagraph to a chronically ill enrollee, the Secretary may waive this part’s uniformity requirements when the Secretary considers that appropriate.
(iii) Meaning of “chronically ill enrollee.” This quoted term means an MA-plan enrollee whom the Secretary determines: (I) has one or more comorbid and medically complex chronic conditions that threaten life or substantially limit overall health or function; (II) faces a high risk of hospitalization* or other harmful health outcomes; and (III) needs intensive coordination of care.
(4) Organization as secondary payer. When payment under this subchapter is secondary under section 1395y(b)(2), a Medicare+Choice organization may charge, or authorize the service provider to charge, under the charges allowed by the law, plan, or policy described in that section: (A) the insurance carrier, employer, or other entity that must pay for the services under that law, plan, or policy; or (B) the individual, to the extent that the individual has been paid under that law, plan, or policy for the services.
(5) National coverage decisions and legislative benefit changes. Suppose a national coverage determination or a legislative change to benefits required under this part is made between the date of one announcement under section 1395w–23(b) and the date of the next announcement. If the Secretary projects that it will significantly change the organization’s cost of providing the affected benefits, and that cost change was not included in the annual capitation-rate calculation announced at the beginning of that period, then, unless another law requires otherwise: (A) the decision or change does not apply to contracts under this part until the first contract year beginning after that period ends; and (B) if it adds benefits or adds circumstances in which benefits are covered, section 1395w–21(i)(1) does not apply to payment for those added benefits or circumstances until that first contract year. The projection must be based on an analysis by the Chief Actuary of the Centers for Medicare & Medicaid Services of the actuarial costs of the decision or change.
(6) Regional-plan benefits. An MA regional plan must include the benefits described in section 1395w–27a(b)(1) and (2).
(7) Cost-sharing for certain dual-eligible people and qualified Medicare beneficiaries. For a full-benefit dual-eligible individual, as defined in section 1396u–5(c)(6), or a qualified Medicare beneficiary, as defined in section 1396d(p)(1), who is enrolled in the specialized Medicare Advantage plan for special-needs individuals described in section 1395w–28(b)(6)(B)(ii), the plan may not charge more cost-sharing than subchapter XIX would allow if the person were not enrolled in that plan.
(b) Antidiscrimination.
(1) Beneficiaries. A Medicare Advantage organization may not deny, limit, or condition coverage or benefits under this part for a person allowed to enroll based on a health-status factor described in section 2702(a)(1) of the Public Health Service Act. The Secretary may not approve an organization’s plan if the Secretary decides that its design and benefits are likely to substantially discourage certain MA-eligible people from enrolling with the organization.
(2) Providers. A Medicare+Choice organization may not discriminate in participation, payment, or indemnification against a provider who acts within the scope of the provider’s license or certification under State* law solely because of that license or certification. This does not stop a plan from including only the providers needed to meet enrollees’ needs or from using measures that maintain quality and control costs consistently with the plan’s responsibilities.
(c) Disclosure requirements.
(1) Detailed plan description. At enrollment and at least once a year afterward, a Medicare+Choice organization must give each enrollee a clear, accurate, standardized description of the plan. It must include: (A) the service area; (B) benefits, including the information described in section 1395w–21(d)(3)(A), coverage exclusions, and, for an MSA plan, a comparison with benefits under other Medicare+Choice plans; (C) the number, types, and locations of providers, any out-of-network coverage, any point-of-service option and its supplemental premium, and, for a specified MA plan in plan year 2028 and later, the provider-directory information required by paragraph (3)(B); (D) out-of-area coverage; (E) emergency-service coverage, including proper use of emergency services and 911 or its local equivalent, what counts as an emergency, how to obtain emergency services, and the locations of emergency departments and other settings where plan physicians and hospitals provide emergency and post-stabilization care; (F) available supplemental benefits, including whether they are optional, what they cover, and the monthly supplemental beneficiary premium; (G) prior-authorization and other review rules that could result in nonpayment; (H) all grievance and appeal rights and procedures; and (I) a description of the quality-improvement program under subsection (e).
(2) Information on request. When a Medicare+Choice-eligible person asks, the organization must provide: (A) the general coverage and comparative-plan information made available under section 1395w–21(d)(2)(A)(i) and (ii); (B) information about procedures used to control service use and spending; (C) the number of grievances, redeterminations, and appeals and their overall outcomes; and (D) a general summary of how participating physicians are paid.
(3) Accurate provider directories.
(A) In general. For plan year 2028 and later, every MA organization offering a specified MA plan must, for each such plan: (i) keep an accurate provider directory on a publicly available website, containing the information in subparagraph (B); (ii) verify each listed provider’s information at least every 90 days and update it when needed, except that the Secretary may set a less frequent schedule for a hospital or other appropriate facility, but never less often than once every 12 months; (iii) mark information that the organization cannot verify as possibly out of date; and (iv) remove a provider within 5 business days after determining that the provider no longer participates in the plan’s network.
(B) Directory information. The directory must contain information an enrollee may need to obtain covered benefits from a provider that has an agreement with the plan, such as the provider’s name, specialty, contact information, main office or facility addresses, whether the provider accepts new patients, disability accommodations, cultural and language capabilities, and telehealth capabilities.
(C) Meaning of “specified MA plan.” This quoted term means (i) a network-based plan as defined in subsection (d)(5)(C), or (ii) a Medicare Advantage private fee-for-service plan as defined in section 1395w–28(b)(2) that meets subsection (d)(4)’s access standards, entirely or partly by entering into contracts or agreements under subparagraph (B) of that subsection.
(d) Access to services.
(1) In general. A Medicare+Choice organization may choose the providers who furnish a plan’s benefits if: (A) it makes the benefits available and accessible to each person who chooses the plan within the service area promptly enough and in a way that keeps care continuous; (B) when medically necessary, it makes the benefits available and accessible 24 hours a day, 7 days a week; (C) the plan pays for covered services furnished outside the organization when: (i) they were not emergency services, but were medically necessary and immediately needed because of an unforeseen illness, injury, or condition, and it was not reasonable in the circumstances to obtain them through the organization; (ii) they were renal dialysis services received outside the organization because the person was temporarily outside the service area; (iii) they were maintenance care or post-stabilization care covered by the guidelines under paragraph (2); or (iv) in plan year 2028 and later, for a specified MA plan, they were furnished by a provider outside the network but listed in the plan directory when the appointment was made, as described in paragraph (7)(A); (D) it gives access to appropriate providers, including credentialed specialists, for medically necessary treatment* and services; and (E) it covers emergency services without regard to prior authorization or the emergency provider’s contract with the organization.
(2) Guidelines for coordinating post-stabilization care. A Medicare+Choice plan must follow guidelines the Secretary prescribes to promote efficient and timely coordination of appropriate maintenance and post-stabilization care after the enrollee has been found stable under section 1395dd.
(3) Meaning of “emergency services.”
(A) In general. For an enrollee, this quoted term means covered inpatient and outpatient services that (i) are furnished by a provider qualified under this subchapter to furnish them and (ii) are needed to evaluate or stabilize an emergency medical condition described in subparagraph (B).
(B) Emergency medical condition based on a prudent layperson. This quoted term means a condition with acute symptoms of enough severity, including severe pain, that a prudent layperson with average health and medical knowledge could reasonably expect that failing to get immediate medical attention would: (i) put the person’s health, or a pregnant woman’s health or unborn child’s health, in serious danger; (ii) seriously harm bodily functions; or (iii) seriously impair an organ or body part.
(4) Access in private fee-for-service plans. In addition to other requirements, a Medicare+Choice private fee-for-service plan’s organization must show the Secretary that enough health care professionals and providers, with a sufficient range of types, are willing to provide services under the plan’s terms. Subject to paragraphs (5) and (6), the Secretary must find this requirement met for a provider category if either: (A) the plan’s payment rates for covered services from that category are at least the rates provided under part A, part B, or both; or (B) the plan has contracts or agreements, other than deemed contracts under subsection (j)(6), with enough providers in that category and enough types of providers to meet paragraph (1)(A) through (E), or uses both methods. This rule does not restrict the people from whom enrollees may obtain covered benefits. However, if the plan meets the entire requirement for a category through subparagraph (B), it may charge a higher copayment for providers in that category who lack such contracts or agreements.
(5) Certain nonemployer private fee-for-service plans must use provider contracts.
(A) In general. For plan year 2011 and later, a Medicare Advantage private fee-for-service plan that is not described in section 1395w–27(i)(1) or (2) and operates in a network area must meet paragraph (4)’s access standards in that area only through written contracts under paragraph (4)(B). It may not meet them, in whole or part, by setting rates that satisfy paragraph (4)(A).
