2013 US Code
Title 42 - The Public Health and Welfare
Chapter 7 - SOCIAL SECURITY (§§ 301 - 1397mm)
Subchapter XVIII - HEALTH INSURANCE FOR AGED AND DISABLED (§§ 1395 - 1395kkk-1)
Part D - Voluntary Prescription Drug Benefit Program (§§ 1395w-101 - 1395w-154)
Subpart 1 - part d eligible individuals and prescription drug benefits (§§ 1395w-101 - 1395w-104)
Section 1395w-101 - Eligibility, enrollment, and information
Publication Title | United States Code, 2012 Edition, Supplement 1, Title 42 - THE PUBLIC HEALTH AND WELFARE |
Category | Bills and Statutes |
Collection | United States Code |
SuDoc Class Number | Y 1.2/5: |
Contained Within | Title 42 - THE PUBLIC HEALTH AND WELFARE CHAPTER 7 - SOCIAL SECURITY SUBCHAPTER XVIII - HEALTH INSURANCE FOR AGED AND DISABLED Part D - Voluntary Prescription Drug Benefit Program subpart 1 - part d eligible individuals and prescription drug benefits Sec. 1395w-101 - Eligibility, enrollment, and information |
Contains | section 1395w-101 |
Date | 2013 |
Laws in Effect as of Date | January 16, 2014 |
Positive Law | No |
Disposition | standard |
Source Credit | Aug. 14, 1935, ch. 531, title XVIII, §1860D-1, as added Pub. L. 108-173, title I, §101(a)(2), Dec. 8, 2003, 117 Stat. 2071; amended Pub. L. 109-432, div. B, title II, §206(b), Dec. 20, 2006, 120 Stat. 2990; Pub. L. 111-148, title III, §3303(b), Mar. 23, 2010, 124 Stat. 469. |
Statutes at Large References | 117 Stat. 2071, 2150, 2168, 2174 120 Stat. 2990 124 Stat. 469, 477 |
Public Law References | Public Law 108-173, Public Law 109-432, Public Law 111-148 |
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Subject to the succeeding provisions of this part, each part D eligible individual (as defined in paragraph (3)(A)) is entitled to obtain qualified prescription drug coverage (described in section 1395w–102(a) of this title) as follows:
(A) Fee-for-service enrollees may receive coverage through a prescription drug planA part D eligible individual who is not enrolled in an MA plan may obtain qualified prescription drug coverage through enrollment in a prescription drug plan (as defined in section 1395w–151(a)(14) of this title).
(B) Medicare Advantage enrollees (i) Enrollees in a plan providing qualified prescription drug coverage receive coverage through the planA part D eligible individual who is enrolled in an MA–PD plan obtains such coverage through such plan.
(ii) Limitation on enrollment of MA plan enrollees in prescription drug plansExcept as provided in clauses (iii) and (iv), a part D eligible individual who is enrolled in an MA plan may not enroll in a prescription drug plan under this part.
(iii) Private fee-for-service enrollees in MA plans not providing qualified prescription drug coverage permitted to enroll in a prescription drug planA part D eligible individual who is enrolled in an MA private fee-for-service plan (as defined in section 1395w–28(b)(2) of this title) that does not provide qualified prescription drug coverage may obtain qualified prescription drug coverage through enrollment in a prescription drug plan.
(iv) Enrollees in MSA plans permitted to enroll in a prescription drug planA part D eligible individual who is enrolled in an MSA plan (as defined in section 1395w–28(b)(3) of this title) may obtain qualified prescription drug coverage through enrollment in a prescription drug plan.
(2) Coverage first effective January 1, 2006Coverage under prescription drug plans and MA–PD plans shall first be effective on January 1, 2006.
(3) DefinitionsFor purposes of this part:
(A) Part D eligible individualThe term "part D eligible individual" means an individual who is entitled to benefits under part A of this subchapter or enrolled under part B of this subchapter.
(B) MA planThe term "MA plan" has the meaning given such term in section 1395w–28(b)(1) of this title.
(C) MA–PD planThe term "MA–PD plan" means an MA plan that provides qualified prescription drug coverage.
(b) Enrollment process for prescription drug plans (1) Establishment of process (A) In generalThe Secretary shall establish a process for the enrollment, disenrollment, termination, and change of enrollment of part D eligible individuals in prescription drug plans consistent with this subsection.
(B) Application of MA rulesIn establishing such process, the Secretary shall use rules similar to (and coordinated with) the rules for enrollment, disenrollment, termination, and change of enrollment with an MA–PD plan under the following provisions of section 1395w–21 of this title:
(i) Residence requirementsSection 1395w–21(b)(1)(A) of this title, relating to residence requirements.
