42 U.S.C. § 1395w–141 — Medicare prescription drug discount card and transitional assistance program
submitted 91 years ago by Pub. L. 108-173 to r/title-42-THE-PUBLIC-HEALTH-AND-WELFARE · 7,171 words · no verdicts yet
This section creates a Medicare prescription-drug discount-card program and transitional assistance for certain people with low incomes. It sets rules for eligibility, enrollment, negotiated prices, assistance amounts, sponsors, oversight, territories, and funding.
(a) Establishment of program
(1) In general. The Secretary* must establish a program under this section: (A) to endorse prescription-drug* discount-card programs that meet this section’s requirements, so prescription-drug-card sponsors can provide discounts throughout the United States* to people eligible for a discount card; and (B) to provide transitional assistance to eligible people enrolled in those endorsed programs.
(2) Period of operation. (A) Implementation deadline. The Secretary must implement the program so discount cards and transitional assistance are first available no later than 6 months after December 8, 2003. (B) Expediting implementation. The Secretary must issue regulations* carrying out the program. An interim final regulation may take effect immediately when published. If the Secretary uses one, the Secretary must allow public comments after publication and may change or revise the regulation after the comment period ends. (C) Termination and transition. (i) In general. Subject to clause (ii), (I) the program does not apply to covered discount-card drugs dispensed after December 31, 2005; and (II) after that date, transitional assistance remains available only to the extent it concerns drugs dispensed on or before that date. (ii) Transition. For a person* enrolled in an endorsed program on December 31, 2005, and during any transition period under clause (iii), under transition rules set by the Secretary: (I) the program may continue to apply to covered discount-card drugs dispensed to that person during the transition period; (II) no annual enrollment fee applies during that period; (III) the person may not change the endorsed program plan during that period; and (IV) any transitional-assistance balance left on January 1, 2006, remains available for drugs dispensed during the person’s transition period. (iii) Transition period. The period begins January 1, 2006. It ends, for a person who enrolls in a prescription-drug plan or MA–PD plan* before the last day of the initial enrollment period under section 1395w–101(b)(2)(A), on the effective date of that person’s coverage under that part. For a person who does not enroll before that deadline, it ends on the last day of the initial enrollment period.
(3) Voluntary nature of program. This section does not require a person eligible for a discount card to enroll in an endorsed program.
(4) Glossary and definitions. For this section: (A) “Covered discount card drug” means what “covered part D drug*” means under section 1395w–102(e); this section does not define that term. (B) “Discount card eligible individual” is defined in subsection (b)(1)(A). (C) “Endorsed discount card program” and “endorsed program” mean a prescription-drug discount-card program endorsed under this section for which the sponsor has a contract with the Secretary. (D) “Negotiated prices” are described in subsection (e)(1)(A)(ii). (E) “Prescription drug card sponsor” and “sponsor” are defined in subsection (h)(1)(A). (F) “State” has the meaning given to it for subchapter XIX; this section does not define that term. (G) “Transitional assistance eligible individual” is defined in subsection (b)(2).
(b) Eligibility for discount card and transitional assistance. For this section:
(1) Discount-card-eligible individual. (A) In general. A “discount card eligible individual” is a person who (i) is entitled to benefits under part A, enrolled under part A, or enrolled under part B; and (ii), subject to paragraph (4), is not a person described in subparagraph (B). (B) Individual described. This means a person described in subparagraph (A)(i) who is enrolled under subchapter XIX, or under a section 1315 waiver of that subchapter’s requirements, and is entitled to medical assistance for outpatient prescription drugs described in section 1396d(a)(12).
(2) Transitional-assistance-eligible individual. (A) In general. Subject to subparagraph (B), this means a discount-card-eligible person who lives in one of the 50 States or the District of Columbia and whose income, determined under subsection (f)(1)(B), is no more than 135 percent of the poverty line* for the person’s family size. The poverty line is defined in section 9902(2), including revisions required there; this section does not define it. Family size is determined under subsection (f)(1)(B). (B) Exclusion for certain drug coverage. This term does not include a person who has coverage of, or assistance for, covered discount-card drugs under: (i) a group health plan* or health-insurance coverage as defined in section 300gg–91, except coverage under a part C plan and coverage consisting only of excepted benefits; (ii) chapter 55 of title 10, concerning medical and dental care for uniformed-service members; or (iii) a plan under chapter 89 of title 5, concerning the Federal employees’ health-benefits program.
(3) Special transitional-assistance-eligible individual. This means a transitional-assistance-eligible person whose income, determined under subsection (f)(1)(B), is no more than 100 percent of the poverty line for the person’s family size.
(4) Medicaid medically needy. The Secretary must provide appropriate rules treating medically needy people described in section 1396a(a)(10)(C) as discount-card-eligible and transitional-assistance-eligible people.
