§1395w–22 — Title 42 The Public Health and Welfare | U.S. Code

Summary

Medicare Advantage (MA) plans must give members the same items and services covered by Original Medicare Parts A and B, except for a few special kinds of plans. Cost-sharing must match Parts A and B or be actuarially equal. For certain services — like chemotherapy, renal dialysis, skilled nursing, some COVID tests and vaccines (including services during the emergency period that began March 18, 2020), selected drugs, and other services the Secretary names — cost-sharing can never be higher than under Parts A and B, and MA plans may not require prior authorization for COVID tests or vaccines given during that emergency period. MA plans may offer extra supplemental benefits. Since plan year 2020, plans may offer extra benefits for chronically ill enrollees that can help keep or improve health and function; a “chronically ill enrollee” is someone with serious, complex chronic conditions, high risk of hospitalization, and a need for intensive care coordination. Plans must not deny or limit coverage based on a person’s health status. If a plan uses non-contracted providers, it must pay so the total paid plus any cost-sharing equals what Parts A and B would pay (including any allowed balance billing). Some private fee‑for‑service rules limit provider billing (including a 115 percent cap in certain situations). Plans must give clear information at enrollment and at least yearly about the service area, benefits, provider options, emergency care, prior authorization rules, appeals and grievances, supplemental benefits, and quality programs. For certain network-based plans, provider directories must be kept accurate and verified regularly starting plan year 2028. MA organizations must make covered care available quickly and continuously, including 24/7 access when medically needed, and must cover emergency services without regard to network status. They must run quality improvement and chronic care programs and collect quality data as required. Enrollees must have fair grievance and appeals processes: written denials must explain reasons; reconsiderations must generally be decided within 60 days; urgent (expedited) requests must be decided within 72 hours. If an enrollee seeks a hearing over a denied service and the dispute is $100 or more, the enrollee can have a hearing before the Secretary; for disputes of $1,000 or more judicial review is allowed. Plans must protect enrollee medical records, keep them accurate, and give timely access. The Secretary can accept private accreditation if it meets standards, and must decide on accreditation applications within 210 days. Plans may offer extra telehealth benefits starting plan year 2020 (the Secretary set rules and asked for comments by November 30, 2018); if a telehealth service is offered the enrollee must also be allowed an in-person visit. Post-hospital extended care can be provided through a “home skilled nursing facility” if the enrollee chooses and the facility agrees to the plan’s terms. Beginning January 1, 2021, in-home health risk assessments must include information on safe disposal of controlled prescription drugs.

Title 42, §1395w–22

The Public Health and Welfare — Source: USLM XML via OLRC

(a)(1)(A)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).

(B)(i)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.

(ii)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.

(iii)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.

(iv)The following services are described in this clause:

(I)Chemotherapy administration services.

(II)Renal dialysis services (as defined in section 1395rr(b)(14)(B) of this title).

(III)Skilled nursing care.

(IV)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.

(V)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.

(VI)A COVID–19 vaccine and its administration described in section 1395x(s)(10)(A) of this title.

(VII)A drug or biological product that is a selected drug (as referred to in section 1320f–1(c) of this title).

(VIII)Such other services that the Secretary determines appropriate (including services that the Secretary determines require a high level of predictability and transparency for beneficiaries).

(v)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).

(vi)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.

(2)(A)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—

(i)the sum of such payment amount and any cost sharing provided for under the plan, is equal to at least

(ii)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).

(B)For provision relating to—

(i)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

(ii)limiting actuarial value of enrollee liability for covered benefits, see section 1395w–24(e) of this title.

(C)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.

(3)(A)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.

(B)(i)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.

(ii)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.

(C)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.

(D)(i)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)).

(ii)(I)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.

(II)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.

(iii)In this subparagraph, the term “chronically ill enrollee” means an enrollee in an MA plan that the Secretary determines—

(I)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;

(II)has a high risk of hospitalization or other adverse health outcomes; and

(III)requires intensive care coordination.

(4)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—

(A)the insurance carrier, employer, or other entity which under such law, plan, or policy is to pay for the provision of such services, or

(B)such individual to the extent that the individual has been paid under such law, plan, or policy for such services.

(5)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—

(A)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

(B)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.

(6)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.

(7)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.

(b)(1)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.11 See References in Text note below. 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.

(2)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.

(c)(1)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:

(A)The plan’s service area.

(B)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.

(C)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).

(D)Out-of-area coverage provided by the plan.

(E)Coverage of emergency services, including—

(i)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;

(ii)the process and procedures of the plan for obtaining emergency services; and

(iii)the locations of (I) emergency departments, and (II) other settings, in which plan physicians and hospitals provide emergency services and post-stabilization care.