(B) Network area. For a plan year, this quoted term means an area that the Secretary identifies in the announcement of proposed payment rates for the previous year under section 1395w–23(b)(1)(B) as having at least two network-based plans with enrollment under this part on the first day of the year in which the announcement is made.
(C) Network-based plan.
(i) In general. This quoted term means (I) a Medicare Advantage coordinated-care plan described in section 1395w–21(a)(2)(A)(i), except as provided in clause (ii); (II) a network-based MSA plan; or (III) a reasonable-cost reimbursement plan under section 1395mm.
(ii) Non-network regional PPOs excluded. The term does not include an MA regional plan that meets access-adequacy standards in the area mainly through the authority of 42 CFR 422.112(a)(1)(ii), rather than through written contracts.
(6) All employer private fee-for-service plans must use provider contracts. For plan year 2011 and later, a Medicare Advantage private fee-for-service plan described in section 1395w–27(i)(1) or (2) must meet paragraph (4)’s access standards only through written contracts under paragraph (4)(B), and not through rate-setting under paragraph (4)(A).
(7) Cost-sharing when directory information is wrong.
(A) In general. For plan year 2028 and later, if an enrollee in a specified MA plan receives an item or service from an out-of-network provider who was listed in the plan directory when the appointment was made, and the item or service would otherwise be covered if provided in-network, the organization must ensure that the enrollee pays no more than the lesser of: (i) the cost-sharing that would apply if the provider were in-network; or (ii) the cost-sharing that would otherwise apply without this paragraph.
(B) Notice. For plan year 2028 and later, each MA organization offering a specified MA plan must: (i) notify enrollees about these protections, to the extent practicable no later than the first day of the annual coordinated election period for the year; (ii) put information about the protections in each specified plan’s provider directory; and (iii) include notice of the protections in the first explanation of benefits issued during the plan year.
(e) Quality-improvement program.
(1) In general. Every MA organization must maintain an ongoing quality-improvement program to improve the quality of care provided to enrollees in each plan it offers.
(2) Chronic-care improvement programs. As part of that program, every MA organization must have a chronic-care improvement program. The program must have a method for monitoring and identifying enrollees with multiple or sufficiently severe chronic conditions that meet the organization’s participation criteria.
(3) Data.
(A) Collection, analysis, and reporting.
(i) In general. Subject to subparagraph (B) and the special rules in clauses (ii) and (iii), each MA organization must collect, analyze, and report data that measures health outcomes and other quality measures. For MA private fee-for-service and MSA plans, these requirements may not be greater than the requirements for MA local preferred-provider-organization plans, except that for plan year 2010 the limitation in clause (iii) does not apply and the requirements apply only to administrative claims data.
(ii) Special-needs plans. In addition to the data required by clause (i), and despite subparagraph (B)’s limits, an organization offering a specialized MA plan for special-needs individuals must collect, analyze, and report plan-level data measuring health outcomes and other quality measures related to subsection (f)(2) through (5). The data may be based on claims data.
(iii) Local PPOs and regional plans. Clause (i) applies to local MA preferred-provider-organization plans and MA regional plans only for services furnished by providers, physicians, practitioners, and suppliers that have contracts with the organization to furnish services under those plans.
(iv) Meaning of “preferred provider organization plan.” This quoted term means an MA plan that (I) has a provider network whose members agreed by contract to specified reimbursement for covered benefits; (II) pays for all covered benefits whether or not they are provided in that network; and (III) is offered by an organization not licensed or organized under State law as a health maintenance organization.
(B) Limits.
(i) Types of data. For consumer choice and program administration, the Secretary may not collect quality, outcome, and beneficiary-satisfaction data other than the types the Secretary collected as of November 1, 2003.
(ii) Changes in data types. Subject to clause (iii), the Secretary may change the types of data required under subparagraph (A) only after giving Congress a report explaining the reasons, prepared in consultation with MA organizations and private accrediting bodies.
(iii) Construction. This paragraph does not restrict the Secretary’s ability to perform the duties under section 1395w–21(d)(4)(D).
(4) Accreditation.
(A) In general. The Secretary must treat a Medicare+Choice organization as meeting all requirements in a particular clause of subparagraph (B) if a private accrediting organization has accredited and periodically reaccredited it under a process that the Secretary has found ensures that the accreditor applies and enforces standards meeting or exceeding the standards established under section 1395w–26 for that clause.
(B) Requirements covered. The clauses are: (i) paragraphs (1) through (3) of this subsection; (ii) subsection (b); (iii) subsection (d); (iv) subsection (h); (v) subsection (i); (vi) subsection (j); and (vii) the requirements in section 1395w–104(j), to the extent they apply under section 1395w–131(c).
(C) Timely application decisions. Within 210 days after receiving a private accrediting organization’s application, and using section 1395bb(a)(2)’s criteria, the Secretary must decide whether the accreditor’s process meets the requirements for each requested clause of subparagraph (B). The Secretary may not deny the application merely because it seeks approval for one clause or for more than one clause.
(D) Construction. This paragraph does not limit the Secretary’s authority under section 1395w–27, including the authority under subsection (c)(2) of that section to terminate contracts with Medicare+Choice organizations.
(f) Grievance mechanism. Each Medicare+Choice organization must provide meaningful procedures to hear and resolve grievances between the organization, including an entity or person through which it provides health care, and its Medicare+Choice enrollees.
(g) Coverage determinations, reconsiderations, and appeals.
(1) Organization determinations.
(A) In general. The organization must have a procedure for deciding whether an enrollee is entitled to receive a health service under this section and how much, if anything, the enrollee must pay. Subject to paragraph (3), the procedure must make decisions promptly.
(B) Explanation. A decision that denies coverage in whole or part must be written in understandable language. It must state why coverage was denied and explain the reconsideration and appeal processes.
(2) Reconsiderations.
(A) In general. At the enrollee’s request, the organization must reconsider a denial under paragraph (1)(B). It must do so within the time set by the Secretary and, subject to paragraph (3), no later than 60 days after receiving the request.
(B) Physician* review. If the denial was based on lack of medical necessity, the reconsideration must be made by a physician with suitable expertise in the relevant field, and that physician may not have participated in the initial decision.
(3) Expedited decisions and reconsiderations.
(A) Requests.
(i) Enrollee requests. An enrollee may request an expedited organization decision or reconsideration orally or in writing.
(ii) Physician requests. A physician, whether or not affiliated with the organization, may also make either request orally or in writing.
(B) Organization procedures.
(i) In general. The organization must maintain procedures to speed up a decision or reconsideration when, at an enrollee’s request, it determines that using the normal time could seriously endanger the enrollee’s life or health or the enrollee’s ability to regain maximum function.
(ii) Physician requests. If a physician’s request says that the normal time could have that serious effect, the organization must expedite the decision or reconsideration.
(iii) Timely response. In cases under clauses (i) and (ii), the organization must notify the enrollee and, when appropriate, the physician of the decision or reconsideration within the Secretary’s time limit. It may not take more than 72 hours after receiving the request, or the information needed to decide, unless the Secretary permits a longer time for specified cases.
(4) Independent review. The Secretary must contract with an independent outside entity to timely review and resolve reconsiderations that uphold a complete or partial denial. Section 1395ff(c)(5) applies to those contracted entities.
(5) Appeals. An enrollee who is dissatisfied because the enrollee did not receive a health service the enrollee believes was covered, at no greater charge than the enrollee believes was required, may receive a hearing before the Secretary if at least $100 is in dispute. The hearing is available to the same extent as under section 405(b), and the Secretary must make the organization a party. If at least $1,000 is in dispute, the individual or organization may, after notifying the other party, seek judicial review of the Secretary’s final decision under section 405(g). Both may be parties to that review. In applying sections 405(b), 405(g), and 405(l) under this paragraph, references to the Social Security Commissioner or Administration mean the Secretary or the Department of Health and Human Services. The rule in section 1395ff(b)(1)(E)(iii) applies to the dollar amounts in the first two sentences in the same way it applies to the amount in section 1395ff(b)(1)(E)(i).
(h) Confidentiality and accuracy of enrollee records. When a Medicare+Choice organization keeps medical records or other health information about enrollees, it must establish procedures: (1) to protect the privacy of individually identifiable enrollee information; (2) to keep the records and information accurate and current; and (3) to give enrollees timely access to them.
(i) Advance directives. Each Medicare+Choice organization must meet section 1395cc(f)’s requirement to maintain written policies and procedures concerning advance directives.
(j) Provider participation rules.
(1) Procedures. If an organization offers plan benefits through agreements with physicians, it must establish reasonable procedures for physicians’ participation under those agreements. The procedures must include: (A) notice of participation rules; (B) written notice to a physician of an adverse participation decision; and (C) an internal appeal process for such a decision, including the physician’s opportunity to present information and views.