(c) Enrollment and enrollment fees
(1) Enrollment process. The Secretary must establish a process for enrolling and disenrolling discount-card-eligible people in endorsed programs, consistent with these rules: (A) Continuous open enrollment. Subject to the rest of this paragraph and subsection (h)(9), a discount-card-eligible person who is not enrolled and lives in a State may enroll in any endorsed program that serves State residents, at any time from the initial enrollment date set by the Secretary until before January 1, 2006. (B) Standard enrollment form. Enrollment may occur only through a standard form specified by the Secretary. Each sponsor must send the Secretary, in the required form and manner, information about people who complete the forms and, as provided under subsection (f), information about certification as transitional-assistance-eligible. (C) One program only. (i) Subject to clauses (ii) and (iii), a person may be enrolled in only one endorsed program. (ii) For 2005, the Secretary must create a process similar to, and coordinated with, the 2004 annual coordinated-election process under section 1395w–21(e)(3), so an enrolled person may change programs for 2005. (iii) The Secretary must allow a change when a person moves outside the program’s service area and in other exceptional cases the Secretary provides, considering the special-election circumstances under section 1395w–21(e)(4). The Secretary may treat a change in living setting, such as placement in a nursing facility, or enrollment in or disenrollment from a part C plan through which the person was enrolled in the endorsed program, as an exceptional circumstance. (D) Disenrollment. (i) Voluntary. A person may leave an endorsed program at any time. After doing so, the person may not enroll in another endorsed program except in an exceptional circumstance recognized under subparagraph (C)(iii) or during the annual coordinated enrollment period under subparagraph (C)(ii). (ii) Involuntary. A sponsor may disenroll an enrolled person who is not transitional-assistance-eligible if the person fails to pay a required annual enrollment fee. (E) Certain enrollees. If a discount-card-eligible person is enrolled in a plan described in section 1395w–21(a)(2)(A), or under a reasonable-cost reimbursement contract under section 1395mm(h), offered by an organization that is also a sponsor offering an endorsed program in which the person may enroll and that elected the special rules under subsection (h)(9)(B), the person may enroll only in that sponsor’s endorsed program.
(2) Enrollment fees. (A) A sponsor may charge an annual fee for each enrolled discount-card-eligible person. The fee for 2004 or 2005 is not prorated for part of a year. No fee may be charged for a year after 2005. (B) The fee may not exceed $30. (C) A sponsor must charge the same fee, if any, to all discount-card-eligible people in the program who live in the State. (D) The sponsor collects the fee. (E) Under subsection (g)(1)(A), the Secretary pays the fee for a transitional-assistance-eligible person. (F) Optional State payment. (i) The Secretary must arrange for a State to pay some or all of the fee for some or all enrolled people who are not transitional-assistance-eligible, as the State specifies. The State pays the sponsor directly. (ii) State payments under clause (i) are not State expenditures for Federal matching payments under subchapter XIX or XXI. (G) The Secretary must make special rules for an annual fee when a person changes programs during a year.
(3) Discount card. Each sponsor must issue each enrolled discount-card-eligible person a card in the Secretary’s standard format. The card proves enrollment and can identify the sponsor, program, and person in a coordinated way.
(4) Access period. Access to negotiated prices and any transitional assistance begins on the date the Secretary specifies.
(d) Information about enrollment and program features
(1) Secretary’s responsibilities. (A) The Secretary must broadly distribute information to eligible and potentially eligible people about enrollment and the program’s features, including transitional assistance. (B) To promote informed choice, the Secretary must distribute information comparing fees and other program features, which may include comparative covered-drug prices, and educational material explaining that discounts on covered drugs can vary. When practical, the comparison must be coordinated with information about other Medicare options. (C) When practical, this information must reach eligible people at least 30 days before the initial enrollment date. (D) Through 1–800–MEDICARE, the Secretary must receive and answer questions and complaints about this program and endorsed programs. (2) Sponsor responsibilities. (A) Each sponsor must make available, through the Internet and otherwise, information the Secretary identifies as needed for informed choice, including fees and negotiated prices charged for covered drugs. (B) Each sponsor must have a method, including a toll-free number, to give enrolled people requested details such as negotiated prices and remaining transitional assistance. It must tell transitional-assistance-eligible enrollees that the number provides remaining-assistance information. (C) At the point of sale, each sponsor must make information about remaining assistance available electronically or by telephone. (3) Public disclosure of equivalent-drug prices. (A) A sponsor must require each dispensing pharmacy to tell an enrolled eligible person the difference between the enrollee’s drug price and the price under the program of the lowest-priced generic covered drug that is therapeutically and bioequivalent and available at that pharmacy. (B) (i) The pharmacy must give this information when the drug is bought, or, for mail order, when delivered. (ii) The Secretary may waive that timing rule in specified circumstances.