(F)Supplemental benefits available from the organization offering the plan, including—

(i)whether the supplemental benefits are optional,

(ii)the supplemental benefits covered, and

(iii)the Medicare+Choice monthly supplemental beneficiary premium for the supplemental benefits.

(G)Rules regarding prior authorization or other review requirements that could result in nonpayment.

(H)All plan appeal or grievance rights and procedures.

(I)A description of the organization’s quality improvement program under subsection (e).

(2)Upon request of a Medicare+Choice eligible individual, a Medicare+Choice organization must provide the following information to such individual:

(A)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.

(B)Information on procedures used by the organization to control utilization of services and expenditures.

(C)Information on the number of grievances, redeterminations, and appeals and on the disposition in the aggregate of such matters.

(D)An overall summary description as to the method of compensation of participating physicians.

(3)(A)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—

(i)maintain, on a publicly available internet website, an accurate provider directory that includes the information described in subparagraph (B);

(ii)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;

(iii)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

(iv)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.

(B)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.

(C)In this paragraph, the term “specified MA plan” 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) 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.

(d)(1)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—

(A)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;

(B)when medically necessary the organization makes such benefits available and accessible 24 hours a day and 7 days a week;

(C)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—

(i)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,

(ii)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,

(iii)the services are maintenance care or post-stabilization care covered under the guidelines established under paragraph (2), or

(iv)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);

(D)the organization provides access to appropriate providers, including credentialed specialists, for medically necessary treatment and services; and

(E)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.

(2)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.

(3)In this subsection—

(A)The term “emergency services” means, with respect to an individual enrolled with an organization, covered inpatient and outpatient services that—

(i)are furnished by a provider that is qualified to furnish such services under this subchapter, and

(ii)are needed to evaluate or stabilize an emergency medical condition (as defined in subparagraph (B)).

(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—

(i)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,

(ii)serious impairment to bodily functions, or

(iii)serious dysfunction of any bodily organ or part.

(4)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—

(A)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

(B)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),

(5)(A)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.

(B)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.

(C)(i)For purposes of subparagraph (B), the term “network-based plan” means—

(I)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;

(II)a network-based MSA plan; and

(III)a reasonable cost reimbursement plan under section 1395mm of this title.

(ii)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.

(6)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.

(7)(A)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—

(i)the amount of cost sharing that would apply if such provider had been participating in the network of such plan; or

(ii)the amount of cost sharing that would otherwise apply (without regard to this subparagraph).

(B)For plan year 2028 and subsequent plan years, each MA organization that offers a specified MA plan shall—

(i)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;

(ii)include information regarding such cost-sharing protections in the provider directory of each specified MA plan offered by the MA organization.; and

(iii)notify enrollees of their cost-sharing protections under this paragraph in the first explanation of benefits issued in a plan year.

(e)(1)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.

(2)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.

(3)(A)(i)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.

(ii)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.

(iii)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.

(iv)In this subparagraph, the term “preferred provider organization plan” means an MA plan that—

(I)has a network of providers that have agreed to a contractually specified reimbursement for covered benefits with the organization offering the plan;

(II)provides for reimbursement for all covered benefits regardless of whether such benefits are provided within such network of providers; and

(III)is offered by an organization that is not licensed or organized under State law as a health maintenance organization.

(B)(i)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.

(ii)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.

(iii)Nothing in the 22 So in original. Probably should be “this”. 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.

(4)(A)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.

(B)The provisions described in this subparagraph are the following:

(i)Paragraphs (1) through (3) of this subsection (relating to quality improvement programs).

(ii)Subsection (b) (relating to antidiscrimination).

(iii)Subsection (d) (relating to access to services).

(iv)Subsection (h) (relating to confidentiality and accuracy of enrollee records).

(v)Subsection (i) (relating to information on advance directives).

(vi)Subsection (j) (relating to provider participation rules).

(vii)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.

(C)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.

(D)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.

(f)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.

(g)(1)(A)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.

(B)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.

(2)(A)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.

(B)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.

(3)(A)(i)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.

(ii)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.

(B)(i)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.

(ii)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.

(iii)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.

(4)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.

(5)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.

(h)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—

(1)to safeguard the privacy of any individually identifiable enrollee information;

(2)to maintain such records and information in a manner that is accurate and timely; and

(3)to assure timely access of enrollees to such records and information.

(i)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).

(j)(1)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—

(A)providing notice of the rules regarding participation,

(B)providing written notice of participation decisions that are adverse to physicians, and

(C)providing a process within the organization for appealing such adverse decisions, including the presentation of information and views of the physician regarding such decision.

(2)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.

(3)(A)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.

(B)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—

(i)objects to the provision of such service on moral or religious grounds; and

(ii)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.

(C)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.].

(D)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.

(4)(A)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:

(i)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.

(ii)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.

(B)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.

(5)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.