(2) Consultation on medical policies. The organization must consult physicians who have participation agreements with it about its medical policies, quality procedures, and medical-management procedures.
(3) No interference with provider advice.
(A) In general. Subject to subparagraphs (B) and (C), a Medicare+Choice organization may not prohibit or restrict a covered health care professional from advising the professional’s patient who is enrolled in the organization’s plan about the patient’s health, medical care*, or treatment for a condition or disease. This applies whether or not the plan covers that care or treatment, as long as the professional acts within the lawful scope of practice.
(B) Conscience protection. Subparagraph (A) does not require a plan to provide, pay for, or cover counseling or referral services if the organization offering it: (i) objects to the service on moral or religious grounds; and (ii) before or during enrollment gives prospective enrollees, and within 90 days after a policy change gives enrollees, information about its policy on the service in the form and manner it considers appropriate.
(C) Construction. Subparagraph (B) does not affect disclosure duties under State law or the Employee Retirement Income Security Act of 1974.
(D) Meaning of “health care professional.” For this paragraph, this quoted term means a physician as defined in section 1395x(r), or another health care professional whose services the Medicare+Choice plan covers. It includes a podiatrist, optometrist, chiropractor, psychologist, dentist, physician assistant, physical or occupational therapist or therapy assistant, speech-language pathologist, audiologist, registered or licensed practical nurse (including a nurse practitioner*, clinical nurse specialist*, certified registered nurse anesthetist*, or certified nurse-midwife), licensed certified social worker, registered respiratory therapist, and certified respiratory therapy technician.
(4) Physician incentive plans.
(A) In general. An organization may not operate a physician incentive plan unless it gives the Secretary satisfactory assurances that: (i) the plan makes no direct or indirect specific payment to a physician or physician group to induce the physician or group to reduce or limit medically necessary services for a particular enrollee; and (ii) if the plan puts a physician or group at substantial financial risk, as the Secretary determines, for services that the physician or group does not provide, the organization gives adequate and appropriate stop-loss protection based on standards developed by the Secretary. Those standards must consider the number of physicians placed at substantial risk in the group or plan and the number of organization enrollees who receive services from them.
(B) Meaning of “physician incentive plan.” This quoted term means any payment arrangement between a Medicare+Choice organization and a physician or physician group that may directly or indirectly reduce or limit services for people enrolled under this part.
(5) No provider indemnification. An organization may not directly or indirectly require a health care professional, provider of services, other health care entity, or group of them to indemnify the organization against liability from a civil action for damage caused to an enrollee by the organization’s denial of medically necessary care.
(6) Private fee-for-service plans. For applying this part, including subsection (k)(1), and section 1395cc(a)(1)(O), a hospital or other provider, physician or other professional, or other health care entity is treated as having an agreement or contract with the organization for a person enrolled in its private fee-for-service plan if: (A) the provider, professional, or entity furnishes the enrollee services covered by the plan; and (B) before furnishing them, it has been told that the person is enrolled and either (i) has been told the plan’s payment terms or (ii) has a reasonable opportunity to obtain those terms in a way reasonably designed to produce informed agreement. This deemed agreement applies only when there is no explicit agreement between the provider or entity and the organization.
(7) Electronic prescribing by MA plans.
(A) In general. An MA–PD plan may make a separate or different payment to a participating physician who prescribes covered part D drugs through an electronic prescription drug program meeting section 1395w–104(e)’s standards.
(B) Factors. The payment may reflect the physician’s cost of implementing the program. It may also be increased for a participating physician who significantly improves: (i) compliance with the formulary; (ii) use of lower-cost, therapeutically equivalent alternatives; (iii) reduction of harmful drug interactions; or (iv) prescription-filing efficiency through lower administrative costs.
(C) Structure. The additional or increased payments may use the same structure as medication-therapy-management fees under section 1395w–104(c)(2)(E).
(k) Services from certain providers.
(1) In general. Except under paragraph (2), a physician or other entity, other than a provider of services, that has no contract setting payment amounts with a Medicare+Choice organization described in section 1395w–21(a)(2)(A), or with an MSA-plan organization, must accept as full payment for covered services furnished to the enrollee the amount it could collect if the person were not enrolled under this part. Any penalty or other legal rule that applies to such payment for a person entitled to these subchapter benefits but not enrolled with a Medicare+Choice organization also applies to an enrolled person.
(2) Private fee-for-service plans.
(A) Balance-billing limits for contract providers.
(i) In general. For a private fee-for-service enrollee, a physician, provider of services, or other entity with a contract establishing a payment rate, including a contract deemed under subsection (j)(6), must accept as full payment for covered services no more than 115 percent of that payment rate. This total includes deductibles, coinsurance, copayments, and balance billing otherwise allowed under the plan.
(ii) Enforcement procedures. The organization offering the plan must establish procedures similar to those in section 1395w–4(g)(1)(A) to enforce that limit.
(iii) Sanction. If the organization does not establish and enforce those procedures, it is subject to intermediate sanctions under section 1395w–27(g).
(B) Noncontract providers. The minimum payment rate for noncontract providers is addressed in subsection (a)(2). Limits on an enrollee’s liability for covered services from those providers are addressed in paragraph (1) and section 1395cc(a)(1)(O).
(C) Beneficiary-liability information.
(i) In general. An organization offering a private fee-for-service plan must ensure that an enrollee who receives services for which payment is sought under the plan gets an appropriate explanation of benefits, consistent with explanations under parts A and B and, when applicable, Medicare supplemental policies. It must clearly state the enrollee’s liability, including permitted balance billing.
(ii) Advance notice. In its payment terms for inpatient hospital services* and other services the Secretary identifies as potentially involving substantial balance billing under subparagraph (A), the organization must require a hospital to give the enrollee, before providing the services and if the hospital will impose that balance billing: (I) notice that balance billing is allowed for the services; and (II) a good-faith estimate of the likely balance-billing amount, if any, based on the enrollee’s presenting condition.
(l) Return to home skilled-nursing facilities for covered post-hospital extended care.
(1) Ensuring return to the home SNF.
(A) In general. When covering post-hospital extended care services*, a Medicare+Choice plan must allow coverage through a home skilled nursing facility* if: (i) the enrollee chooses that facility; and (ii) the facility has a contract with the organization for those services, or agrees to accept substantially similar payment under the same terms that apply to similarly situated contracted skilled nursing facilities through which the enrollee would otherwise receive the services.
(B) Payment. The organization must pay the home skilled nursing facility consistently with that contract or agreement.
(2) No less favorable coverage. Coverage under paragraph (1), including the services covered, cost-sharing, and other coverage criteria, may not be less favorable than coverage for a skilled nursing facility whose post-hospital extended care services* the plan otherwise covers.
(3) Construction. This subsection does not: (A) require coverage through a skilled nursing facility that is not otherwise qualified under part A to provide benefits to Medicare beneficiaries who are not enrolled in a Medicare+Choice plan; or (B) stop a skilled nursing facility from refusing to accept an enrollee, or from setting conditions for acceptance, for post-hospital extended care services.
(4) Definitions.
(A) “Home skilled nursing facility.” For an enrollee entitled to post-hospital extended care under a Medicare+Choice plan, this quoted term means any of: (i) the skilled nursing facility where the enrollee lived when admitted to the hospital before receiving the post-hospital services; (ii) a skilled nursing facility providing the services through a continuing care retirement community that housed the enrollee at that admission; or (iii) the skilled nursing facility where the enrollee’s spouse lives when the enrollee is discharged from that hospital.
(B) “Continuing care retirement community.” For an enrollee in a Medicare+Choice plan, this quoted term means an arrangement in which an organization provides or arranges housing and health-related services under an agreement effective for the enrollee’s life or for a specified period.
(m) Additional telehealth benefits.
(1) MA-plan option. For plan year 2020 and later, subject to paragraph (3), an MA plan may provide additional telehealth benefits, as defined in paragraph (2), to people enrolled under this part.
(2) Meaning of “additional telehealth benefits.”
(A) In general. For this subsection and section 1395w–24: (i) this quoted term means services for which part B provides benefits, including services for which section 1395m(m) does not pay because its payment conditions are not met, and that have been identified for the year as clinically appropriate to provide through electronic information and telecommunications technology when the physician or practitioner providing the service is not in the same place as the enrollee; and (ii) it does not include capital or infrastructure costs and investments related to the benefits.
(B) Public comment. By November 30, 2018, the Secretary must seek comments about: (i) which items and services should count as additional telehealth benefits, including remote patient monitoring, secure messaging, store-and-forward technology, and other communication that is not face-to-face; and (ii) requirements for providing those benefits, such as training and coordination.
(3) Requirements. The Secretary must set requirements for providing additional telehealth benefits, including: (A) physician or practitioner qualifications other than licensure and other requirements such as particular training; (B) factors needed to coordinate these benefits with other items and services, including in-person services; and (C) other areas the Secretary determines.
