42 C.F.R. Subpart B—Eligibility and Enrollment.
Title 42 - Public Health
(a) General rule. (1) An individual is eligible for Part D if he or she: (i) Is entitled to Medicare benefits under Part A or enrolled in Medicare Part B; and (ii) Lives in the service area of a Part D plan, as defined under §423.4. (2) Except as provided in paragraphs (b), (c), and (d) of this section, an individual is eligible to enroll in a PDP if: (i) The individual is eligible for Part D in accordance with paragraph (a)(1) of this section; (ii) The individual resides in the PDP's service area; and (iii) The individual is not enrolled in another Part D plan. (3) Retroactive Part A or Part B determinations. Individuals who become entitled to Medicare Part A or enrolled in Medicare Part B for a retroactive effective date are Part D eligible as of the month in which a notice of entitlement Part A or enrollment in Part B is provided. (b) Coordination with MA plans. A Part D eligible individual enrolled in a MA-PD plan must obtain qualified prescription drug coverage through that plan. MA enrollees are not eligible to enroll in a PDP, except as follows: (1) A Part D eligible individual is eligible to enroll in a PDP if the individual is enrolled in a MA private fee-for-service plan (as defined in section 1859(b)(2) of the Act) that does not provide qualified prescription drug coverage; and (2) A Part D eligible individual is eligible to enroll in a PDP if the individual is enrolled in a MSA plan (as defined in section 1859(b)(3) of the Act). (c) Enrollment in a PACE plan. A Part D eligible individual enrolled in a PACE plan that offers qualified prescription drug coverage under this Part must obtain such coverage through that plan. (d) Enrollment in a cost-based HMO or CMP. A Part D eligible individual enrolled in a cost-based HMO or CMP (as defined under part 417 of this chapter) that elects to receive qualified prescription drug coverage under such plan is ineligible to enroll in another Part D plan. A Part D eligible individual enrolled in a cost-based HMO or CMP offering qualified prescription drug coverage is eligible to enroll in a PDP if the individual does not elect to receive qualified prescription drug coverage under the cost-based HMO or CMP and otherwise meets the requirements of paragraph (a)(2) of this section. (a) General rule. A Part D eligible individual who wishes to enroll in a PDP may enroll during the enrollment periods specified in §423.38, by filing the appropriate enrollment form with the PDP or through other mechanisms CMS determines are appropriate. (b) Enrollment form or CMS-approved enrollment mechanism. The enrollment form or CMS-approved enrollment mechanism must comply with CMS instructions regarding content and format and must have been approved by CMS as described in §423.50. (i) The enrollment must be completed by the individual and include an acknowledgement by the beneficiary for disclosure and exchange of necessary information between the U.S. Department of Health and Human Services (or its designees) and the PDP sponsor. Individuals who assist beneficiaries in completing the enrollment, including authorized representatives, must indicate they have provided assistance and their relationship to the beneficiary. (ii) Part D eligible individuals enrolling or enrolled in a Part D plan must provide information regarding reimbursement for Part D costs through other insurance, group health plan or other third-party payment arrangement, and consent to the release of the information provided by the individual on other insurance, group health plan or other third-party payment arrangements, as well as any other information on reimbursement of Part D costs collected or obtained from other sources, in a form and manner approved by CMS. (c) Timely process an individual's enrollment request. A PDP sponsor must timely process an individual's enrollment request in accordance with CMS enrollment guidelines and enroll Part D eligible individuals who are eligible to enroll in its plan under §423.30(a) and who elect to enroll or are enrolled in the plan during the periods specified in §423.38. (d) Notice requirement. The PDP sponsor must provide the individual with prompt notice of acceptance or denial of the individual's enrollment request, in a format and manner specified by CMS. (e) Maintenance of enrollment. An individual who is enrolled in a PDP remains enrolled in that PDP until one of the following occurs: (i) The individual successfully enrolls in another PDP or MA-PD plan; (ii) The individual voluntarily disenrolls from the PDP; (iii) The individual is involuntary disenrolled from the PDP in accordance with §423.44(b)(2); (iv) The PDP is discontinued within the area in which the individual resides; or (iv) The individual is enrolled after the initial enrollment, in accordance with §423.34(c). (f) Enrollees of cost-based HMOs or CMPs and PACE. Individuals enrolled in a cost-based HMO or CMP plan (as defined in part 417 of this chapter) or PACE (as defined in §460.6 of this chapter) that offers prescription drug coverage under this part as of