(6)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—

(A)the provider, professional, or other entity furnishes services that are covered under the plan to such an enrollee; and

(B)before providing such services, the provider, professional, or other entity—

(i)has been informed of the individual’s enrollment under the plan, and

(ii)either—

(I)has been informed of the terms and conditions of payment for such services under the plan, or

(II)is given a reasonable opportunity to obtain information concerning such terms and conditions,

(7)(A)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.

(B)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—

(i)formulary compliance;

(ii)lower cost, therapeutically equivalent alternatives;

(iii)reductions in adverse drug interactions; and

(iv)efficiencies in filing prescriptions through reduced administrative costs.

(C)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.

(k)(1)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.

(2)(A)(i)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.

(ii)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.

(iii)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.

(B)For provision—

(i)establishing minimum payment rate in the case of noncontract providers under a Medicare+Choice private fee-for-service plan, see subsection (a)(2); or

(ii)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.

(C)(i)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.

(ii)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)—

(I)notice of the fact that balance billing is permitted under such subparagraph for such services, and

(II)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.

(l)(1)(A)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:

(i)The enrollee elects to receive such coverage through such facility.

(ii)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.

(B)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.

(2)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.

(3)Nothing in this subsection shall be construed to do the following:

(A)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.

(B)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.

(4)In this subsection:

(A)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:

(i)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.

(ii)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.

(iii)The skilled nursing facility in which the spouse of the enrollee is residing at the time of discharge from such hospital.

(B)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.

(m)(1)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.

(2)(A)For purposes of this subsection and section 1395w–24 of this title:

(i)The term “additional telehealth benefits” means services—

(I)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

(II)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.

(ii)The term “additional telehealth benefits” does not include capital and infrastructure costs and investments relating to such benefits.

(B)Not later than November 30, 2018, the Secretary shall solicit comments on—

(i)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

(ii)the requirements for the provision or furnishing of such benefits (such as training and coordination requirements).

(3)The Secretary shall specify requirements for the provision or furnishing of additional telehealth benefits, including with respect to the following:

(A)Physician or practitioner qualifications (other than licensure) and other requirements such as specific training.

(B)Factors necessary for the coordination of such benefits with other items and services including those furnished in-person.

(C)Such other areas as determined by the Secretary.

(4)If an MA plan provides a service as an additional telehealth benefit (as defined in paragraph (2))—

(A)the MA plan shall also provide access to such benefit through an in-person visit (and not only as an additional telehealth benefit); and

(B)an individual enrollee shall have discretion as to whether to receive such service through the in-person visit or as an additional telehealth benefit.

(5)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.

(6)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.

(n)(1)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.

(2)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.

Notes & Related Subsidiaries

Editorial Notes

References in Text

section 2702 of the Public Health Service Act, referred to in subsec. (b)(1), is section 2702 of act

July 1, 1944, which was classified to section 300gg–1 of this title, was amended by Pub. L. 111–148, title I, § 1201(3), Mar. 23, 2010, 124 Stat. 154, and was transferred to subsecs. (b) to (f) of section 300gg–4 of this title, effective for plan years beginning on or after Jan. 1, 2014. A new section 2702 of act

July 1, 1944, related to guaranteed availability of coverage, was added by Pub. L. 111–148, title I, § 1201(4), Mar. 23, 2010, 124 Stat. 156, effective for plan years beginning on or after Jan. 1, 2014, and is classified to section 300gg–1 of this title. The Employee Retirement Income Security Act of 1974, referred to in subsec. (j)(3)(C), is Pub. L. 93–406, Sept. 2, 1974, 88 Stat. 832, which is classified principally to chapter 18 (§ 1001 et seq.) of Title 29, Labor. For complete classification of this Act to the Code, see

Short Title

note set out under section 1001 of Title 29 and Tables. section 1395w–104(c)(2)(E) of this title, referred to in subsec. (j)(7)(C), was redesignated section 1395w–104(c)(2)(G) of this title by Pub. L. 111–148, title X, § 10328(a)(1), Mar. 23, 2010, 124 Stat. 964.