(4) Enrollee choice. If an MA plan offers a service as an additional telehealth benefit, it must also make the service available through an in-person visit. An enrollee may choose between the in-person visit and the additional telehealth benefit.
(5) Treatment under MA. For this subsection and section 1395w–24, additional telehealth benefits provided by a plan are treated as benefits under the original Medicare fee-for-service program option.
(6) Construction. This subsection does not change subsection (a)(1)’s requirement that MA plans provide items and services, other than hospice care, for which parts A and B provide benefits, including benefits available under section 1395m(m).
(n) Information about safely disposing of certain prescription drugs.
(1) In general. If a person enrolled in an MA or MA–PD plan receives an in-home health-risk assessment on or after January 1, 2021, the plan must ensure that the assessment includes information meeting paragraph (2)’s criteria about safely disposing of controlled-substance prescription drugs. The information must include suitable drug take-back programs and information about disposal at home.
(2) Criteria. Through rulemaking, the Secretary must establish appropriate criteria for information given to a person so that it sufficiently teaches the person how to safely dispose of controlled-substance prescription drugs.
Except as provided in section 1395w–28(b)(3) of this title for MSA plans and except as provided in paragraph (6) for MA regional plans, each Medicare+Choice plan* shall provide to members enrolled under this part, through providers and other persons that meet the applicable requirements of this subchapter and part A of subchapter XI, benefits under the original medicare fee-for-service program option (and, for plan years before 2006, additional benefits required under section 1395w–24(f)(1)(A) of this title).
For purposes of this part, the term “benefits under the original medicare fee-for-service program option” means, subject to subsection (m), those items and services (other than hospice care* or coverage for organ acquisitions for kidney transplants, including as covered under section 1395rr(d) of this title) for which benefits are available under parts A and B to individuals entitled to benefits under part A and enrolled under part B, with cost-sharing* for those services as required under parts A and B or, subject to clause (iii), an actuarially equivalent level of cost-sharing as determined in this part.
In the case of an MA regional plan* in determining an actuarially equivalent level of cost-sharing with respect to benefits under the original medicare fee-for-service program option, there shall only be taken into account, with respect to the application of section 1395w–27a(b)(2) of this title, such expenses only with respect to subparagraph (A) of such section.
Subject to clause (v), cost-sharing for services described in clause (iv) shall not exceed the cost-sharing required for those services under parts A and B.
The following services are described in this clause:
Chemotherapy administration* services.
Renal dialysis services (as defined in section 1395rr(b)(14)(B) of this title).
Skilled nursing care.
Clinical diagnostic laboratory test administered during any portion of the emergency period defined in paragraph (1)(B) of section 1320b–5(g) of this title beginning on or after March 18, 2020, for the detection of SARS–CoV–2 or the diagnosis of the virus that causes COVID–19 and the administration of such test.
Specified COVID–19 testing-related services (as described in section 1395l(cc)(1) of this title) for which payment would be payable under a specified outpatient payment provision described in section 1395l(cc)(2) of this title.
A COVID–19 vaccine and its administration described in section 1395x(s)(10)(A) of this title.
A drug* or biological product that is a selected drug (as referred to in section 1320f–1(c) of this title).
Such other services that the Secretary* determines appropriate (including services that the Secretary determines require a high level of predictability and transparency for beneficiaries).
In the case of services described in clause (iv), other than subclauses (IV), (V), and (VI) of such clause, for which there is no cost-sharing required under parts A and B, cost-sharing may be required for those services in accordance with clause (i).
In the case of a product or service described in subclause (IV) or (V), respectively, of clause (iv) that is administered or furnished during any portion of the emergency period described in such subclause beginning on or after March 18, 2020, an MA plan may not impose any prior authorization or other utilization management requirements with respect to the coverage of such a product or service under such plan.
A Medicare+Choice plan (other than an MSA plan*) offered by a Medicare+Choice organization* satisfies paragraph (1)(A), with respect to benefits for items and services furnished other than through a provider or other person* that has a contract with the organization offering the plan, if the plan provides payment in an amount so that—
the sum of such payment amount and any cost sharing provided for under the plan, is equal to at least
the total dollar amount of payment for such items and services as would otherwise be authorized under parts A and B (including any balance billing permitted under such parts).
For provision relating to—
limitations on balance billing against Medicare+Choice organizations for non-contract providers, see subsection (k) and section 1395cc(a)(1)(O) of this title, and
limiting actuarial value of enrollee liability for covered benefits, see section 1395w–24(e) of this title.
In the case of a Medicare+Choice organization that offers a Medicare+Choice plan in an area in which more than one local coverage determination is applied with respect to different parts of the area, the organization may elect to have the local coverage determination for the part of the area that is most beneficial to Medicare+Choice enrollees (as identified by the Secretary) apply with respect to all Medicare+Choice enrollees enrolled in the plan.
Subject to subparagraph (D), each Medicare+Choice organization may provide to individuals enrolled under this part, other than under an MSA plan (without affording those individuals an option to decline the coverage), supplemental health care benefits that the Secretary may approve. The Secretary shall approve any such supplemental benefits unless the Secretary determines that including such supplemental benefits would substantially discourage enrollment by Medicare+Choice eligible individuals with the organization.
Subject to clause (ii), a Medicare+Choice organization may provide to individuals enrolled under this part supplemental health care benefits that the individuals may elect, at their option, to have covered.
A Medicare+Choice organization may not provide, under an MSA plan, supplemental health care benefits that cover the deductible described in section 1395w–28(b)(2)(B) of this title. In applying the previous sentence, health benefits described in section 1395ss(u)(2)(B) of this title shall not be treated as covering such deductible.
Nothing in this paragraph shall be construed as preventing a Medicare+Choice private fee-for-service plan* from offering supplemental benefits that include payment for some or all of the balance billing amounts permitted consistent with subsection (k) and coverage of additional services that the plan finds to be medically necessary. Such benefits may include reductions in cost-sharing below the actuarial value specified in section 1395w–24(e)(4)(B) of this title.
For plan year 2020 and subsequent plan years, in addition to any supplemental health care benefits otherwise provided under this paragraph, an MA plan, including a specialized MA plan for special needs individuals* (as defined in section 1395w–28(b)(6) of this title), may provide supplemental benefits described in clause (ii) to a chronically ill enrollee (as defined in clause (iii)).
Supplemental benefits described in this clause are supplemental benefits that, with respect to a chronically ill enrollee, have a reasonable expectation of improving or maintaining the health or overall function of the chronically ill enrollee and may not be limited to being primarily health related benefits.
The Secretary may, only with respect to supplemental benefits provided to a chronically ill enrollee under this subparagraph, waive the uniformity requirements under this part, as determined appropriate by the Secretary.
In this subparagraph, the term “chronically ill enrollee” means an enrollee in an MA plan that the Secretary determines—
has one or more comorbid and medically complex chronic conditions that is life threatening or significantly limits the overall health or function of the enrollee;
has a high risk of hospitalization* or other adverse health outcomes; and
requires intensive care coordination.
Notwithstanding any other provision of law, a Medicare+Choice organization may (in the case of the provision of items and services to an individual under a Medicare+Choice plan under circumstances in which payment under this subchapter is made secondary pursuant to section 1395y(b)(2) of this title) charge or authorize the provider of such services to charge, in accordance with the charges allowed under a law, plan, or policy described in such section—
the insurance carrier, employer, or other entity which under such law, plan, or policy is to pay for the provision of such services, or
such individual to the extent that the individual has been paid under such law, plan, or policy for such services.
If there is a national coverage determination or legislative change in benefits required to be provided under this part made in the period beginning on the date of an announcement under section 1395w–23(b) of this title and ending on the date of the next announcement under such section and the Secretary projects that the determination will result in a significant change in the costs to a Medicare+Choice organization of providing the benefits that are the subject of such national coverage determination and that such change in costs was not incorporated in the determination of the annual Medicare+Choice capitation rate under section 1395w–23 of this title included in the announcement made at the beginning of such period, then, unless otherwise required by law—
such determination or legislative change in benefits shall not apply to contracts under this part until the first contract year that begins after the end of such period, and
if such coverage determination or legislative change provides for coverage of additional benefits or coverage under additional circumstances, section 1395w–21(i)(1) of this title shall not apply to payment for such additional benefits or benefits provided under such additional circumstances until the first contract year that begins after the end of such period.
The projection under the previous sentence shall be based on an analysis by the Chief Actuary of the Centers for Medicare & Medicaid Services of the actuarial costs associated with the coverage determination or legislative change in benefits.
In the case of an MA plan that is an MA regional plan, benefits under the plan shall include the benefits described in paragraphs (1) and (2) of section 1395w–27a(b) of this title.