December 31, 2005, remain enrolled in that plan as of January 1, 2006, and receive Part D benefits offered by that plan until one of the conditions in §423.32(e) are met. (a) General rule. CMS must ensure the enrollment into Part D plans full-benefit dual eligible individuals who fail to enroll in a Part D plan. (b) Definition of full-benefit dual eligible individual. For purposes of this section, a full-benefit dual eligible individual means an individual who is: (1) Determined eligible by the State for— (i) Medical assistance for full-benefits under title XIX of the Act for the month under any eligibility category covered under the State plan or comprehensive benefits under a demonstration under section 1115 of the Act. ; or (ii) Medical assistance under section 1902(a)(10)(C) of the Act (medically needy) or section 1902(f) of the Act (States that use more restrictive eligibility criteria than are used by the SSI program) for any month if the individual was eligible for medical assistance in any part of the month. (2) Eligible for Part D in accordance with §423.30(a). (c) Enrolling a full-benefit duel eligible individual. Notwithstanding §423.32(e), during the annual coordinated election period, CMS may enroll a full-benefit dual eligible individual in another PDP if CMS determines that the further enrollment is warranted. (d) Automatic enrollment rules—(1) General rule. CMS must automatically enroll full-benefit dual eligible individuals who fail to enroll in a Part D plan into a PDP offering basic prescription drug coverage in the area where the individual resides that has a monthly beneficiary premium that does not exceed the low-income premium subsidy amount (as defined in §423.780(b)). In the event that there is more than one PDP in an area with a monthly beneficiary premium at or below the low-income premium subsidy amount, individuals must be enrolled in such PDPs on a random basis. (2) Individuals enrolled in an MSA plan or one of the following that does not offer a Part D benefit. Full-benefit dual eligible individuals enrolled in an MA Private Fee For Service (PFFS) plan or cost-based HMO or CMP that does not offer qualified prescription drug coverage or an MSA plan and who fail to enroll in a Part D plan must be automatically enrolled into a PDP plan as described in paragraph (d)(1) of this section. (e) Declining enrollment and disenrollment. Nothing in this section prevents a full-benefit dual eligible individual from— (1) Affirmatively declining enrollment in Part D; or (2) Disenrolling from the Part D plan in which the individual is enrolled and electing to enroll in another Part D plan during the special enrollment period provided under §423.38. (f) Effective date of enrollment. Enrollment of full-benefit dual eligible individuals under this section must be effective as follows: (1) January 1, 2006 for individuals who are full-benefit dual eligible individuals as of December 31, 2005; (2) The first day of the month the individual is eligible for Part D under §423.30(a)(1) for individuals who are Medicaid eligible and subsequently become newly eligible for Part D under §423.30(a)(1) on or after January 1, 2006; and (3) For individuals who are eligible for Part D under §423.30(a)(1) and subsequently become newly eligible for Medicaid on or after January 1, 2006, enrollment is effective as soon as practicable after being identified as a newly full-benefit dual eligible individual, in a process to be determined by CMS. (a) General rule. An individual may disenroll from a PDP during the periods specified in §423.38 by enrolling in a different PDP plan, submitting a disenrollment request to the PDP in the form and manner prescribed by CMS, or filing the appropriate disenrollment request through other mechanisms as determined by CMS. (b) Responsibilities of the PDP sponsor. The PDP sponsor must— (1) Submit a disenrollment notice to CMS within timeframes CMS specifies; (2) Provide the enrollee with a notice of disenrollment as CMS determines and approves; and (3) File and retain disenrollment requests for the period specified in CMS instructions. (c) Retroactive disenrollment. CMS may grant retroactive disenrollment in the following cases: (1) There never was a legally valid enrollment; or (2) A valid request for disenrollment was properly made but not processed or acted upon. (a) Initial enrollment period for Part D—Basic rule. The initial enrollment period is the period during which an individual is first eligible to enroll in a Part D plan. (1) In 2005. An individual who is first eligible to enroll in a Part D plan on or prior to January 31, 2006, has an initial enrollment period from November 15, 2005 through May 15, 2006. (2) February 2006. An individual who is first eligible to enroll in a Part D plan in February 2006 has an initial enrollment period from November 15, 2005 through May 31, 2006. (3) March 2006 and subsequent months. (i) Except as provided in paragraph (a)(3)(ii) and (a)(3)(iii) of this section, the initial enrollment period for an individual who is first eligible to enroll in a Part D plan on or after March 2006 