Amendments

2026—Subsec. (c)(1)(C). Pub. L. 119–75, § 6220(a)(1), substituted “plan, any” for “plan, and any” and inserted “, 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)” before period at end. Subsec. (c)(3). Pub. L. 119–75, § 6220(a)(2), added par. (3). Subsec. (d)(1)(C)(iv). Pub. L. 119–75, § 6220(b)(1)(A), added cl. (iv). Subsec. (d)(7). Pub. L. 119–75, § 6220(b)(1)(B), added par. (7). 2022—Subsec. (a)(1)(B)(iv)(VII), (VIII). Pub. L. 117–169 added subcl. (VII) and redesignated former subcl. (VII) as (VIII). 2020—Subsec. (a)(1)(B)(iv)(IV), (V). Pub. L. 116–127, § 6003(a)(1)(B), added subcls. (IV) and (V). Former subcl. (IV) redesignated (VI). Subsec. (a)(1)(B)(iv)(VI). Pub. L. 116–136, § 3713(c)(1)(B), added subcl. (VI). Former subcl. (VI) redesignated (VII). Pub. L. 116–127, § 6003(a)(1)(A), redesignated subcl. (IV) as (VI). Subsec. (a)(1)(B)(iv)(VII). Pub. L. 116–136, § 3713(c)(1)(A), redesignated subcl. (VI) as (VII). Subsec. (a)(1)(B)(v). Pub. L. 116–136, § 3713(c)(2), substituted “subclauses (IV), (V), and (VI)” for “subclauses (IV) and (V)”. Pub. L. 116–127, § 6003(a)(2), inserted “, other than subclauses (IV) and (V) of such clause,” after “clause (iv)”. Subsec. (a)(1)(B)(vi). Pub. L. 116–127, § 6003(a)(3), added cl. (vi). 2018—Subsec. (a)(1)(B)(i). Pub. L. 115–123, § 50323(a)(1), inserted “, subject to subsection (m),” after “means”. Subsec. (a)(3)(A). Pub. L. 115–123, § 50322(a)(1), substituted “Subject to subparagraph (D), each” for “Each”. Subsec. (a)(3)(D). Pub. L. 115–123, § 50322(a)(2), added subpar. (D). Subsec. (m). Pub. L. 115–123, § 50323(a)(2), added subsec. (m). Subsec. (n). Pub. L. 115–271 added subsec. (n). 2016—Subsec. (a)(1)(B)(i). Pub. L. 114–255, § 17006(c)(1), inserted “or coverage for organ acquisitions for kidney transplants, including as covered under section 1395rr(d) of this title” after “hospice care”. Subsec. (b)(1). Pub. L. 114–255, § 17006(a)(2)(A), struck out subpar. (A) designation and heading, substituted “A Medicare Advantage organization” for “A Medicare+Choice organization”, and struck out subpar. (B). Prior to amendment, text of subpar. (B) read as follows: “Subparagraph (A) shall not be construed as requiring a Medicare+Choice organization to enroll individuals who are determined to have end-stage renal disease, except as provided under section 1395w–21(a)(3)(B) of this title.” 2010—Subsec. (a)(1)(B)(i). Pub. L. 111–148, § 3202(a)(1)(A), inserted “, subject to clause (iii),” after “and B or”. Subsec. (a)(1)(B)(iii) to (v). Pub. L. 111–148, § 3202(a)(1)(B), added cls. (iii) to (v). 2008—Subsec. (a)(7). Pub. L. 110–275, § 165(a), added par. (7). Subsec. (d)(4). Pub. L. 110–275, § 162(a)(1)(A), (2)(A), in introductory provisions, substituted “Subject to paragraphs (5) and (6), the Secretary” for “The Secretary” in second sentence. Subsec. (d)(4)(B). Pub. L. 110–275, § 162(a)(3)(A), substituted “a sufficient number and range of providers within such category to meet the access standards in subparagraphs (A) through (E) of paragraph (1)” for “a sufficient number and range of providers within such category to provide covered services under the terms of the plan”. Subsec. (d)(5). Pub. L. 110–275, § 162(a)(1)(B), added par. (5). Subsec. (d)(6). Pub. L. 110–275, § 162(a)(2)(B), added par. (6). Subsec. (e)(1). Pub. L. 110–275, § 163(a), struck out “(other than an MA private fee-for-service plan or an MSA plan)” before period at end. Subsec. (e)(3)(A)(i). Pub. L. 110–275, § 163(b)(1), inserted at end “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.” Subsec. (e)(3)(A)(ii). Pub. L. 110–275, §§ 163(b)(2), 164(f)(1), added cl. (ii) and struck out former cl. (ii). Prior to amendment, text read as follows: “The Secretary shall establish as appropriate by regulation requirements for the collection, analysis, and reporting of data that permits the measurement of health outcomes and other indices of quality for MA organizations with respect to MA regional plans. Such requirements may not exceed the requirements under this subparagraph with respect to MA local plans that are preferred provider organization plans.” Subsec. (e)(3)(A)(iii). Pub. L. 110–275, § 163(b)(3), inserted “local” after “to” and “and MA regional plans” after “organizations” in heading and “and to MA regional plans” after “organization plans” in text. Subsec. (e)(4)(C). Pub. L. 110–275, § 125(b)(6), substituted “section 1395bb(a)(2)” for “section 1395bb(b)(2)”. 