In the case of an individual who is a full-benefit dual eligible individual (as defined in section 1396u–5(c)(6) of this title) or a qualified medicare beneficiary (as defined in section 1396d(p)(1) of this title) and who is enrolled in a specialized Medicare Advantage plan for special needs individuals described in section 1395w–28(b)(6)(B)(ii) of this title, the plan may not impose cost-sharing that exceeds the amount of cost-sharing that would be permitted with respect to the individual under subchapter XIX if the individual were not enrolled in such plan.
A Medicare Advantage organization may not deny, limit, or condition the coverage or provision of benefits under this part, for individuals permitted to be enrolled with the organization under this part, based on any health status-related factor described in section 2702(a)(1) of the Public Health Service Act.1 The Secretary shall not approve a plan of an organization if the Secretary determines that the design of the plan and its benefits are likely to substantially discourage enrollment by certain MA eligible individuals with the organization.
A Medicare+Choice organization shall not discriminate with respect to participation, reimbursement, or indemnification as to any provider who is acting within the scope of the provider’s license or certification under applicable State* law, solely on the basis of such license or certification. This paragraph shall not be construed to prohibit a plan from including providers only to the extent necessary to meet the needs of the plan’s enrollees or from establishing any measure designed to maintain quality and control costs consistent with the responsibilities of the plan.
A Medicare+Choice organization shall disclose, in clear, accurate, and standardized form to each enrollee with a Medicare+Choice plan offered by the organization under this part at the time of enrollment and at least annually thereafter, the following information regarding such plan:
The plan’s service area.
Benefits offered under the plan, including information described in section 1395w–21(d)(3)(A) of this title and exclusions from coverage and, if it is an MSA plan, a comparison of benefits under such a plan with benefits under other Medicare+Choice plans.
The number, mix, and distribution of plan providers, out-of-network coverage (if any) provided by the plan, any point-of-service option (including the supplemental premium for such option), and, in the case of a specified MA plan (as defined in paragraph (3)(C)), for plan year 2028 and subsequent plan years, the information described in paragraph (3)(B).
Out-of-area coverage provided by the plan.
Coverage of emergency services, including—
the appropriate use of emergency services, including use of the 911 telephone system or its local equivalent in emergency situations and an explanation of what constitutes an emergency situation;
the process and procedures of the plan for obtaining emergency services; and
the locations of (I) emergency departments, and (II) other settings, in which plan physicians and hospitals provide emergency services and post-stabilization care.
Supplemental benefits available from the organization offering the plan, including—
whether the supplemental benefits are optional,
the supplemental benefits covered, and
the Medicare+Choice monthly supplemental beneficiary premium for the supplemental benefits.
Rules regarding prior authorization or other review requirements that could result in nonpayment.
All plan appeal or grievance rights and procedures.
A description of the organization’s quality improvement program under subsection (e).
Upon request of a Medicare+Choice eligible individual*, a Medicare+Choice organization must provide the following information to such individual:
The general coverage information and general comparative plan information made available under clauses (i) and (ii) of section 1395w–21(d)(2)(A) of this title.
Information on procedures used by the organization to control utilization of services and expenditures.
Information on the number of grievances, redeterminations, and appeals and on the disposition in the aggregate of such matters.
An overall summary description as to the method of compensation of participating physicians.
For plan year 2028 and subsequent plan years, each MA organization offering a specified MA plan (as defined in subparagraph (C)) shall, for each such plan offered by the organization—
maintain, on a publicly available internet website, an accurate provider directory that includes the information described in subparagraph (B);
not less frequently than once every 90 days (or, in the case of a hospital or any other facility determined appropriate by the Secretary, at a lesser frequency specified by the Secretary but in no case less frequently than once every 12 months), verify the provider directory information of each provider listed in such directory and, if applicable, update such information;
if the organization is unable to verify such information with respect to a provider, include in such directory an indication that the information of such provider may not be up to date; and
remove a provider from such directory within 5 business days if the organization determines that the provider is no longer a provider participating in the network of such plan.
The information described in this subparagraph is information enrollees may need to access covered benefits from a provider with which such organization offering such plan has an agreement for furnishing items and services covered under such plan, such as name, specialty, contact information, primary office or facility addresses where items or services are furnished, whether the provider is accepting new patients, accommodations for people with disabilities, cultural and linguistic capabilities, and telehealth capabilities.
In this paragraph, the term “specified MA plan” means—
a network-based plan (as defined in subsection (d)(5)(C)); or
a Medicare Advantage private fee-for-service plan (as defined in section 1395w–28(b)(2) of this title) that meets the access standards under subsection (d)(4), in whole or in part, through entering into contracts or agreements as provided for under subparagraph (B) of such subsection.
A Medicare+Choice organization offering a Medicare+Choice plan may select the providers from whom the benefits under the plan are provided so long as—
the organization makes such benefits available and accessible to each individual electing the plan within the plan service area with reasonable promptness and in a manner which assures continuity in the provision of benefits;
when medically necessary the organization makes such benefits available and accessible 24 hours a day and 7 days a week;
the plan provides for reimbursement with respect to services which are covered under subparagraphs (A) and (B) and which are provided to such an individual other than through the organization, if—
the services were not emergency services (as defined in paragraph (3)), but (I) the services were medically necessary and immediately required because of an unforeseen illness, injury, or condition, and (II) it was not reasonable given the circumstances to obtain the services through the organization,
the services were renal dialysis services and were provided other than through the organization because the individual was temporarily out of the plan’s service area,
the services are maintenance care or post-stabilization care covered under the guidelines established under paragraph (2), or
for plan year 2028 and subsequent plan years, in the case of a specified MA plan (as defined in subsection (c)(3)(C)), the services were furnished by a provider that was not participating in the network of such plan but was listed in the provider directory of such plan on the date on which the appointment was made, as described in paragraph (7)(A);
the organization provides access to appropriate providers, including credentialed specialists, for medically necessary treatment* and services; and
coverage is provided for emergency services (as defined in paragraph (3)) without regard to prior authorization or the emergency care provider’s contractual relationship with the organization.
A Medicare+Choice plan shall comply with such guidelines as the Secretary may prescribe relating to promoting efficient and timely coordination of appropriate maintenance and post-stabilization care of an enrollee after the enrollee has been determined to be stable under section 1395dd of this title.
In this subsection—
The term “emergency services” means, with respect to an individual enrolled with an organization, covered inpatient and outpatient services that—
are furnished by a provider that is qualified to furnish such services under this subchapter, and
are needed to evaluate or stabilize an emergency medical condition (as defined in subparagraph (B)).
The term “emergency medical condition” means a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that a prudent layperson, who possesses an average knowledge of health and medicine, could reasonably expect the absence of immediate medical attention to result in—
placing the health of the individual (or, with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy,
serious impairment to bodily functions, or
serious dysfunction of any bodily organ or part.
In addition to any other requirements under this part, in the case of a Medicare+Choice private fee-for-service plan, the organization offering the plan must demonstrate to the Secretary that the organization has sufficient number and range of health care professionals and providers willing to provide services under the terms of the plan. Subject to paragraphs (5) and (6), the Secretary shall find that an organization has met such requirement with respect to any category of health care professional or provider if, with respect to that category of provider—
the plan has established payment rates for covered services furnished by that category of provider that are not less than the payment rates provided for under part A, part B, or both, for such services, or
the plan has contracts or agreements (other than deemed contracts or agreements under subsection (j)(6)) with a sufficient number and range of providers within such category to meet the access standards in subparagraphs (A) through (E) of paragraph (1),
or a combination of both. The previous sentence shall not be construed as restricting the persons from whom enrollees under such a plan may obtain covered benefits, except that, if a plan entirely meets such requirement with respect to a category of health care professional or provider on the basis of subparagraph (B), it may provide for a higher beneficiary copayment in the case of health care professionals and providers of that category who do not have contracts or agreements (other than deemed contracts or agreements under subsection (j)(6)) to provide covered services under the terms of the plan.
For plan year 2011 and subsequent plan years, in the case of a Medicare Advantage private fee-for-service plan not described in paragraph (1) or (2) of section 1395w–27(i) of this title operating in a network area (as defined in subparagraph (B)), the plan shall meet the access standards under paragraph (4) in that area only through entering into written contracts as provided for under subparagraph (B) of such paragraph and not, in whole or in part, through the establishment of payment rates meeting the requirements under subparagraph (A) of such paragraph.
For purposes of subparagraph (A), the term “network area” means, for a plan year, an area which the Secretary identifies (in the Secretary’s announcement of the proposed payment rates for the previous plan year under section 1395w–23(b)(1)(B) of this title) as having at least 2 network-based plans (as defined in subparagraph (C)) with enrollment under this part as of the first day of the year in which such announcement is made.