is the same as the initial enrollment period for Medicare Part B under §407.14 of this chapter. (ii) Exception. For those individuals who are not eligible to enroll in a Part D plan at any time during their initial enrollment period for Medicare Part B, their initial enrollment period under this Part is the 3 months before becoming eligible for Part D, the month of eligibility, and the three months following eligibility to Part D. (iii) An individual who becomes entitled to Medicare Part A or enrolled in Part B for a retroactive effective date has an initial enrollment period under this Part beginning with the month in which notification of the Medicare determination is received and ending on the last day of the third month following the month in which the notification was received. (b) Annual coordinated election period—(1) For 2006. This period begins on November 15, 2005 and ends on May 15, 2006. (2) For 2007 and subsequent years. For coverage beginning 2007 or any subsequent year, the annual coordinated election period is November 15th through December 31st for coverage beginning the following calendar year. (c) Special enrollment periods. A Part D eligible individual may enroll in a PDP or disenroll from a PDP and enroll in another PDP or MA-PD plan (as provided at §422.62(b) of this chapter), as applicable, at any time under any of the following circumstances: (1) The individual involuntarily loses creditable prescription drug coverage or such coverage is involuntarily reduced so that it is no longer creditable coverage as defined under §423.56(a). Loss of credible prescription drug coverage due to failure to pay any required premium is not considered involuntary loss of the coverage. (2) The individual was not adequately informed, as required by standards established by CMS under §423.56, that he or she has lost his or her creditable prescription drug coverage, that he or she never had credible prescription drug coverage, or the coverage is involuntarily reduced so that it is no longer creditable prescription drug coverage. (3) The individual's enrollment or non-enrollment in a Part D plan is unintentional, inadvertent, or erroneous because of the error, misrepresentation, or inaction of a Federal employee, or any person authorized by the Federal government to act on its behalf. (4) The individual is a full-benefit dual eligible individual as defined under section 1935(c)(6) of the Act. (5) The individual elects to disenroll from a MA-PD plan and elects coverage under Medicare Part A and Part B in accordance with §422.62(c) of this chapter. (6) The PDP sponsor's contract is terminated by the PDP sponsor or by CMS, as provided under §423.507 through §423.510, or the PDP plan is no longer offered in the area when the individual resides. (7) The individual is no longer eligible for the PDP because of a change in his or her place of residence to a location outside of the PDP region(s) in which the PDP is offered. (8) The individual demonstrates to CMS, in accordance with guidelines issued by CMS, that— (i) The PDP sponsor offering the PDP substantially violated a material provision of its contract under this part in relation to the individual, including, but not limited to the following— (A) Failure to provide the individual on a timely basis benefits available under the plan; (B) Failure to provide benefits in accordance with applicable quality standards; or (C) The PDP (or its agent, representative, or plan provider) materially misrepresented the plan's provisions in marketing the plan to the individual. (ii) The individual meets other exceptional circumstances as CMS may provide. (a) Initial enrollment period. (1) An enrollment made prior to the month of entitlement to Part A or enrollment in Part B is effective the first day of the month the individual is entitled to or enrolled in Part A or enrolled in Part B. (2) Except as otherwise provided under §423.34(f), an enrollment made during or after the month of entitlement to Part A or enrollment in Part B is effective the first day of the calendar month following the month in which the enrollment in Part D is made. (3) If the individual is not eligible to enroll in Part D on the first day of the calendar month following the month in which the election to enroll in Part D is made, the enrollment in Part D is effective the first day of the month the individual is eligible for Part D. (4) In no case is an enrollment in Part D effective before January 1, 2006 or before entitlement to Part A or enrollment Part B. (b) Annual coordinated election periods—(1) General rule. Except as provided under paragraph (b)(2) of this section, for an enrollment or change of enrollment in Part D made during an annual coordinated election period as described in §423.38(b), the coverage or change in coverage is effective as of the first day of the following calendar year. (2) Exception for January 1, 2006 through May 15, 2006. Enrollment elections made during the annual coordinated election period between January 1, 2006 and May 15, 2006 are effective the first day of the calendar month following the month in