(ii) Exercise of choiceSection 1395w–21(c) of this title (other than paragraph (3)(A) of such section), relating to exercise of choice.
(iii) Coverage election periodsSubject to paragraphs (2) and (3) of this subsection, section 1395w–21(e) of this title (other than subparagraphs (B), (C), and (E) of paragraph (2) and the second sentence of paragraph (4) of such section), relating to coverage election periods, including initial periods, annual coordinated election periods, special election periods, and election periods for exceptional circumstances.
(iv) Coverage periodsSection 1395w–21(f) of this title, relating to effectiveness of elections and changes of elections.
(v) Guaranteed issue and renewalSection 1395w–21(g) of this title (other than paragraph (2) of such section and clause (i) and the second sentence of clause (ii) of paragraph (3)(C) of such section), relating to guaranteed issue and renewal.
(vi) Marketing material and application formsSection 1395w–21(h) of this title, relating to approval of marketing material and application forms.
In applying clauses (ii), (iv), and (v) of this subparagraph, any reference to section 1395w–21(e) of this title shall be treated as a reference to such section as applied pursuant to clause (iii) of this subparagraph.
(C) Special ruleThe process established under subparagraph (A) shall include, except as provided in subparagraph (D), in the case of a part D eligible individual who is a full-benefit dual eligible individual (as defined in section 1396u–5(c)(6) of this title) who has failed to enroll in a prescription drug plan or an MA–PD plan, for the enrollment in a prescription drug plan that has a monthly beneficiary premium that does not exceed the premium assistance available under section 1395w–114(a)(1)(A) of this title).1 If there is more than one such plan available, the Secretary shall enroll such an individual on a random basis among all such plans in the PDP region. Nothing in the previous sentence shall prevent such an individual from declining or changing such enrollment.
(D) Special rule for plans that waive de minimis premiumsThe process established under subparagraph (A) may include, in the case of a part D eligible individual who is a subsidy eligible individual (as defined in section 1395w–114(a)(3) of this title) who has failed to enroll in a prescription drug plan or an MA–PD plan, for the enrollment in a prescription drug plan or MA–PD plan that has waived the monthly beneficiary premium for such subsidy eligible individual under section 1395w–114(a)(5) of this title. If there is more than one such plan available, the Secretary shall enroll such an individual under the preceding sentence on a random basis among all such plans in the PDP region. Nothing in the previous sentence shall prevent such an individual from declining or changing such enrollment.
(2) Initial enrollment period (A) Program initiationIn the case of an individual who is a part D eligible individual as of November 15, 2005, there shall be an initial enrollment period that shall be the same as the annual, coordinated open election period described in section 1395w–21(e)(3)(B)(iii) of this title, as applied under paragraph (1)(B)(iii).
(B) Continuing periodsIn the case of an individual who becomes a part D eligible individual after November 15, 2005, there shall be an initial enrollment period which is the period under section 1395w–21(e)(1) of this title, as applied under paragraph (1)(B)(iii) of this section, as if "entitled to benefits under part A of this subchapter or enrolled under part B of this subchapter" were substituted for "entitled to benefits under part A of this subchapter and enrolled under part B of this subchapter", but in no case shall such period end before the period described in subparagraph (A).
(3) Additional special enrollment periodsThe Secretary shall establish special enrollment periods, including the following:
(A) Involuntary loss of creditable prescription drug coverage (i) In generalIn the case of a part D eligible individual who involuntarily loses creditable prescription drug coverage (as defined in section 1395w–113(b)(4) of this title).
(ii) NoticeIn establishing special enrollment periods under clause (i), the Secretary shall take into account when the part D eligible individuals are provided notice of the loss of creditable prescription drug coverage.
(iii) Failure to pay premiumFor purposes of clause (i), a loss of coverage shall be treated as voluntary if the coverage is terminated because of failure to pay a required beneficiary premium.
(iv) Reduction in coverageFor purposes of clause (i), a reduction in coverage so that the coverage no longer meets the requirements under section 1395w–113(b)(5) of this title (relating to actuarial equivalence) shall be treated as an involuntary loss of coverage.
(B) Errors in enrollmentIn the case described in section 1395p(h) of this title (relating to errors in enrollment), in the same manner as such section applies to part B of this subchapter.
(C) Exceptional circumstancesIn the case of part D eligible individuals who meet such exceptional conditions (in addition to those conditions applied under paragraph (1)(B)(iii)) as the Secretary may provide.
(D) Medicaid coverageIn the case of an individual (as determined by the Secretary) who is a full-benefit dual eligible individual (as defined in section 1396u–5(c)(6) of this title).
(E) Discontinuance of MA–PD election during first year of eligibilityIn the case of a part D eligible individual who discontinues enrollment in an MA–PD plan under the second sentence of section 1395w–21(e)(4) of this title at the time of the election of coverage under such sentence under the original medicare fee-for-service program.