For purposes of subparagraph (B), the term “network-based plan” means—
except as provided in clause (ii), a Medicare Advantage plan that is a coordinated care plan described in section 1395w–21(a)(2)(A)(i) of this title;
a network-based MSA plan; and
a reasonable cost reimbursement plan under section 1395mm of this title.
The term “network-based plan” shall not include an MA regional plan that, with respect to the area, meets access adequacy standards under this part substantially through the authority of section 422.112(a)(1)(ii) of title 42, Code of Federal Regulations*, rather than through written contracts.
For plan year 2011 and subsequent plan years, in the case of a Medicare Advantage private fee-for-service plan that is described in paragraph (1) or (2) of section 1395w–27(i) of this title, the plan shall meet the access standards under paragraph (4) only through entering into written contracts as provided for under subparagraph (B) of such paragraph and not, in whole or in part, through the establishment of payment rates meeting the requirements under subparagraph (A) of such paragraph.
For plan year 2028 and subsequent plan years, if an enrollee in a specified MA plan (as defined in subsection (c)(3)(C)) is furnished an item or service by a provider that is not participating in the network of such plan but is listed in the provider directory of such plan (as required to be provided to an enrollee pursuant to subsection (c)(1)(C)) on the date on which the appointment is made, and if such item or service would otherwise be covered under such plan if furnished by a provider that is participating in the network of such plan, the MA organization offering such plan shall ensure that the enrollee is only responsible for the lesser of—
the amount of cost sharing that would apply if such provider had been participating in the network of such plan; or
the amount of cost sharing that would otherwise apply (without regard to this subparagraph).
For plan year 2028 and subsequent plan years, each MA organization that offers a specified MA plan shall—
notify enrollees of their cost-sharing protections under this paragraph and make such notifications, to the extent practicable, by not later than the first day of an annual, coordinated election period under section 1395w–21(e)(3) of this title with respect to a year;
include information regarding such cost-sharing protections in the provider directory of each specified MA plan offered by the MA organization.; and
notify enrollees of their cost-sharing protections under this paragraph in the first explanation of benefits issued in a plan year.
Each MA organization shall have an ongoing quality improvement program for the purpose of improving the quality of care provided to enrollees in each MA plan offered by such organization.
As part of the quality improvement program under paragraph (1), each MA organization shall have a chronic care improvement program. Each chronic care improvement program shall have a method for monitoring and identifying enrollees with multiple or sufficiently severe chronic conditions that meet criteria established by the organization for participation under the program.
Except as provided in clauses (ii) and (iii) with respect to plans described in such clauses and subject to subparagraph (B), as part of the quality improvement program under paragraph (1), each MA organization shall provide for the collection, analysis, and reporting of data that permits the measurement of health outcomes and other indices of quality. With respect to MA private fee-for-service plans and MSA plans, the requirements under the preceding sentence may not exceed the requirements under this subparagraph with respect to MA local plans that are preferred provider organization plans, except that, for plan year 2010, the limitation under clause (iii) shall not apply and such requirements shall apply only with respect to administrative claims data.
In addition to the data required to be collected, analyzed, and reported under clause (i) and notwithstanding the limitations under subparagraph (B), as part of the quality improvement program under paragraph (1), each MA organization offering a specialized Medicare Advantage plan for special needs individuals shall provide for the collection, analysis, and reporting of data that permits the measurement of health outcomes and other indices of quality with respect to the requirements described in paragraphs (2) through (5) of subsection (f). Such data may be based on claims data and shall be at the plan level.
Clause (i) shall apply to MA organizations with respect to MA local plans that are preferred provider organization plans and to MA regional plans only insofar as services are furnished by providers or services, physicians, and other health care practitioners and suppliers that have contracts with such organization to furnish services under such plans.
In this subparagraph, the term “preferred provider organization plan” means an MA plan that—
has a network of providers that have agreed to a contractually specified reimbursement for covered benefits with the organization offering the plan;
provides for reimbursement for all covered benefits regardless of whether such benefits are provided within such network of providers; and
is offered by an organization that is not licensed or organized under State law as a health maintenance organization.
The Secretary shall not collect under subparagraph (A) data on quality, outcomes, and beneficiary satisfaction to facilitate consumer choice and program administration other than the types of data that were collected by the Secretary as of November 1, 2003.
Subject to subclause (iii), the Secretary may only change the types of data that are required to be submitted under subparagraph (A) after submitting to Congress a report on the reasons for such changes that was prepared in consultation with MA organizations and private accrediting bodies.
Nothing in the 2 subsection shall be construed as restricting the ability of the Secretary to carry out the duties under section 1395w–21(d)(4)(D) of this title.
The Secretary shall provide that a Medicare+Choice organization is deemed to meet all the requirements described in any specific clause of subparagraph (B) if the organization is accredited (and periodically reaccredited) by a private accrediting organization under a process that the Secretary has determined assures that the accrediting organization applies and enforces standards that meet or exceed the standards established under section 1395w–26 of this title to carry out the requirements in such clause.
The provisions described in this subparagraph are the following:
Paragraphs (1) through (3) of this subsection (relating to quality improvement programs).
Subsection (b) (relating to antidiscrimination).
Subsection (d) (relating to access to services).
Subsection (h) (relating to confidentiality and accuracy of enrollee records).
Subsection (i) (relating to information on advance directives).
Subsection (j) (relating to provider participation rules).
The requirements described in section 1395w–104(j) of this title, to the extent such requirements apply under section 1395w–131(c) of this title.
The Secretary shall determine, within 210 days after the date the Secretary receives an application by a private accrediting organization and using the criteria specified in section 1395bb(a)(2) of this title, whether the process of the private accrediting organization meets the requirements with respect to any specific clause in subparagraph (B) with respect to which the application is made. The Secretary may not deny such an application on the basis that it seeks to meet the requirements with respect to only one, or more than one, such specific clause.
Nothing in this paragraph shall be construed as limiting the authority of the Secretary under section 1395w–27 of this title, including the authority to terminate contracts with Medicare+Choice organizations under subsection (c)(2) of such section.
Each Medicare+Choice organization must provide meaningful procedures for hearing and resolving grievances between the organization (including any entity or individual through which the organization provides health care services) and enrollees with Medicare+Choice plans of the organization under this part.
A Medicare+Choice organization shall have a procedure for making determinations regarding whether an individual enrolled with the plan of the organization under this part is entitled to receive a health service under this section and the amount (if any) that the individual is required to pay with respect to such service. Subject to paragraph (3), such procedures shall provide for such determination to be made on a timely basis.
Such a determination that denies coverage, in whole or in part, shall be in writing and shall include a statement in understandable language of the reasons for the denial and a description of the reconsideration and appeals processes.
The organization shall provide for reconsideration of a determination described in paragraph (1)(B) upon request by the enrollee involved. The reconsideration shall be within a time period specified by the Secretary, but shall be made, subject to paragraph (3), not later than 60 days after the date of the receipt of the request for reconsideration.
A reconsideration relating to a determination to deny coverage based on a lack of medical necessity shall be made only by a physician with appropriate expertise in the field of medicine which necessitates treatment who is other than a physician involved in the initial determination.
An enrollee in a Medicare+Choice plan may request, either in writing or orally, an expedited determination under paragraph (1) or an expedited reconsideration under paragraph (2) by the Medicare+ÐChoice organization.
A physician, regardless whether the physician is affiliated with the organization or not, may request, either in writing or orally, such an expedited determination or reconsideration.
The Medicare+Choice organization shall maintain procedures for expediting organization determinations and reconsiderations when, upon request of an enrollee, the organization determines that the application of the normal time frame for making a determination (or a reconsideration involving a determination) could seriously jeopardize the life or health of the enrollee or the enrollee’s ability to regain maximum function.
In the case of a request for an expedited determination or reconsideration made under subparagraph (A)(ii), the organization shall expedite the determination or reconsideration if the request indicates that the application of the normal time frame for making a determination (or a reconsideration involving a determination) could seriously jeopardize the life or health of the enrollee or the enrollee’s ability to regain maximum function.
In cases described in clauses (i) and (ii), the organization shall notify the enrollee (and the physician involved, as appropriate) of the determination or reconsideration under time limitations established by the Secretary, but not later than 72 hours of the time of receipt of the request for the determination or reconsideration (or receipt of the information necessary to make the determination or reconsideration), or such longer period as the Secretary may permit in specified cases.
The Secretary shall contract with an independent, outside entity to review and resolve in a timely manner reconsiderations that affirm denial of coverage, in whole or in part. The provisions of section 1395ff(c)(5) of this title shall apply to independent outside entities under contract with the Secretary under this paragraph.