(e) Discount-card features
(1) Savings through negotiated prices. (A) (i) Each sponsor must give enrolled eligible people access to negotiated prices. (ii) Negotiated prices must account for negotiated concessions for covered drugs, including discounts, direct or indirect subsidies, rebates, and direct or indirect remuneration, and must include dispensing fees. (B) Each sponsor must include enough pharmacies in its network that dispense drugs directly to enrollees, not only by mail, to provide convenient access at negotiated prices under the Secretary’s rules. Those rules may not be less favorable than the March 13, 2003, convenient-access standards in the Department of Defense TRICARE Retail Pharmacy solicitation statement of work numbered MDA906–03–R–0002. (C) (i) Subject to clause (ii), a sponsor and a pharmacy contracting with it may not charge an enrollee for items or services the sponsor must provide under this section. (ii) This does not prevent the sponsor from charging the annual fee, except to a transitional-assistance-eligible person, or the pharmacy from charging, consistently with the negotiated price, for the dispensed covered drug after reducing the charge by available transitional assistance. (D) Prices negotiated with manufacturers under an endorsed program do not count in establishing Medicaid’s best price under section 1396r–8(c)(1)(C), despite other law.
(2) Medication safety. Each endorsed program must use a system to reduce likely medication errors and harmful drug interactions and to improve use of medication.
(f) Eligibility procedures
(1) Determinations. (A) The Secretary must specify procedures, consistent with this subsection, for deciding whether a person is discount-card-eligible, transitional-assistance-eligible, or special-transitional-assistance-eligible. (B) Income and family size. The Secretary must define “income” and “family size” and specify how and for what period they are measured. If prior income or family size is used, the Secretary must let a person whose income or family size changed choose to have eligibility based on a more recent period, through reconsideration or another process.
(2) Self-certification. (A) A person seeking either type of transitional assistance, or another qualified person acting for that person, must use the enrollment form or another specified form and a simplified method to certify the person’s income, family size, and prescription-drug coverage, as relevant to eligibility. The certification is made under penalty of perjury or a similar penalty for false statements. It counts as consent to verification under paragraph (3), and may be made before, during, or after enrollment. (B) If verified, the Secretary must treat the certification as a determination of the applicable eligibility for the entire time the person is enrolled in any endorsed program.
(3) Verification. (A) The Secretary must establish ways, possibly using sampling and the information in subparagraph (B), to verify eligibility for people seeking enrollment and people who certify. (B) The information may include: (i) Medicaid information supplied under arrangements with States to verify eligibility; (ii) financial information supplied under arrangements with the Commissioner of Social Security; and (iii) financial information supplied under Internal Revenue Code section 6103(l)(19) by the Treasury Secretary. (C) Medicaid enrollees. (i) Nothing prevents the Secretary from finding that a discount-card-eligible person in a Medicaid category, including a QMB, SLMB, or certain QI–1 category, meets the income requirement in subsection (b)(2)(A). (ii) As a condition of Federal financial participation under subchapter XIX, a State must provide the Secretary its related information in the required form so the Secretary can identify people described in subsection (b)(1)(B) and people eligible for either type of transitional assistance.
(4) Reconsideration. (A) The Secretary must create a process for a discount-card-eligible person found through certification and verification not to qualify for either type of transitional assistance to request reconsideration. (B) The Secretary may contract for these reconsiderations. (C) The result must be communicated to the person and the sponsor.
(g) Transitional assistance
(1) An eligible person enrolled with an endorsed program is entitled (A) to have the Secretary pay any annual enrollment fee charged under subsection (c)(2); and (B) to have the program pay, up to paragraph (2)’s limit, 90 percent of the cost of covered discount-card drugs obtained through the program, considering the negotiated price. For a special eligible person, the percentage is 95 percent.
(2) Dollar limit. (A) Subject to (B), the limit is $600 for 2004. For 2005, it is $600 plus, except as provided in subparagraph (E), the amount of the person’s 2004 limit that exceeds the 2004 payment under paragraph (1)(B). (B) The Secretary may prorate the limit for the remaining part of a year, except for a person who, for 2004, enrolled and certified before the initial implementation date, or who, for 2005, was enrolled and had certified before February 1, 2005. (C) If an eligible person changes programs, the Secretary must provide the new sponsor information about the person’s remaining amount. (D) No assistance under paragraph (1)(B) covers a covered drug dispensed after December 31, 2005. (E) Unless the Secretary provides an exceptional case, a person who voluntarily leaves an endorsed plan does not carry over the unused 2004 amount into the 2005 calculation.
(3) The Secretary must provide a method to reimburse sponsors for assistance under this subsection.