(4) Information to facilitate enrollment (A) In generalNotwithstanding any other provision of law but subject to subparagraph (B), the Secretary may provide to each PDP sponsor and MA organization such identifying information about part D eligible individuals as the Secretary determines to be necessary to facilitate efficient marketing of prescription drug plans and MA–PD plans to such individuals and enrollment of such individuals in such plans.
(B) Limitation (i) Provision of informationThe Secretary may provide the information under subparagraph (A) only to the extent necessary to carry out such subparagraph.
(ii) Use of informationSuch information provided by the Secretary to a PDP sponsor or an MA organization may be used by such sponsor or organization only to facilitate marketing of, and enrollment of part D eligible individuals in, prescription drug plans and MA–PD plans.
(5) Reference to enrollment procedures for MA–PD plansFor rules applicable to enrollment, disenrollment, termination, and change of enrollment of part D eligible individuals in MA–PD plans, see section 1395w–21 of this title.
(6) Reference to penalties for late enrollmentSection 1395w–113(b) of this title imposes a late enrollment penalty for part D eligible individuals who—
(A) enroll in a prescription drug plan or an MA–PD plan after the initial enrollment period described in paragraph (2); and
(B) fail to maintain continuous creditable prescription drug coverage during the period of non-enrollment.
(c) Providing information to beneficiaries (1) ActivitiesThe Secretary shall conduct activities that are designed to broadly disseminate information to part D eligible individuals (and prospective part D eligible individuals) regarding the coverage provided under this part. Such activities shall ensure that such information is first made available at least 30 days prior to the initial enrollment period described in subsection (b)(2)(A) of this section.
(2) RequirementsThe activities described in paragraph (1) shall—
(A) be similar to the activities performed by the Secretary under section 1395w–21(d) of this title, including dissemination (including through the toll-free telephone number 1–800–MEDICARE) of comparative information for prescription drug plans and MA–PD plans; and
(B) be coordinated with the activities performed by the Secretary under such section and under section 1395b–2 of this title.
(3) Comparative information (A) In generalSubject to subparagraph (B), the comparative information referred to in paragraph (2)(A) shall include a comparison of the following with respect to qualified prescription drug coverage:
(i) BenefitsThe benefits provided under the plan.
(ii) Monthly beneficiary premiumThe monthly beneficiary premium under the plan.
(iii) Quality and performanceThe quality and performance under the plan.
(iv) Beneficiary cost-sharingThe cost-sharing required of part D eligible individuals under the plan.
(v) Consumer satisfaction surveysThe results of consumer satisfaction surveys regarding the plan conducted pursuant to section 1395w–104(d) of this title.
(B) Exception for unavailability of informationThe Secretary is not required to provide comparative information under clauses (iii) and (v) of subparagraph (A) with respect to a plan—
(i) for the first plan year in which it is offered; and
(ii) for the next plan year if it is impracticable or the information is otherwise unavailable.
(4) Information on late enrollment penaltyThe information disseminated under paragraph (1) shall include information concerning the methodology for determining the late enrollment penalty under section 1395w–113(b) of this title.
(Aug. 14, 1935, ch. 531, title XVIII, §1860D–1, as added Pub. L. 108–173, title I, §101(a)(2), Dec. 8, 2003, 117 Stat. 2071; amended Pub. L. 109–432, div. B, title II, §206(b), Dec. 20, 2006, 120 Stat. 2990; Pub. L. 111–148, title III, §3303(b), Mar. 23, 2010, 124 Stat. 469.)
AMENDMENTS2010—Subsec. (b)(1)(C). Pub. L. 111–148, §3303(b)(1), inserted "except as provided in subparagraph (D)," after "shall include,".
Subsec. (b)(1)(D). Pub. L. 111–148, §3303(b)(2), added subpar. (D).
2006—Subsec. (b)(1)(B)(iii). Pub. L. 109–432 substituted "subparagraphs (B), (C), and (E)" for "subparagraphs (B) and (C)".
EFFECTIVE DATE OF 2010 AMENDMENTPub. L. 111–148, title III, §3303(c), Mar. 23, 2010, 124 Stat. 469, provided that: "The amendments made by this subsection [probably should be "this section", amending this section and section 1395w–114 of this title] shall apply to premiums for months, and enrollments for plan years, beginning on or after January 1, 2011."