which the enrollment in Part D is made. (c) Special enrollment periods. For an enrollment or change of enrollment in Part D made during a special enrollment period specified in §423.38(c), the effective date is determined by CMS, which, to the extent practicable, is determined in a manner consistent with protecting the continuity of health benefits coverage. (a) General rule. Except as provided in paragraphs (b) through (d) of this section, a PDP sponsor may not— (1) Involuntarily disenroll an individual from any PDP it offers; or (2) Orally or in writing, or by any action or inaction, request or encourage an individual to disenroll. (b) Basis for disenrollment—(1) Optional involuntary disenrollment. A PDP sponsor may disenroll an individual from a PDP it offers in any of the following circumstances: (i) Any monthly premium is not paid on a timely basis, as specified under paragraph (d)(1) of this section; or (ii) The individual has engaged in disruptive behavior, as specified under paragraph (d)(2) of this section. (2) Required involuntary disenrollment. A PDP sponsor must disenroll an individual from a PDP it offers in any of the following circumstances: (i) The individual no longer resides in the PDP's service area. (ii) The individual loses eligibility for Part D. (iii) Death of the individual. (iv) The PDP sponsor's contract is terminated by CMS or by a PDP or through mutual consent. The PDP sponsor must disenroll affected enrollees in accordance with the procedures for disenrollment set forth at §423.507 through §423.510. (v) The individual materially misrepresents information, as determined by CMS, to the PDP sponsor that the individual has or expects to receive reimbursement for third-party coverage. (c) Notice requirement. (1) If the disenrollment is for any of the reasons specified in paragraphs (b)(1), (b)(2)(i), or (b)(2)(iv) of this section (that is, other than death or loss of Part D eligibility, the PDP sponsor must give the individual timely notice of the disenrollment with an explanation of why the PDP is planning to disenroll the individual. (2) Notices for reasons specified in paragraphs (b)(1) through (b)(2)(i) and (b)(2)(iii) of this section must— (i) Be provided to the individual before submission of the disenrollment notice to CMS; and (ii) Include an explanation of the individual's right to file a grievance under the PDP's grievance procedures. (d) Process for disenrollment—(1) Monthly PDP premiums that are not paid timely. A PDP sponsor may disenroll an individual from the PDP for failure to pay any monthly premium under the following circumstances: (i) The PDP sponsor can demonstrate to CMS that it made reasonable efforts to collect the unpaid premium amount. (ii) The PDP sponsor gives the enrollee notice of disenrollment that meets the requirements set forth in paragraph (c) of this section. (iii) Reenrollment in the PDP. If an individual is disenrolled from the PDP for failure to pay monthly PDP premiums, the PDP sponsor has the option to decline future enrollment by the individual in any of its PDPs until the individual has paid any past premiums due to the PDP sponsor. (2) Disruptive behavior. (i) Definition. A PDP enrollee is disruptive if his or her behavior substantially impairs the plans ability to arrange or provide for services to the individual or other plan members. An individual cannot be considered disruptive if the behavior is related to the use of medical services or compliance (or noncompliance) with medical advice or treatment. (ii) Basis of disenrollment for disruptive behavior. A PDP may disenroll an individual whose behavior is disruptive as defined in §423.44(d)(2)(i) only after the PDP sponsor meets the requirements described in this section and after CMS has reviewed and approved the request. (iii) Effort to resolve the problem. The PDP sponsor must make a serious effort to resolve the problems presented by the individual, including providing reasonable accommodations, as determined by CMS, for individuals with mental or cognitive conditions, including mental illness, Alzheimers disease, and developmental disabilities. In addition, the PDP sponsor must inform the individual of the right to use the PDP's grievance procedures. The individual has a right to submit any information or explanation that he or she may wish to the PDP. (iv) Documentation. The PDP sponsor must document the enrollee's behavior, its own efforts to resolve any problems, as described in paragraph (d)(2)(iii) of this section, and any extenuating circumstances. The PDP sponsor may request from CMS the ability to decline future enrollment by the individual. The PDP sponsor must submit this information and any documentation received by the individual to CMS. (v) CMS review of the proposed disenrollment. CMS reviews the information submitted by the PDP sponsor and any information submitted by the individual (which the PDP sponsor has submitted to CMS) to determine if the PDP sponsor has fulfilled the requirements to request disenrollment for disruptive behavior. If the PDP sponsor has fulfilled the necessary requirements, CMS