2003—Subsec. (a)(1). Pub. L. 108–173, § 222(a)(2), substituted “Requirement” for “In general” in par. heading, designated existing provisions as subpar. (A), inserted heading, substituted “chapter, 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 “chapter—”, added subpar. (B), and struck out former subpars. (A) and (B) which read as follows: “(A) those items and services (other than hospice care) for which benefits are available under parts A and B of this subchapter to individuals residing in the area served by the plan, and “(B) additional benefits required under section 1395w–24(f)(1)(A) of this title.” Pub. L. 108–173, § 221(d)(3)(A), inserted “and except as provided in paragraph (6) for MA regional plans” after “MSA plans” in introductory provisions. Subsec. (a)(2)(C). Pub. L. 108–173, § 948(b)(2), substituted “determination” for “policy” wherever appearing in heading and text. Subsec. (a)(3)(C). Pub. L. 108–173, § 222(a)(3), which directed insertion of “Such benefits may include reductions in cost-sharing below the actuarial value specified in section 1395w–24(e)(4)(B) of this title.” at the end of par. (3), was executed by making the insertion at the end of the final subpar. in par. (3), which was subpar. (C), to reflect the probable intent of Congress. Subsec. (a)(5). Pub. L. 108–173, § 900(e)(1)(F), substituted “Centers for Medicare & Medicaid Services” for “Health Care Financing Administration” in concluding provisions. Subsec. (a)(6). Pub. L. 108–173, § 221(d)(3)(B), added par. (6). Subsec. (b)(1)(A). Pub. L. 108–173, § 222(l)(1), inserted at end “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.” Subsec. (c)(1)(I). Pub. L. 108–173, § 722(b), amended heading and text of subpar. (I) generally. Prior to amendment, text read as follows: “A description of the organization’s quality assurance program under subsection (e) of this section, if required under such section.” Pub. L. 108–173, § 233(a)(2)(A), inserted “, if required under such section” before period at end. Subsec. (d)(4). Pub. L. 108–173, § 211(j)(2), inserted before period at end of concluding provisions “, 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”. Subsec. (d)(4)(B). Pub. L. 108–173, § 211(j)(1), inserted “(other than deemed contracts or agreements under subsection (j)(6))” after “the plan has contracts or agreements”. Subsec. (e). Pub. L. 108–173, § 722(a)(1), substituted “improvement” for “assurance” in heading. Subsec. (e)(1). Pub. L. 108–173, § 722(a)(2), reenacted heading without change and amended text generally. Prior to amendment, text read as follows: “Each Medicare+Choice organization must have arrangements, consistent with any regulation, for an ongoing quality assurance program for health care services it provides to individuals enrolled with Medicare+Choice plans (other than MSA plans) of the organization.” Pub. L. 108–173, § 233(a)(1), inserted “(other than MSA plans)” after “plans”. Subsec. (e)(2). Pub. L. 108–173, § 722(a)(2), amended par. (2) generally, substituting provisions relating to chronic care improvement programs for provisions relating to elements of the quality assurance program of an organization with respect to a Medicare+Choice plan. Subsec. (e)(2)(A). Pub. L. 108–173, § 233(a)(2)(B), struck out “, a non-network MSA plan,” after “fee-for-service plan” in introductory provisions. Subsec. (e)(2)(B). Pub. L. 108–173, § 233(a)(2)(C), struck out “, non-network MSA plans,” after “fee-for-service plans” in heading and “, a non-network MSA plan,” after “fee-for-service plan” in introductory provisions. Subsec. (e)(3). Pub. L. 108–173, § 722(a)(2), amended par. (3) generally, substituting provisions relating to collection, analysis, and reporting of data for provisions relating to external review by an independent quality review and improvement organization. Subsec. (e)(4)(B)(i). Pub. L. 108–173, § 722(a)(3)(A), amended cl. (i) generally. Prior to amendment, cl. (i) read as follows: “Paragraphs (1) and (2) of this subsection (relating to quality assurance programs).” Subsec. (e)(4)(B)(vii). Pub. L. 108–173, § 722(a)(3)(B), added cl. (vii). Subsec. (e)(5). Pub. L. 108–173, § 722(a)(4), struck out par. (5), which related to report to be submitted to Congress not later than 2 years after Dec. 21, 2000, and biennially thereafter, regarding how quality assurance programs focus on racial and ethnic minorities. Subsec. (g)(5). Pub. L. 108–173, § 940(b)(2)(A), inserted at end “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.” Subsec. (j)(4)(A). Pub. L. 108–173, § 222(h)(1), inserted “the organization provides assurances satisfactory to the Secretary that” after “unless” in introductory provisions. Subsec. (j)(4)(A)(ii). Pub. L. 108–173, § 222(h)(2), substituted “the organization” for “the organization—”, struck out subcl. (I) designation before “provides”, substituted period for “, and” at end of subcl. (I), and struck out subcl. (II), which read as follows: “conducts periodic surveys of both individuals enrolled and individuals previously enrolled with the organization to determine the degree of access of such individuals to services provided by the organization and satisfaction with the quality of such services.” Subsec. (j)(4)(A)(iii). Pub. L. 108–173, § 222(h)(3), struck out cl. (iii) which read as follows: “The organization provides the Secretary with descriptive information regarding the plan, sufficient to permit the Secretary to determine whether the plan is in compliance with the requirements of this subparagraph.” Subsec. (j)(7). Pub. L. 108–173, § 102(b), added par. (7). Subsec. (k)(1). Pub. L. 108–173, § 233(c), inserted “or with an organization offering an MSA plan” after “section 1395w–21(a)(2)(A) of this title”. 2000—Subsec. (a)(2)(C). Pub. L. 106–554, § 1(a)(6) [title VI, § 615], added subpar. (C). Subsec. (a)(5). Pub. L. 106–554, § 1(a)(6) [title VI, § 611(b)(5)], inserted concluding provisions. Pub. L. 106–554, § 1(a)(6) [title VI, § 611(b)(1), (2)], inserted “and legislative changes in benefits” after “National coverage determinations” in heading and inserted “or legislative change in benefits required to be provided under this part” after “there is a national coverage determination” in introductory provisions. Subsec. (a)(5)(A). Pub. L. 106–554, § 1(a)(6) [title VI, § 611(b)(3)], inserted “or legislative change in benefits” after “such determination”. Subsec. (a)(5)(B). Pub. L. 106–554, § 1(a)(6) [title VI, § 611(b)(4)], inserted “or legislative change” after “if such coverage determination”. Subsec. (e)(2)(A), (B). Pub. L. 106–554, § 1(a)(6) [title VI, § 616(a)], inserted concluding provisions. Subsec. (e)(5). Pub. L. 106–554, § 1(a)(6) [title VI, § 616(b)], added par. (5). Subsec. (g)(4). Pub. L. 106–554, § 1(a)(6) [title V, § 521(b)], inserted at end “The provisions of section 1395ff(c)(5) of this title shall apply to independent outside entities under contract with the Secretary under this paragraph.” Subsec. (l). Pub. L. 106–554, § 1(a)(6) [title VI, § 621(a)], added subsec. (l). 1999—Subsec. (a)(3)(A). Pub. L. 106–113, § 1000(a)(6) [title III, § 321(k)(6)(B)(i)], struck out comma after “MSA plan” and inserted comma after “the coverage)”. Subsec. (e)(2)(A). Pub. L. 106–113, § 1000(a)(6) [title V, § 520(a)(1)], substituted “, a non-network MSA plan, or a preferred provider organization plan” for “or a non-network MSA plan” in introductory provisions. Subsec. (e)(2)(B). Pub. L. 106–113, § 1000(a)(6) [title V, § 520(a)(2)], substituted “, non-network MSA plans, and preferred provider organization plans” for “and non-network MSA plans” in heading and “, a non-network MSA plan, or a preferred provider organization plan” for “or a non-network MSA plan” in introductory provisions. Subsec. (e)(2)(D). Pub. L. 106–113, § 1000(a)(6) [title V, § 520(a)(3)], added subpar. (D). Subsec. (e)(4). Pub. L. 106–113, § 1000(a)(6) [title V, § 518], amended heading and text of par. (4) generally. Prior to amendment, text read as follows: “The Secretary shall provide that a Medicare+Choice organization is deemed to meet requirements of paragraphs (1) and (2) of this subsection and subsection (h) of this section (relating to confidentiality and accuracy of enrollee records) if the organization is accredited (and periodically reaccredited) by a private organization under a process that the Secretary has determined assures that the organization, as a condition of accreditation, applies and enforces standards with respect to the requirements involved that are no less stringent than the standards established under section 1395w–26 of this title to carry out the respective requirements.” Subsec. (g)(1)(B). Pub. L. 106–113, § 1000(a)(6) [title III, § 321(k)(6)(B)(ii)(I)], inserted “or” after “in whole”. Subsec. (g)(3)(B)(ii). Pub. L. 106–113, § 1000(a)(6) [title III, § 321(k)(6)(B)(ii)(II)], inserted period at end. Subsec. (h)(2). Pub. L. 106–113, § 1000(a)(6) [title III, § 321(k)(6)(B)(iii)], substituted a semicolon for a comma before “and”. Subsec. (k)(2)(C)(ii). Pub. L. 106–113, § 1000(a)(6) [title III, § 321(k)(6)(B)(iv)], substituted “balance” for “balancing” before “billing under subparagraph (A) could” in introductory provisions.