OFFICE OF THE INSPECTOR GENERAL STUDIES AND REPORTSPub. L. 111–148, title III, §3313, Mar. 23, 2010, 124 Stat. 477, provided that:
"(a)
"(1)
"(2)
"(b)
"(1)
"(A)
"(i) A comparison, with respect to the 200 most frequently dispensed covered part D drugs under such program and covered outpatient drugs under such title (as determined by the Inspector General based on volume and expenditures), of—
"(I) the prices paid for covered part D drugs by PDP sponsors of prescription drug plans and Medicare Advantage organizations offering MA–PD plans; and
"(II) the prices paid for covered outpatient drugs by a State plan under title XIX.
"(ii) An assessment of—
"(I) the financial impact of any discrepancies in such prices on the Federal Government; and
"(II) the financial impact of any such discrepancies on enrollees under part D or individuals eligible for medical assistance under a State plan under title XIX.
"(B)
"(C)
"(2)
"(A)
"(B)
"(3)
"(A)
"(B)
"(C) MA–PD
"(D)
"(E) PDP
"(F)
Pub. L. 108–173, title I, §101(b), Dec. 8, 2003, 117 Stat. 2150, provided that: "Not later than 6 months after the date of the enactment of this Act [Dec. 8, 2003], the Secretary [of Health and Human Services] shall submit to the appropriate committees of Congress a legislative proposal providing for such technical and conforming amendments in the law as are required by the provisions of this title and title II [see Tables for classification]."
STUDY ON TRANSITIONING PART B PRESCRIPTION DRUG COVERAGEPub. L. 108–173, title I, §101(c), Dec. 8, 2003, 117 Stat. 2150, provided that: "Not later than January 1, 2005, the Secretary [of Health and Human Services] shall submit a report to Congress that makes recommendations regarding methods for providing benefits under subpart 1 of part D of title XVIII of the Social Security Act [42 U.S.C. 1395w–101 et seq.] for outpatient prescription drugs for which benefits are provided under part B of such title [42 U.S.C. 1395j et seq.]."
REPORT ON PROGRESS IN IMPLEMENTATION OF PRESCRIPTION DRUG BENEFITPub. L. 108–173, title I, §101(d), Dec. 8, 2003, 117 Stat. 2150, provided that: "Not later than March 1, 2005, the Secretary [of Health and Human Services] shall submit a report to Congress on the progress that has been made in implementing the prescription drug benefit under this title [see Tables for classification]. The Secretary shall include in the report specific steps that have been taken, and that need to be taken, to ensure a timely start of the program on January 1, 2006. The report shall include recommendations regarding an appropriate transition from the program under section 1860D–31 of the Social Security Act [42 U.S.C. 1395w–141] to prescription drug benefits under subpart 1 of part D of title XVIII of such Act [42 U.S.C. 1395w–101 et seq.]."
STATE PHARMACEUTICAL ASSISTANCE TRANSITION COMMISSIONPub. L. 108–173, title I, §106, Dec. 8, 2003, 117 Stat. 2168, provided that:
"(a)
"(1)
"(2)
"(A)
"(B)
"(b)
"(1) A representative of each Governor of each State that the Secretary [of Health and Human Services] identifies as operating on a statewide basis a State pharmaceutical assistance program that provides for eligibility and benefits that are comparable or more generous than the low-income assistance eligibility and benefits offered under section 1860D–14 of the Social Security Act [42 U.S.C. 1395w–114].
"(2) Representatives from other States that the Secretary identifies have in operation other State pharmaceutical assistance programs, as appointed by the Secretary.
"(3) Representatives of organizations that have an inherent interest in program participants or the program itself, as appointed by the Secretary but not to exceed the number of representatives under paragraphs (1) and (2).
"(4) Representatives of Medicare Advantage organizations, pharmaceutical benefit managers, and other private health insurance plans, as appointed by the Secretary.
"(5) The Secretary (or the Secretary's designee) and such other members as the Secretary may specify.
The Secretary shall designate a member to serve as Chair of the Commission and the Commission shall meet at the call of the Chair.
"(c)
"(1) Protection of the interests of program participants in a manner that is the least disruptive to such participants and that includes a single point of contact for enrollment and processing of benefits.
"(2) Protection of the financial and flexibility interests of States so that States are not financially worse off as a result of the enactment of this title [see Tables for classification].
"(3) Principles of medicare modernization under this Act [see Tables for classification].
"(d)
"(e)
"(f)
Pub. L. 108–173, title I, §110, Dec. 8, 2003, 117 Stat. 2174, provided that:
"(a)
"(1) An assessment of the differences in costs incurred by such enrollees and plans for prescription drugs dispensed by mail-order pharmacies owned by pharmaceutical benefit managers compared to mail-order pharmacies not owned by pharmaceutical benefit managers, and community pharmacies.
"(2) Whether such plans are acting in a manner that maximizes competition and results in lower prescription drug prices for enrollees.
"(b)
"(c)
1 So in original. The closing parenthesis probably should not appear.
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