(4) Coinsurance. (A) A pharmacy may reduce or waive the coinsurance under paragraph (1)(B) as allowed by section 1320a–7b(b)(3)(G). (B) (i) The Secretary must arrange for a State to pay some or all of that coinsurance for enrollees as the State specifies, directly to the pharmacy. (ii) Those State payments are not State expenditures for Medicaid or SCHIP Federal matching. (iii) The coinsurance is not treated as Medicare coinsurance for section 1396d(p)(3)(B). (C) Coinsurance, whether paid or waived, does not count toward the paragraph (2) dollar limit.
(5) Access for long-term-care residents and American Indians. (A) The Secretary must establish procedures and may waive requirements as needed to negotiate sponsor arrangements with pharmacies supporting long-term-care facilities, so eligible residents can receive transitional assistance. (B) The Secretary must establish procedures and may waive requirements to ensure that, for transitional assistance, pharmacies operated by the Indian Health Service, Indian tribes and tribal organizations, and urban Indian organizations defined in section 1603 of title 25 have an opportunity to join the networks of at least two endorsed programs in each State and the District of Columbia where such a pharmacy operates.
(6) Negotiated prices and transitional assistance do not count as benefits when deciding eligibility for, or the amount of benefits under, another Federal program.
(7) Differences in benefits caused by this section, including giving or not giving assistance and paying or waiving a fee, are disregarded when applying section 1395w–24(f).
(h) Sponsor qualification, endorsement, and beneficiary protections
(1) (A) “Prescription drug card sponsor” and “sponsor” mean a nongovernmental entity the Secretary finds appropriate to offer an endorsed program. This may include (i) a pharmaceutical benefit-management company; (ii) a wholesale or retail pharmacy delivery system; (iii) an insurer, including one offering Medicare supplemental policies under section 1395ss; (iv) an organization offering a part C plan; or (v) a combination of those entities. (B) Each program must be operated by one or more entities, directly or through an affiliate, with demonstrated experience and expertise operating that or a similar program and meeting business-stability and integrity requirements set by the Secretary. (C) The sponsor must have arrangements satisfactory to the Secretary for accounting for assistance provided under subsection (g).
(2) Applications. (A) A sponsor seeking endorsement must submit an application at the time and in the manner the Secretary requires, with required information. (B) The Secretary reviews it and may endorse the program only if (i) the program and sponsor comply with this section’s applicable requirements and (ii) the sponsor has a contract with the Secretary to carry them out. (C) Endorsement and contract last for the program’s duration, including any transition under subsection (a)(2)(C)(ii), but the Secretary may terminate them with notice and for cause as defined by the Secretary. (D) (i) The Secretary must make at least two endorsed programs available to each eligible person, each from a different sponsor. (ii) The Secretary may limit the number of contracted sponsors in a State, but not below two.
(3) Except under paragraph (9), if a sponsor enrolls people from any part of a State, it must allow every eligible person in any part of that State to enroll.
(4) A sponsor must pass negotiated prices for covered drugs, including pharmacy and manufacturer discounts, to enrolled eligible people to the extent disclosed under subsection (i)(1).
(5) Each sponsor must provide meaningful procedures, similar to section 1395w–22(f), for hearing and resolving grievances between the sponsor or its program agents and enrollees.
(6) (A) For this program, operating an endorsed program is a covered function and a sponsor is a covered entity under part C of subchapter XI and its regulations, including privacy regulations issued under HIPAA section 264(c) (42 U.S.C. 1320d–2 note). (B) To encourage sponsors to participate, the Secretary may waive relevant privacy regulations for an appropriate limited period.
(7) A sponsor may provide under the program only (A) a product or service directly related to a covered discount-card drug, or (B) a discount price for nonprescription drugs. Subject to paragraph (6), it may market a product or service only if it directly relates to a covered drug, or to a nonprescription drug described in (A)(ii) and the marketing gives information about that drug’s discounted price.
(8) Each program must meet additional requirements the Secretary identifies to protect eligible people, including ensuring that an enrollee is charged no more than the lower of the negotiated-price amount or the usual and customary price.
(9) Special rules. (A) An organization offering a part C plan or enrollment under a section 1395mm(h) reasonable-cost contract may elect the rules in (B) for enrollees in its qualifying plan or contract and its endorsed program, but only if the program is limited to those enrollees. (B) (i) Enrollment is limited to eligible people enrolled in the involved part C plan or contract, and the sponsor may not enroll others. (ii) Pharmacy-access requirements under subsection (e)(1)(B) are treated as met if access is through a non-mail-order pharmacy network approved by the Secretary. (iii) The Secretary may waive sponsor requirements that are duplicative, conflict with the organization’s part C or section 1395mm requirements, or are needed to coordinate this program with those benefits.
(i) Disclosure and oversight
(1) Each sponsor must disclose, as the Secretary requires, information about program performance, enrolled people’s drug use, and how much manufacturer price concessions described in subsection (e)(1)(A)(ii) are passed to enrollees through pharmacies or otherwise, plus other information the Secretary requires. Section 1396r–8(b)(3)(D) applies to reported drug-pricing data except aggregate data.