An enrollee with a Medicare+Choice plan of a Medicare+Choice organization under this part who is dissatisfied by reason of the enrollee’s failure to receive any health service to which the enrollee believes the enrollee is entitled and at no greater charge than the enrollee believes the enrollee is required to pay is entitled, if the amount in controversy is $100 or more, to a hearing before the Secretary to the same extent as is provided in section 405(b) of this title, and in any such hearing the Secretary shall make the organization a party. If the amount in controversy is $1,000 or more, the individual or organization shall, upon notifying the other party, be entitled to judicial review of the Secretary’s final decision as provided in section 405(g) of this title, and both the individual and the organization shall be entitled to be parties to that judicial review. In applying subsections (b) and (g) of section 405 of this title as provided in this paragraph, and in applying section 405(l) of this title thereto, any reference therein to the Commissioner of Social Security or the Social Security Administration shall be considered a reference to the Secretary or the Department of Health and Human Services, respectively. The provisions of section 1395ff(b)(1)(E)(iii) of this title shall apply with respect to dollar amounts specified in the first 2 sentences of this paragraph in the same manner as they apply to the dollar amounts specified in section 1395ff(b)(1)(E)(i) of this title.
Insofar as a Medicare+Choice organization maintains medical records or other health information regarding enrollees under this part, the Medicare+Choice organization shall establish procedures—
to safeguard the privacy of any individually identifiable enrollee information;
to maintain such records and information in a manner that is accurate and timely; and
to assure timely access of enrollees to such records and information.
Each Medicare+Choice organization shall meet the requirement of section 1395cc(f) of this title (relating to maintaining written policies and procedures respecting advance directives).
Insofar as a Medicare+Choice organization offers benefits under a Medicare+Choice plan through agreements with physicians, the organization shall establish reasonable procedures relating to the participation (under an agreement between a physician and the organization) of physicians under such a plan. Such procedures shall include—
providing notice of the rules regarding participation,
providing written notice of participation decisions that are adverse to physicians, and
providing a process within the organization for appealing such adverse decisions, including the presentation of information and views of the physician regarding such decision.
A Medicare+Choice organization shall consult with physicians who have entered into participation agreements with the organization regarding the organization’s medical policy, quality, and medical management procedures.
Subject to subparagraphs (B) and (C), a Medicare+Choice organization (in relation to an individual enrolled under a Medicare+ÐChoice plan offered by the organization under this part) shall not prohibit or otherwise restrict a covered health care professional (as defined in subparagraph (D)) from advising such an individual who is a patient of the professional about the health status of the individual or medical care* or treatment for the individual’s condition or disease, regardless of whether benefits for such care or treatment are provided under the plan, if the professional is acting within the lawful scope of practice.
Subparagraph (A) shall not be construed as requiring a Medicare+Choice plan to provide, reimburse for, or provide coverage of a counseling or referral service if the Medicare+ÐChoice organization offering the plan—
objects to the provision of such service on moral or religious grounds; and
in the manner and through the written instrumentalities such Medicare+ÐChoice organization deems appropriate, makes available information on its policies regarding such service to prospective enrollees before or during enrollment and to enrollees within 90 days after the date that the organization or plan adopts a change in policy regarding such a counseling or referral service.
Nothing in subparagraph (B) shall be construed to affect disclosure requirements under State law or under the Employee Retirement Income Security Act of 1974 [29 U.S.C. 1001 et seq.].
For purposes of this paragraph, the term “health care professional” means a physician (as defined in section 1395x(r) of this title) or other health care professional if coverage for the professional’s services is provided under the Medicare+Choice plan for the services of the professional. Such term includes a podiatrist, optometrist, chiropractor, psychologist, dentist, physician assistant, physical or occupational therapist and therapy assistant, speech-language pathologist, audiologist, registered or licensed practical nurse (including nurse practitioner*, clinical nurse specialist*, certified registered nurse anesthetist*, and certified nurse-midwife), licensed certified social worker, registered respiratory therapist, and certified respiratory therapy technician.
No Medicare+Choice organization may operate any physician incentive plan (as defined in subparagraph (B)) unless the organization provides assurances satisfactory to the Secretary that the following requirements are met:
No specific payment is made directly or indirectly under the plan to a physician or physician group as an inducement to reduce or limit medically necessary services provided with respect to a specific individual enrolled with the organization.
If the plan places a physician or physician group at substantial financial risk (as determined by the Secretary) for services not provided by the physician or physician group, the organization provides stop-loss protection for the physician or group that is adequate and appropriate, based on standards developed by the Secretary that take into account the number of physicians placed at such substantial financial risk in the group or under the plan and the number of individuals enrolled with the organization who receive services from the physician or group.
In this paragraph, the term “physician incentive plan” means any compensation arrangement between a Medicare+Choice organization and a physician or physician group that may directly or indirectly have the effect of reducing or limiting services provided with respect to individuals enrolled with the organization under this part.
A Medicare+Choice organization may not provide (directly or indirectly) for a health care professional, provider of services, or other entity providing health care services (or group of such professionals, providers, or entities) to indemnify the organization against any liability resulting from a civil action brought for any damage caused to an enrollee with a Medicare+Choice plan of the organization under this part by the organization’s denial of medically necessary care.
For purposes of applying this part (including subsection (k)(1)) and section 1395cc(a)(1)(O) of this title, a hospital (or other provider of services), a physician or other health care professional, or other entity furnishing health care services is treated as having an agreement or contract in effect with a Medicare+Choice organization (with respect to an individual enrolled in a Medicare+Choice private fee-for-service plan it offers), if—
the provider, professional, or other entity furnishes services that are covered under the plan to such an enrollee; and
before providing such services, the provider, professional, or other entity—
has been informed of the individual’s enrollment under the plan, and
either—
has been informed of the terms and conditions of payment for such services under the plan, or
is given a reasonable opportunity to obtain information concerning such terms and conditions,
in a manner reasonably designed to effect informed agreement by a provider.
The previous sentence shall only apply in the absence of an explicit agreement between such a provider, professional, or other entity and the Medicare+Choice organization.
An MA–PD plan may provide for a separate payment or otherwise provide for a differential payment for a participating physician that prescribes covered part D drugs in accordance with an electronic prescription drug program that meets standards established under section 1395w–104(e) of this title.
Such payment may take into consideration the costs of the physician in implementing such a program and may also be increased for those participating physicians who significantly increase—
formulary compliance;
lower cost, therapeutically equivalent alternatives;
reductions in adverse drug interactions; and
efficiencies in filing prescriptions through reduced administrative costs.
Additional or increased payments under this subsection may be structured in the same manner as medication therapy management fees are structured under section 1395w–104(c)(2)(E) 1 of this title.
Except as provided in paragraph (2), a physician or other entity (other than a provider of services) that does not have a contract establishing payment amounts for services furnished to an individual enrolled under this part with a Medicare+Choice organization described in section 1395w–21(a)(2)(A) of this title or with an organization offering an MSA plan shall accept as payment in full for covered services under this subchapter that are furnished to such an individual the amounts that the physician or other entity could collect if the individual were not so enrolled. Any penalty or other provision of law that applies to such a payment with respect to an individual entitled to benefits under this subchapter (but not enrolled with a Medicare+Choice organization under this part) also applies with respect to an individual so enrolled.
In the case of an individual enrolled in a Medicare+Choice private fee-for-service plan under this part, a physician, provider of services, or other entity that has a contract (including through the operation of subsection (j)(6)) establishing a payment rate for services furnished to the enrollee shall accept as payment in full for covered services under this subchapter that are furnished to such an individual an amount not to exceed (including any deductibles, coinsurance, copayments, or balance billing otherwise permitted under the plan) an amount equal to 115 percent of such payment rate.
The Medicare+Choice organization that offers such a plan shall establish procedures, similar to the procedures described in section 1395w–4(g)(1)(A) of this title, in order to carry out the previous sentence.
If the Medicare+Choice organization fails to establish and enforce procedures required under clause (ii), the organization is subject to intermediate sanctions under section 1395w–27(g) of this title.
For provision—
establishing minimum payment rate in the case of noncontract providers under a Medicare+Choice private fee-for-service plan, see subsection (a)(2); or
limiting enrollee liability in the case of covered services furnished by such providers, see paragraph (1) and section 1395cc(a)(1)(O) of this title.
Each Medicare+Choice organization that offers a Medicare+Choice private fee-for-service plan shall provide that enrollees under the plan who are furnished services for which payment is sought under the plan are provided an appropriate explanation of benefits (consistent with that provided under parts A and B and, if applicable, under medicare supplemental policies) that includes a clear statement of the amount of the enrollee’s liability (including any liability for balance billing consistent with this subsection) with respect to payments for such services.