reviews the information and make a decision to approve or deny the request for disenrollment, including conditions on future enrollment, within 20 working days. During the review, CMS ensures that staff with appropriate clinical or medical expertise reviews the case before making a final decision. The PDP sponsor is required to provide a reasonable accommodation, as determined by CMS, for the individual in exceptional circumstances that CMS deems necessary. CMS notifies the PDP sponsor within 5 working days after making its decision. (vi) Exception for fallback prescription drug plans. CMS reserves the right to deny a request from a fallback prescription drug plan as defined in §423.855 to disenroll an individual for disruptive behavior. (vii) Effective date of disenrollment. If CMS permits a PDP to disenroll an individual for disruptive behavior, the termination is effective the first day of the calendar month after the month in which the PDP gives the individual written notice of the disenrollment that meets the requirements set forth in paragraph (c) of this section. (3) Loss of Part D eligiblity. If an individual is no longer eligible for Part D, CMS notifies the PDP that the disenrollment is effective the first day of the calendar month following the last month of Part D eligibility. (4) Death of the individual. If the individual dies, disenrollment is effective the first day of the calendar month following the month of death. (5) Individual no longer resides in the PDP service area—Basis for disenrollment. The PDP must disenroll an individual if the individual notifies the PDP that he or she has permanently moved out of the PDP service area. (6) Plan termination. (i) When a PDP contract terminates as provided in §423.507 through §423.510, the PDP sponsor must give each affected PDP enrollee notice of the effective date of the plan termination and a description of alternatives for obtaining prescription drug coverage under Part D, as specified by CMS. (ii) The notice must be sent before the effective date of the plan termination or area reduction, and in the timeframes specified by CMS. (7) Misrepresentation of third-party reimbursement. (i) If CMS determines an individual has materially misrepresented information to the PDP sponsor as described under §423.44(b)(2)(v), the termination is effective the first day of the calendar month after the month in which the PDP sponsor gives the individual written notice of the disenrollment that meets the requirements set forth in paragraph (c) of this section. (ii) Reenrollment in the PDP. Once an individual is disenrolled from the PDP for misrepresentation of third party reimbursement, the PDP sponsor has the option to decline future enrollment by the individual in any of its PDPs for a period of time CMS specifies. (a) General. A Part D eligible individual must pay the late penalty described under §423.286(d)(3) if there is a continuous period of 63 days or longer at any time after the end of the individual's initial enrollment period during which the individual meets all of the following conditions: (1) The individual was eligible to enroll in a Part D plan; (2) The individual was not covered under any creditable prescription drug coverage; and (3) The individual was not enrolled in a Part D plan. (b) [Reserved] Each Part D plan must provide, on an annual basis, and in a format and using standard terminology that CMS may specify in guidance, the information necessary to enable CMS to provide to current and potential Part D eligible individuals the information they need to make informed decisions among the available choices for Part D coverage. (a) CMS review of marketing materials. (1) Except as provided in paragraph (a)(2) and (a)(3) of this section, a Part D plan may not distribute any marketing materials (as defined in paragraph (b) of this section), or enrollment forms, or make such materials or forms available to Part D eligible individuals, unless— (i) At least 45 days (or 10 days if using certain types of marketing materials that use, without modification, proposed model language as specified by CMS) before the date of distribution, the Part D sponsor submits the material or form to CMS for review under the guidelines in paragraph (c) of this section; and (ii) CMS does not disapprove the distribution of the material or form. (2) If the Part D sponsor is deemed by CMS to meet certain performance requirements established by CMS, the Part D sponsor may distribute designated marketing materials 5 days following their submission to CMS. (3) Prior to distribution, the Part D sponsor submits and certifies that for certain types of marketing materials it followed all applicable marketing guidelines, or for certain other marketing materials that it used, without modification, proposed model language as specified by CMS. (b) Definition of marketing materials. Marketing materials include any informational materials targeted to Medicare beneficiaries which— (1) Promote the Part D plan. (2) Inform Medicare beneficiaries that they may enroll, or remain enrolled in a Part D plan. (3) Explain the benefits