(2) The Secretary must oversee compliance. The Secretary may audit and inspect a sponsor’s, and an affiliate’s, books and records concerning the program, including amounts payable under this section.
(3) The Secretary may impose intermediate sanctions or revoke endorsement if a sponsor or program no longer meets requirements or used false or misleading marketing. The Secretary may impose a civil money penalty up to $10,000 for conduct a party knows or should know violates this section. Section 1320a–7a, except subsections (a), (b), and the second sentence of (f), applies to that penalty as it applies to a penalty or proceeding under section 1320a–7a(a).
(j) Territories
(1) The Secretary may waive any provision, including subsection (h)(2)(D), for a resident of a State other than the 50 States and the District of Columbia when necessary to secure negotiated-price access for eligible people, or, at the Secretary’s option, people described in subsection (b)(1)(A)(i).
(2) Transitional assistance. (A) If such a State establishes the plan in (B), the Secretary must pay the State, throughout this section’s operation, the amount allotted under (C). (B) The plan must (i) provide transitional assistance for covered discount-card drugs to some or all State residents who are entitled to part A benefits or enrolled under part B and whose income is below 135 percent of the poverty line, and (ii) ensure the money is used only for that assistance. (C) The State’s allotment equals $35,000,000 multiplied by the ratio of (i) the number of part A beneficiaries and part B enrollees living in that State, as determined July 1, 2003, to (ii) the total of those numbers for all covered States, with the Secretary estimating the numbers. (D) Unused amounts are added to the amount available to the State for section 1396u–5(e).
(k) Funding
(1) Transitional Assistance Account. (A) An account called the “Transitional Assistance Account” is created within the Federal Supplementary Medical Insurance Trust Fund established by section 1395t. (B) It consists of gifts and bequests allowed by section 401(i)(1), interest earned on its balances, and amounts deposited or appropriated under this subsection. (C) Money provided under this subsection must be kept separate from the rest of that Trust Fund, but invested and redeemed in the same way as the Trust Fund’s other money and investments.
(2) Payments. (A) The Managing Trustee must periodically pay from the Account amounts the Secretary certifies are needed for transitional assistance under subsections (g) and (j)(2). (B) Account amounts are not counted when computing actuarial rates or part B premiums under section 1395r.
(3) For each fiscal year, money is appropriated to the Account from otherwise unappropriated Treasury money in an amount equal to that year’s Account payments.
(4) Congress authorizes appropriations to the Secretary of amounts needed for the Secretary’s duties under this section.
(5) After the Secretary decides the Account is no longer needed for this program, its remaining balance must be transferred to and deposited in the Medicare Prescription Drug Account* under section 1395w–116.
(6) This section does not authorize paying a sponsor for its administrative expenses, including administering subsections (f) and (g), except that the Secretary may pay an enrollment fee on behalf of a transitional-assistance-eligible person under subsection (g)(1)(A).
The Secretary* shall establish a program under this section—
to endorse prescription drug* discount card programs that meet the requirements of this section in order to provide access to prescription drug discounts through prescription drug card sponsors for discount card eligible individuals throughout the United States*; and
to provide for transitional assistance for transitional assistance eligible individuals enrolled in such endorsed programs.
The Secretary shall implement the program under this section so that discount cards and transitional assistance are first available by not later than 6 months after December 8, 2003.
The Secretary shall promulgate regulations* to carry out the program under this section which may be effective and final immediately on an interim basis as of the date of publication of the interim final regulation. If the Secretary provides for an interim final regulation, the Secretary shall provide for a period of public comments on such regulation after the date of publication. The Secretary may change or revise such regulation after completion of the period of public comment.
Subject to clause (ii)—
the program under this section shall not apply to covered discount card drugs dispensed after December 31, 2005; and
transitional assistance shall be available after such date to the extent the assistance relates to drugs dispensed on or before such date.
In the case of an individual who is enrolled in an endorsed discount card program as of December 31, 2005, during the individual’s transition period (if any) under clause (iii), in accordance with transition rules specified by the Secretary—
such endorsed program may continue to apply to covered discount card drugs dispensed to the individual under the program during such transition period;
no annual enrollment fee shall be applicable during the transition period;
during such period the individual may not change the endorsed program plan in which the individual is enrolled; and
the balance of any transitional assistance remaining on January 1, 2006, shall remain available for drugs dispensed during the individual’s transition period.
The transition period under this clause for an individual is the period beginning on January 1, 2006, and ending in the case of an individual who—
is enrolled in a prescription drug plan* or an MA–PD plan* before the last date of the initial enrollment period under section 1395w–101(b)(2)(A) of this title, on the effective date of the individual’s coverage under such part; or
is not so enrolled, on the last day of such initial period.
Nothing in this section shall be construed as requiring a discount card eligible individual to enroll in an endorsed discount card program under this section.