In addition, such organization shall, in its terms and conditions of payments to hospitals for inpatient hospital services* and for other services identified by the Secretary for which the amount of the balance billing under subparagraph (A) could be substantial, require the hospital to provide to the enrollee, before furnishing such services and if the hospital imposes balance billing under subparagraph (A)—
notice of the fact that balance billing is permitted under such subparagraph for such services, and
a good faith estimate of the likely amount of such balance billing (if any), with respect to such services, based upon the presenting condition of the enrollee.
In providing coverage of post-hospital extended care services*, a Medicare+Choice plan shall provide for such coverage through a home skilled nursing facility* if the following conditions are met:
The enrollee elects to receive such coverage through such facility.
The facility has a contract with the Medicare+Choice organization for the provision of such services, or the facility agrees to accept substantially similar payment under the same terms and conditions that apply to similarly situated skilled nursing facilities that are under contract with the Medicare+Choice organization for the provision of such services and through which the enrollee would otherwise receive such services.
The organization shall provide payment to the home skilled nursing facility consistent with the contract or the agreement described in subparagraph (A)(ii), as the case may be.
The coverage provided under paragraph (1) (including scope of services, cost-sharing, and other criteria of coverage) shall be no less favorable to the enrollee than the coverage that would be provided to the enrollee with respect to a skilled nursing facility the post-hospital extended care services of which are otherwise covered under the Medicare+Choice plan.
Nothing in this subsection shall be construed to do the following:
To require coverage through a skilled nursing facility that is not otherwise qualified to provide benefits under part A for medicare beneficiaries not enrolled in a Medicare+Choice plan.
To prevent a skilled nursing facility from refusing to accept, or imposing conditions upon the acceptance of, an enrollee for the receipt of post-hospital extended care services.
In this subsection:
The term “home skilled nursing facility” means, with respect to an enrollee who is entitled to receive post-hospital extended care services under a Medicare+Choice plan, any of the following skilled nursing facilities:
The skilled nursing facility in which the enrollee resided at the time of admission to the hospital preceding the receipt of such post-hospital extended care services.
A skilled nursing facility that is providing such services through a continuing care retirement community (as defined in subparagraph (B)) which provided residence to the enrollee at the time of such admission.
The skilled nursing facility in which the spouse of the enrollee is residing at the time of discharge from such hospital.
The term “continuing care retirement community” means, with respect to an enrollee in a Medicare+Choice plan, an arrangement under which housing and health-related services are provided (or arranged) through an organization for the enrollee under an agreement that is effective for the life of the enrollee or for a specified period.
For plan year 2020 and subsequent plan years, subject to the requirements of paragraph (3), an MA plan may provide additional telehealth benefits (as defined in paragraph (2)) to individuals enrolled under this part.
For purposes of this subsection and section 1395w–24 of this title:
The term “additional telehealth benefits” means services—
for which benefits are available under part B, including services for which payment is not made under section 1395m(m) of this title due to the conditions for payment under such section; and
that are identified for such year as clinically appropriate to furnish using electronic information and telecommunications technology when a physician (as defined in section 1395x(r) of this title) or practitioner (described in section 1395u(b)(18)(C) of this title) providing the service is not at the same location as the plan enrollee.
The term “additional telehealth benefits” does not include capital and infrastructure costs and investments relating to such benefits.
Not later than November 30, 2018, the Secretary shall solicit comments on—
what types of items and services (including those provided through supplemental health care benefits, such as remote patient monitoring, secure messaging, store and forward technologies, and other non-face-to-face communication) should be considered to be additional telehealth benefits; and
the requirements for the provision or furnishing of such benefits (such as training and coordination requirements).
The Secretary shall specify requirements for the provision or furnishing of additional telehealth benefits, including with respect to the following:
Physician or practitioner qualifications (other than licensure) and other requirements such as specific training.
Factors necessary for the coordination of such benefits with other items and services including those furnished in-person.
Such other areas as determined by the Secretary.
If an MA plan provides a service as an additional telehealth benefit (as defined in paragraph (2))—
the MA plan shall also provide access to such benefit through an in-person visit (and not only as an additional telehealth benefit); and
an individual enrollee shall have discretion as to whether to receive such service through the in-person visit or as an additional telehealth benefit.
For purposes of this subsection and section 1395w–24 of this title, if a plan provides additional telehealth benefits, such additional telehealth benefits shall be treated as if they were benefits under the original Medicare fee-for-service program option.
Nothing in this subsection shall be construed as affecting the requirement under subsection (a)(1) that MA plans provide enrollees with items and services (other than hospice care) for which benefits are available under parts A and B, including benefits available under section 1395m(m) of this title.
In the case of an individual enrolled under an MA or MA–PD plan who is furnished an in-home health risk assessment on or after January 1, 2021, such plan shall ensure that such assessment includes information on the safe disposal of prescription drugs that are controlled substances that meets the criteria established under paragraph (2). Such information shall include information on drug takeback programs that meet such requirements determined appropriate by the Secretary and information on in-home disposal.
The Secretary shall, through rulemaking, establish criteria the Secretary determines appropriate with respect to information provided to an individual to ensure that such information sufficiently educates such individual on the safe disposal of prescription drugs that are controlled substances.
Source credit: (Aug. 14, 1935, ch. 531, title XVIII, § 1852, as added Pub. L. 105–33, title IV, § 4001, Aug. 5, 1997, 111 Stat. 286; amended Pub. L. 106–113, div. B, § 1000(a)(6) [title III, § 321(k)(6)(B), title V, §§ 518, 520(a)], Nov. 29, 1999, 113 Stat. 1536, 1501A–367, 1501A–384, 1501A–385; Pub. L. 106–554, § 1(a)(6) [title V, § 521(b), title VI, §§ 611(b), 615, 616, 621(a)], Dec. 21, 2000, 114 Stat. 2763, 2763A–543, 2763A–560, 2763A–561, 2763A–564; Pub. L. 108–173, title I, § 102(b), title II, §§ 211(j), 221(d)(3), 222(a)(2), (3), (h), (l)(1), 233(a)(1), (2), (c), title VII, § 722(a), (b), title IX, §§ 900(e)(1)(F), 940(b)(2)(A), 948(b)(2), Dec. 8, 2003, 117 Stat. 2153, 2180, 2193, 2195, 2196, 2204, 2206, 2209, 2347, 2348, 2371, 2417, 2426; Pub. L. 110–275, title I, §§ 125(b)(6), 162(a)(1)–(3)(A), 163(a), (b), 164(f)(1), 165(a), July 15, 2008, 122 Stat. 2519, 2569–2571, 2574, 2575; Pub. L. 111–148, title III, § 3202(a)(1), Mar. 23, 2010, 124 Stat. 454; Pub. L. 114–255, div. C, title XVII, § 17006(a)(2)(A), (c)(1), Dec. 13, 2016, 130 Stat. 1334, 1335; Pub. L. 115–123, div. E, title III, §§ 50322(a), 50323(a), Feb. 9, 2018, 132 Stat. 201, 202; Pub. L. 115–271, title VI, § 6103(a), Oct. 24, 2018, 132 Stat. 4005; Pub. L. 116–127, div. F, § 6003(a), Mar. 18, 2020, 134 Stat. 203; Pub. L. 116–136, div. A, title III, § 3713(c), Mar. 27, 2020, 134 Stat. 423; Pub. L. 117–169, title I, § 11001(b)(1)(B), Aug. 16, 2022, 136 Stat. 1851; Pub. L. 119–75, div. J, title II, § 6220(a), (b)(1), Feb. 3, 2026, 140 Stat. 656, 657.)
- 1935Enacted · Pub. L. 105-33 · 111 Stat. 286
- 1999Amended · Pub. L. 106-113 · 113 Stat. 1536, 1501
- 2000Amended · Pub. L. 106-554 · 114 Stat. 2763, 2763
- 2003Amended · Pub. L. 108-173 · 117 Stat. 2153, 2180, 2193, 2195, 2196, 2204, 2206, 2209, 2347, 2348, 2371, 2417, 2426
- 2008Amended · Pub. L. 110-275 · 122 Stat. 2519, 2569
- 2010Amended · Pub. L. 111-148 · 124 Stat. 454
- 2016Amended · Pub. L. 114-255 · 130 Stat. 1334, 1335
- 2018Amended · Pub. L. 115-123 · 132 Stat. 201, 202
- 2018Amended · Pub. L. 115-271 · 132 Stat. 4005
- 2020Amended · Pub. L. 116-127 · 134 Stat. 203
- 2020Amended · Pub. L. 116-136 · 134 Stat. 423
- 2022Amended · Pub. L. 117-169 · 136 Stat. 1851
- 2026Amended · Pub. L. 119-75 · 140 Stat. 656, 657
A history note hasn’t been published yet. The record shows enactment by Pub. L. 105-33 on 1935-08-14.
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