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References to Medicare+Choice deemed to refer to Medicare Advantage or MA, subject to an appropriate transition provided by the Secretary of Health and Human Services in the use of those terms, see section 201 of Pub. L. 108–173, set out as a note under section 1395w–21 of this title.

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of 2020 AmendmentAmendment by section 3713(c) of Pub. L. 116–136 effective on Mar. 27, 2020, and applicable with respect to a COVID–19 vaccine beginning on the date that such vaccine is licensed under section 262 of this title, see section 3713(d) of Pub. L. 116–136, set out as a note under section 1395l of this title.

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of 2016 AmendmentAmendment by section 17006(a)(2)(A) of Pub. L. 114–255 applicable with respect to plan years beginning on or after Jan. 1, 2021, see section 17006(a)(3) of Pub. L. 114–255, set out as a note under section 1395w–21 of this title. Amendment by section 17006(c)(1) of Pub. L. 114–255 applicable with respect to plan years beginning on or after Jan. 1, 2021, see section 17006(c)(3) of Pub. L. 114–255, set out as a note under section 1395w–21 of this title.

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of 2010 Amendment Pub. L. 111–148, title III, § 3202(a)(2), Mar. 23, 2010, 124 Stat. 454, provided that: “The

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made by this subsection [amending this section] shall apply to plan years beginning on or after January 1, 2011.”

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of 2008 AmendmentAmendment by section 125(b)(6) of Pub. L. 110–275 applicable with respect to accreditations of hospitals granted on or after the date that is 24 months after July 15, 2008, with transition rule, see section 125(d) of Pub. L. 110–275, set out as an

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of 2008 Amendment; Transition Rule note under section 1395bb of this title. Pub. L. 110–275, title I, § 162(a)(3)(B),

July 15, 2008, 122 Stat. 2571, provided that: “The amendment made by subparagraph (A) [amending this section] shall apply to plan year 2010 and subsequent plan years.” Pub. L. 110–275, title I, § 163(c),

July 15, 2008, 122 Stat. 2571, provided that: “The

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made by this section [amending this section] shall apply to plan years beginning on or after

January 1, 2010.” Pub. L. 110–275, title I, § 164(f)(2),

July 15, 2008, 122 Stat. 2575, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect on a date specified by the Secretary of Health and Human Services (but in no case later than

January 1, 2010), and shall apply to all specialized Medicare Advantage plans for special needs individuals regardless of when the plan first entered the Medicare Advantage program under part C of title XVIII of the Social Security Act [42 U.S.C. 1395w–21 et seq.].” Pub. L. 110–275, title I, § 165(b),

July 15, 2008, 122 Stat. 2575, provided that: “The amendment made by subsection (a) [amending this section] shall apply to plan years beginning on or after

January 1, 2010.” Effective and Termination Dates of 2003 AmendmentAmendment by section 221(d)(3) and 222(a)(2), (3), (h), (l)(1) of Pub. L. 108–173 applicable with respect to plan years beginning on or after Jan. 1, 2006, see section 223(a) of Pub. L. 108–173, set out as an

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of 2003 Amendment note under section 1395w–21 of this title. Pub. L. 108–173, title II, § 233(a)(3), Dec. 8, 2003, 117 Stat. 2209, provided that: “The

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made by this subsection [amending this section] shall apply on and after the date of the enactment of this Act [Dec. 8, 2003] but shall not apply to contract years beginning on or after January 1, 2006.” Pub. L. 108–173, title VII, § 722(c), Dec. 8, 2003, 117 Stat. 2348, provided that: “The

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made by this section [amending this section] shall apply with respect to contract years beginning on and after January 1, 2006.” Amendment by section 948(b)(2) of Pub. L. 108–173 effective, except as otherwise provided, as if included in the enactment of BIPA (the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000, H.R. 5661, as enacted by section 1(a)(6) of Public Law 106–554), see section 948(e) of Pub. L. 108–173, set out as an

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of 2003 Amendment note under section 1314 of this title.

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of 2000 AmendmentAmendment by section 1(a)(6) [title V, § 521(b)] of Pub. L. 106–554 applicable with respect to initial determinations made on or after Oct. 1, 2002, see section 1(a)(6) [title V, § 521(d)] of Pub. L. 106–554, set out as a note under section 1320c–3 of this title. Pub. L. 106–554, § 1(a)(6) [title VI, § 611(c)], Dec. 21, 2000, 114 Stat. 2763, 2763A–560, provided that: “The

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made by this section [amending this section and section 1395w–23 of this title] are effective on the date of the enactment of this Act [Dec. 21, 2000] and shall apply to national coverage determinations and legislative changes in benefits occurring on or after such date.” Pub. L. 106–554, § 1(a)(6) [title VI, § 621(b)], Dec. 21, 2000, 114 Stat. 2763, 2763A–565, provided that: “The amendment made by subsection (a) [amending this section] shall apply with respect to contracts entered into or renewed on or after the date of the enactment of this Act [Dec. 21, 2000].”