For purposes of this section:
The term “covered discount card drug” has the meaning given the term “covered part D drug*” in section 1395w–102(e) of this title.
The term “discount card eligible individual” is defined in subsection (b)(1)(A).
The terms “endorsed discount card program” and “endorsed program” mean a prescription drug discount card program that is endorsed (and for which the sponsor has a contract with the Secretary) under this section.
Negotiated prices are described in subsection (e)(1)(A)(ii).
The terms “prescription drug card sponsor” and “sponsor” are defined in subsection (h)(1)(A).
The term “State” has the meaning given such term for purposes of subchapter XIX.
The term “transitional assistance eligible individual” is defined in subsection (b)(2).
For purposes of this section:
The term “discount card eligible individual” means an individual who—
is entitled to benefits, or enrolled, under part A or enrolled under part B; and
subject to paragraph (4), is not an individual described in subparagraph (B).
An individual described in this subparagraph is an individual described in subparagraph (A)(i) who is enrolled under subchapter XIX (or under a waiver under section 1315 of this title of the requirements of such subchapter) and is entitled to any medical assistance for outpatient prescribed drugs described in section 1396d(a)(12) of this title.
Subject to subparagraph (B), the term “transitional assistance eligible individual” means a discount card eligible individual who resides in one of the 50 States or the District of Columbia and whose income (as determined under subsection (f)(1)(B)) is not more than 135 percent of the poverty line* (as defined in section 9902(2) of this title, including any revision required by such section) applicable to the family size involved (as determined under subsection (f)(1)(B)).
Such term does not include an individual who has coverage of, or assistance for, covered discount card drugs under any of the following:
A group health plan* or health insurance coverage* (as such terms are defined in section 300gg–91 of this title), other than coverage under a plan under part C and other than coverage consisting only of excepted benefits (as defined in such section).
Chapter 55 of title 10 (relating to medical and dental care for members of the uniformed services).
A plan under chapter 89 of title 5 (relating to the Federal employees’ health benefits program).
The term “special transitional assistance eligible individual” means a transitional assistance eligible individual whose income (as determined under subsection (f)(1)(B)) is not more than 100 percent of the poverty line (as defined in section 9902(2) of this title, including any revision required by such section) applicable to the family size involved (as determined under subsection (f)(1)(B)).
For purposes of this section, the Secretary shall provide for appropriate rules for the treatment of medically needy individuals described in section 1396a(a)(10)(C) of this title as discount card eligible individuals and as transitional assistance eligible individuals.
The Secretary shall establish a process through which a discount card eligible individual is enrolled and disenrolled in an endorsed discount card program under this section consistent with the following:
Subject to the succeeding provisions of this paragraph and subsection (h)(9), a discount card eligible individual who is not enrolled in an endorsed discount card program and is residing in a State may enroll in any such endorsed program—
that serves residents of the State; and
at any time beginning on the initial enrollment date, specified by the Secretary, and before January 1, 2006.
An enrollment in an endorsed program shall only be effected through completion of a standard enrollment form specified by the Secretary. Each sponsor of an endorsed program shall transmit to the Secretary (in a form and manner specified by the Secretary) information on individuals who complete such enrollment forms and, to the extent provided under subsection (f), information regarding certification as a transitional assistance eligible individual.
Subject to clauses (ii) and (iii), a discount card eligible individual may be enrolled in only one endorsed discount card program under this section.
The Secretary shall establish a process, similar to (and coordinated with) the process for annual, coordinated elections under section 1395w–21(e)(3) of this title during 2004, under which an individual enrolled in an endorsed discount card program may change the endorsed program in which the individual is enrolled for 2005.
The Secretary shall permit an individual to change the endorsed discount card program in which the individual is enrolled in the case of an individual who changes residence to be outside the service area of such program and in such other exceptional cases as the Secretary may provide (taking into account the circumstances for special election periods under section 1395w–21(e)(4) of this title). Under the previous sentence, the Secretary may consider a change in residential setting (such as placement in a nursing facility) or enrollment in or disenrollment from a plan under part C through which the individual was enrolled in an endorsed program to be an exceptional circumstance.
An individual may voluntarily disenroll from an endorsed discount card program at any time. In the case of such a voluntary disenrollment, the individual may not enroll in another endorsed program, except under such exceptional circumstances as the Secretary may recognize under subparagraph (C)(iii) or during the annual coordinated enrollment period provided under subparagraph (C)(ii).
An individual who is enrolled in an endorsed discount card program and not a transitional assistance eligible individual may be disenrolled by the sponsor of the program if the individual fails to pay any annual enrollment fee required under the program.