of enrollment in a Part D plan, or rules that apply to enrollees. (4) Explain how Medicare services are covered under a Part D plan, including conditions that apply to such coverage. (c) Examples of marketing materials. Examples of marketing materials include, but are not limited to— (1) General audience materials such as general circulation brochures, newspapers, magazines, television, radio, billboards, yellow pages, or the Internet. (2) Marketing representative materials such as scripts or outlines for telemarketing or other presentations. (3) Presentation materials such as slides and charts. (4) Promotional materials such as brochures or leaflets, including materials for circulation by third parties (for example, physicians or other providers). (5) Membership communication materials such as membership rules, subscriber agreements, member handbooks and wallet card instructions to enrollees. (6) Letters to members about contractual changes; changes in providers, premiums, benefits, plan procedures etc. (7) Membership or claims processing activities. (d) Guidelines for CMS review. In reviewing marketing material or enrollment forms under paragraph (a) of this section, CMS determines (unless otherwise specified in additional guidance) that the marketing materials— (1) Provide, in a format (and, where appropriate, print size), and using standard terminology that may be specified by CMS, the following information to Medicare beneficiaries interested in enrolling— (i) Adequate written description of rules (including any limitations on the providers from whom services can be obtained), procedures, basic benefits and services, and fees and other charges. (ii) Adequate written explanation of the grievance and appeals process, including differences between the two, and when it is appropriate to use each. (iii) Any other information necessary to enable beneficiaries to make an informed decision about enrollment. (2) Notify the general public of its enrollment period in an appropriate manner, through appropriate media, throughout its service area. (3) Include in the written materials notice that the Part D plan is authorized by law to refuse to renew its contract with CMS, that CMS also may refuse to renew the contract, and that termination or non-renewal may result in termination of the beneficiary's enrollment in the Part D plan. In addition, the Part D plan may reduce its service area and no longer be offered in the area where a beneficiary resides. (4) Are not materially inaccurate or misleading or otherwise make material misrepresentations. (5) For markets with a significant non-English speaking population, provide materials in the language of these individuals. (e) Deemed approval. If CMS has not disapproved the distribution of a marketing materials or form submitted by a Part D sponsor for a Part D plan in a Part D region, CMS is deemed to not have disapproved the distribution of the marketing material or form in all other Part D regions covered by the Part D plan, with the exception of any portion of the material or form that is specific to the Part D region. (f) Standards for Part D marketing. (1) In conducting marketing activities, a Part D plan may not— (i) Provide for cash or other remuneration as an inducement for enrollment or otherwise. This does not prohibit explanation of any legitimate benefits the beneficiary might obtain as an enrollee of the Part D plan. (ii) Engage in any discriminatory activity such as, including targeted marketing to Medicare beneficiaries from higher income areas without making comparable efforts to enroll Medicare beneficiaries from lower income areas. (iii) Solicit Medicare beneficiaries door-to-door. (iv) Engage in activities that could mislead or confuse Medicare beneficiaries, or misrepresent the Part D sponsor or its Part D plan. The Part D organization may not claim that it is recommended or endorsed by CMS or Medicare or the Department of Health and Human Services or that CMS or Medicare or the Department of Health and Human Services recommends that the beneficiary enroll in the Part D plan. The Part D organization may explain that the organization is approved for participation in Medicare. (v) Use providers, provider groups, or pharmacies to distribute printed information comparing the benefits of different Part D plans unless providers, provider groups or pharmacies accept and display materials from all Part D plan sponsors. (vi) Accept Part D plan enrollment forms in provider offices, pharmacies or other places where health care is delivered. (vii) Employ Part D plan names that suggest that a plan is not available to all Medicare beneficiaries. (viii) Engage in any other marketing activity prohibited by CMS in its marketing guidance. (2) In its marketing, the Part D organization must— (i) Demonstrate to CMS's satisfaction that marketing resources are allocated to marketing to the disabled Medicare population as well as beneficiaries age 65 and over. (ii) Establish and maintain a system for confirming that enrolled beneficiaries have in fact enrolled in the PDP and understand the rules applicable