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of 1999 AmendmentAmendment by section 1000(a)(6) [title III, § 321(k)(6)(B)] of Pub. L. 106–113 effective as if included in the enactment of the Balanced Budget Act of 1997, Pub. L. 105–33, except as otherwise provided, see section 1000(a)(6) [title III, § 321(m)] of Pub. L. 106–113, set out as a note under section 1395d of this title. Pub. L. 106–113, div. B, § 1000(a)(6) [title V, § 520(b)], Nov. 29, 1999, 113 Stat. 1536, 1501A–386, provided that: “The

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made by subsection (a) [amending this section] apply to contract years beginning on or after January 1, 2000.” Guidance on Maintaining Accurate Provider Directories Pub. L. 119–75, div. J, title II, § 6220(c)(1), (2), Feb. 3, 2026, 140 Stat. 660, provided that: “(1) Stakeholder meeting.—“(A) In general.—Not later than 6 months after the date of enactment of this Act [Feb. 3, 2026], the Secretary of Health and Human Services (referred to in this subsection as the ‘Secretary’) shall hold a public meeting to receive input on approaches for maintaining accurate provider directories for Medicare Advantage plans under part C of title XVIII of the Social Security Act (42 U.S.C. 1395w–21 et seq.), including input on approaches for reducing administrative burden, such as data standardization, and best practices to maintain accurate provider directory information. “(B) Participants.—Participants of the meeting under subparagraph (A) shall include representatives from the Centers for Medicare & Medicaid Services and the Assistant Secretary for Technology Policy and Office of the National Coordinator for Health Information Technology. Such meeting shall be open to the public. To the extent practicable, the Secretary shall include health care providers, companies that specialize in relevant technologies, health insurers, and patient advocates. “(2) Guidance to medicare advantage organizations.—Not later than 18 months after the date of enactment of this Act, the Secretary shall issue guidance to Medicare Advantage organizations offering Medicare Advantage plans under part C of title XVIII of the Social Security Act (42 U.S.C. 1395w–21 et seq.) on maintaining accurate provider directories for such plans, taking into consideration input received during the stakeholder meeting under paragraph (1). Such guidance may include the following, as determined appropriate by the Secretary:“(A) Best practices for Medicare Advantage organizations on how to work with providers to maintain the accuracy of provider directories and reduce provider and Medicare Advantage organization burden with respect to maintaining the accuracy of provider directories. “(B) Information on data sets and data sources with information that could be used by Medicare Advantage organizations to maintain accurate provider directories. “(C) Approaches for utilizing data sources maintained by Medicare Advantage organizations and publicly available data sets to maintain accurate provider directories. “(D) Information that may be useful to include in provider directories for Medicare beneficiaries to use in assessing plan networks when selecting a plan and accessing providers participating in plan networks during the plan year.” Implementation of 2020 Amendment Pub. L. 116–127, div. F, § 6003(b), Mar. 18, 2020, 134 Stat. 204, provided that: “Notwithstanding any other provision of law, the Secretary of Health and Human Services may implement the

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made by this section [amending this section] by program instruction or otherwise.” MedPAC Study Pub. L. 106–554, § 1(a)(6) [title VI, § 621(c)], Dec. 21, 2000, 114 Stat. 2763, 2763A–565, provided that: “(1) Study.—The Medicare Payment Advisory Commission shall conduct a study analyzing the effects of the amendment made by subsection (a) [amending this section] on Medicare+Choice organizations. In conducting such study, the Commission shall examine the effects (if any) such amendment has had—“(A) on the scope of additional benefits provided under the Medicare+Choice program; “(B) on the administrative and other costs incurred by Medicare+Choice organizations; and “(C) on the contractual relationships between such organizations and skilled nursing facilities. “(2) Report.—Not later than 2 years after the date of the enactment of this Act [Dec. 21, 2000], the Commission shall submit to Congress a report on the study conducted under paragraph (1).” Transitional Pass-Through of Additional Costs Under Medicare+Choice Program for 2000 Pub. L. 106–113, div. B, § 1000(a)(6) [title II, § 227(c)], Nov. 29, 1999, 113 Stat. 1536, 1501A–355, provided that: “The provisions of subparagraphs (A) and (B) of section 1852(a)(5) of the Social Security Act (42 U.S.C. 1395w–22(a)(5)) shall apply with respect to the coverage of additional benefits for immunosuppressive drugs under the

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made by this section [amending section 1395k and 1395x of this title] for drugs furnished in 2000 in the same manner as if such

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constituted a national coverage determination described in the matter in such section before subparagraph (A).”

§1395w–22 Benefits and beneficiary protections

Summary

Title 42, §1395w–22

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