In the case of a discount card eligible individual who is enrolled in a plan described in section 1395w–21(a)(2)(A) of this title or under a reasonable cost reimbursement contract under section 1395mm(h) of this title that is offered by an organization that also is a prescription discount card sponsor that offers an endorsed discount card program under which the individual may be enrolled and that has made an election to apply the special rules under subsection (h)(9)(B) for such an endorsed program, the individual may only enroll in such an endorsed discount card program offered by that sponsor.
Subject to the succeeding provisions of this paragraph, a prescription drug card sponsor may charge an annual enrollment fee for each discount card eligible individual enrolled in an endorsed discount card program offered by such sponsor. The annual enrollment fee for either 2004 or 2005 shall not be prorated for portions of a year. There shall be no annual enrollment fee for a year after 2005.
No annual enrollment fee charged under subparagraph (A) may exceed $30.
A prescription drug card sponsor shall ensure that the annual enrollment fee (if any) for an endorsed discount card program is the same for all discount card eligible individuals enrolled in the program and residing in the State.
The annual enrollment fee (if any) charged for enrollment in an endorsed program shall be collected by the sponsor of the program.
Under subsection (g)(1)(A), the annual enrollment fee (if any) otherwise charged under this paragraph with respect to a transitional assistance eligible individual shall be paid by the Secretary on behalf of such individual.
The Secretary shall establish an arrangement under which a State may provide for payment of some or all of the enrollment fee for some or all enrollees who are not transitional assistance eligible individuals in the State, as specified by the State under the arrangement. Insofar as such a payment arrangement is made with respect to an enrollee, the amount of the enrollment fee shall be paid directly by the State to the sponsor.
Expenditures made by a State for enrollment fees described in clause (i) shall not be treated as State expenditures for purposes of Federal matching payments under subchapter XIX or XXI.
The Secretary shall provide special rules in the case of payment of an annual enrollment fee for a discount card eligible individual who changes the endorsed program in which the individual is enrolled during a year.
Each prescription drug card sponsor of an endorsed discount card program shall issue, in a standard format specified by the Secretary, to each discount card eligible individual enrolled in such program a card that establishes proof of enrollment and that can be used in a coordinated manner to identify the sponsor, program, and individual for purposes of the program under this section.
In the case of a discount card eligible individual who enrolls in an endorsed program, access to negotiated prices and transitional assistance, if any, under such endorsed program shall take effect on such date as the Secretary shall specify.
The Secretary shall provide for activities under this subsection to broadly disseminate information to discount card eligible individuals (and prospective eligible individuals) regarding—
enrollment in endorsed discount card programs; and
the features of the program under this section, including the availability of transitional assistance.
In order to promote informed choice among endorsed prescription drug discount card programs, the Secretary shall provide for the dissemination of information which—
compares the annual enrollment fee and other features of such programs, which may include comparative prices for covered discount card drugs; and
includes educational materials on the variability of discounts on prices of covered discount card drugs under an endorsed program.
The dissemination of information under clause (i) shall, to the extent practicable, be coordinated with the dissemination of educational information on other medicare options.
To the extent practicable, the Secretary shall ensure, through the activities described in subparagraphs (A) and (B), that discount card eligible individuals are provided with such information at least 30 days prior to the initial enrollment date specified under subsection (c)(1)(A)(ii).
The Secretary shall provide through the toll-free telephone number 1–800–MEDICARE for the receipt and response to inquiries and complaints concerning the program under this section and endorsed programs.
Each prescription drug card sponsor that offers an endorsed discount card program shall make available to discount card eligible individuals (through the Internet and otherwise) information that the Secretary identifies as being necessary to promote informed choice among endorsed discount card programs by such individuals, including information on enrollment fees and negotiated prices for covered discount card drugs charged to such individuals.
Each sponsor offering an endorsed discount card program shall have a mechanism (including a toll-free telephone number) for providing upon request specific information (such as negotiated prices and the amount of transitional assistance remaining available through the program) to discount card eligible individuals enrolled in the program. The sponsor shall inform transitional assistance eligible individuals enrolled in the program of the availability of such toll-free telephone number to provide information on the amount of available transitional assistance.
Each sponsor offering an endorsed discount card program shall have a mechanism so that information on the amount of transitional assistance remaining under subsection (g)(1)(B) is available (electronically or by telephone) at the point-of-sale of covered discount card drugs.
A prescription drug card sponsor offering an endorsed discount card program shall provide that each pharmacy that dispenses a covered discount card drug shall inform a discount card eligible individual enrolled in the program of any differential between the price of the drug to the enrollee and the price of the lowest priced generic covered discount card drug under the program that is therapeutically equivalent and bioequivalent and available at such pharmacy.
Subject to clause (ii), the information under subparagraph (A) shall be provided at the time of purchase of the drug involved, or, in the case of dispensing by mail order, at the time of delivery of such drug.
The Secretary may waive clause (i) in such circumstances as the Secretary may specify.