under the plan. (a) Definition. Creditable prescription drug coverage means any of the following types of coverage listed in paragraph (b) of this section only if the actuarial value of the coverage equals or exceeds the actuarial value of defined standard prescription drug coverage as demonstrated through the use of generally accepted actuarial principles and in accordance with CMS actuarial guidelines. (b) Types of coverage. The following coverage is considered creditable if it meets the definition provided in paragraph (a) of this section: (1) Prescription drug coverage under a PDP or MA-PD plan. (2) Medicaid coverage under title XIX of the Act or under a waiver under section 1115 of the Act. (3) Coverage under a group health plan, including the Federal employees health benefits program, and qualified retiree prescription drug plans as defined in section 1860D–22(a)(2) of the Act. (4) Coverage under State Pharmaceutical Assistance Programs (SPAP) as defined at §423.454. (5) Coverage of prescription drugs for veterans, survivors and dependents under chapter 17 of title 38, U.S.C. (6) Coverage under a Medicare supplemental policy (Medigap policy) as defined at §423.205. (7) Military coverage under chapter 55 of title 10, U.S.C., including TRICARE. (8) Individual health insurance coverage (as defined in section 2791(b)(5) of the Public Health Service Act) that includes coverage for outpatient prescription drugs and that does not meet the definition of an excepted benefit (as defined in section 2791(c) of the Public Health Service Act). (9) Coverage provided by the medical care program of the Indian Health Service, Tribe or Tribal organization, or Urban Indian organization (I/T/U). (10) Coverage provided by a PACE organization. (11) Coverage provided by a cost-based HMO or CMP under part 417 of this chapter. (12) Coverage provided through a State High-Risk Pool as defined under 42 CFR 146.113(a)(1)(vii). (13) Other coverage as the Secretary may determine appropriate. (c) General disclosure requirements. With the exception of PDPs and MA-PD plans under §423.56(b)(1) and PACE or cost-based HMO or CMP that provide qualified prescription drug coverage under this Part, each entity that offers prescription drug coverage under any of the types described in §423.56(b), must disclose to all Part D eligible individuals enrolled in or seeking to enroll in the coverage whether the coverage is creditable prescription drug coverage. (d) Disclosure of non-creditable coverage. In the case that the coverage of the type described in §423.56(b) is not creditable prescription drug, the disclosure described in paragraph (c) of this section to Part D eligible individuals must also include: (1) The fact that the coverage is not creditable prescription drug coverage, as provided by CMS; (2) That there are limitations on the periods in a year in which the individual may enroll in Part D plans; and (3) That the individual may be subject to a late enrollment penalty, as described under §423.46. (e) Disclosure to CMS. With the exception of PDPs and MA-PD plans under §423.56(b)(1) and PACE or cost-based HMO or CMP that provide qualified prescription drug coverage under this Part, all other entities listed under paragraph (b) of this section must disclose whether the coverage they provide is creditable prescription drug coverage to CMS in a form and manner described by CMS. (f) Notification content and timing requirements. The disclosure notification to Part-D eligible individuals required in §423.56(c) and (d) must be provided in a form and manner prescribed by CMS. Notices must be provided, at minimum, at the following times: (1) Prior to an individual's initial enrollment period for Part D, as described under §423.38(a); (2) Prior to the effective date of enrollment in the prescription drug coverage and upon any change that affects whether the coverage is creditable prescription drug coverage; (3) Prior to the commencement of the Annual Coordinated Election Period that begins on November 15 of each year, as defined in §423.38(b); and (4) Upon request by the individual. (g) When an individual is not adequately informed of coverage. If an individual establishes to CMS that he or she was not adequately informed that his or her prescription drug coverage was not creditable prescription drug coverage, the individual may apply to CMS to have the coverage treated as creditable prescription drug coverage for purposes of applying the late penalty described in §423.46.
Title 42: Public Health
PART 423—VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT
Subpart B—Eligibility and Enrollment.
§ 423.30 Eligibility and enrollment.
§ 423.32 Enrollment process.
§ 423.34 Enrollment of full-benefit dual eligible individuals.
§ 423.36 Disenrollment process.
§ 423.38 Enrollment periods.
§ 423.40 Effective dates.
§ 423.44 Involuntary disenrollment by the PDP.
§ 423.46 Late enrollment penalty.
§ 423.48 Information about Part D.
§ 423.50 Approval of marketing materials and enrollment forms.
§ 423.56 Procedures to determine and document creditable status of prescription drug coverage.