Each prescription drug card sponsor that offers an endorsed discount card program shall provide each discount card eligible individual enrolled in the program with access to negotiated prices.
For purposes of this section, negotiated prices shall take into account negotiated price concessions, such as discounts, direct or indirect subsidies, rebates, and direct or indirect remunerations, for covered discount card drugs, and include any dispensing fees for such drugs.
Each prescription drug card sponsor offering an endorsed discount card program shall secure the participation in its network of a sufficient number of pharmacies that dispense (other than solely by mail order) drugs directly to enrollees to ensure convenient access to covered discount card drugs at negotiated prices (consistent with rules established by the Secretary). The Secretary shall establish convenient access rules under this clause that are no less favorable to enrollees than the standards for convenient access to pharmacies included in the statement of work of solicitation (#MDA906–03–R–0002) of the Department of Defense under the TRICARE Retail Pharmacy (TRRx) as of March 13, 2003.
Subject to clause (ii), a prescription drug card sponsor (and any pharmacy contracting with such sponsor for the provision of covered discount card drugs to individuals enrolled in such sponsor’s endorsed discount card program) may not charge an enrollee any amount for any items and services required to be provided by the sponsor under this section.
Nothing in clause (i) shall be construed to prevent—
the sponsor from charging the annual enrollment fee (except in the case of a transitional assistance eligible individual); and
the pharmacy dispensing the covered discount card drug, from imposing a charge (consistent with the negotiated price) for the covered discount card drug dispensed, reduced by the amount of any transitional assistance made available.
The prices negotiated from drug manufacturers for covered discount card drugs under an endorsed discount card program under this section shall (notwithstanding any other provision of law) not be taken into account for the purposes of establishing the best price under section 1396r–8(c)(1)(C) of this title.
Each endorsed discount card program shall implement a system to reduce the likelihood of medication errors and adverse drug interactions and to improve medication use.
The determination of whether an individual is a discount card eligible individual or a transitional assistance eligible individual or a special transitional assistance eligible individual (as defined in subsection (b)) shall be determined under procedures specified by the Secretary consistent with this subsection.
For purposes of this section, the Secretary shall define the terms “income” and “family size” and shall specify the methods and period for which they are determined. If under such methods income or family size is determined based on the income or family size for prior periods of time, the Secretary shall permit (whether through a process of reconsideration or otherwise) an individual whose income or family size has changed to elect to have eligibility for transitional assistance determined based on income or family size for a more recent period.
Under the procedures specified under paragraph (1)(A) an individual who wishes to be treated as a transitional assistance eligible individual or a special transitional assistance eligible individual under this section (or another qualified person* on such individual’s behalf) shall certify on the enrollment form under subsection (c)(1)(B) (or similar form specified by the Secretary), through a simplified means specified by the Secretary and under penalty of perjury or similar sanction for false statements, as to the amount of the individual’s income, family size, and individual’s prescription drug coverage (if any) insofar as they relate to eligibility to be a transitional assistance eligible individual or a special transitional assistance eligible individual. Such certification shall be deemed as consent to verification of respective eligibility under paragraph (3). A certification under this paragraph may be provided before, on, or after the time of enrollment under an endorsed program.
The Secretary shall treat a certification under subparagraph (A) that is verified under paragraph (3) as a determination that the individual involved is a transitional assistance eligible individual or special transitional assistance eligible individual (as the case may be) for the entire period of the enrollment of the individual in any endorsed program.
The Secretary shall establish methods (which may include the use of sampling and the use of information described in subparagraph (B)) to verify eligibility for individuals who seek to enroll in an endorsed program and for individuals who provide a certification under paragraph (2).
The information described in this subparagraph is as follows:
Information on eligibility under subchapter XIX and provided to the Secretary under arrangements between the Secretary and States in order to verify the eligibility of individuals who seek to enroll in an endorsed program and of individuals who provide certification under paragraph (2).
Financial information made available to the Secretary under arrangements between the Secretary and the Commissioner of Social Security in order to verify the eligibility of individuals who provide such certification.
Financial information made available to the Secretary under section 6103(l)(19) of the Internal Revenue Code of 1986 in order to verify the eligibility of individuals who provide such certification.
Nothing in this section shall be construed as preventing the Secretary from finding that a discount card eligible individual meets the income requirements under subsection (b)(2)(A) if the individual is within a category of discount card eligible individuals who are enrolled under subchapter XIX (such as qualified medicare beneficiaries (QMBs), specified low-income medicare beneficiaries (SLMBs), and certain qualified individuals (QI–1s)).
As a condition of provision of Federal financial participation to a State that is one of the 50 States or the District of Columbia under subchapter XIX, for purposes of carrying out this section, the State shall provide the information it submits to the Secretary relating to such subchapter in a manner specified by the Secretary that permits the Secretary to identify individuals who are described in subsection (b)(1)(B) or are transitional assistance eligible individuals or special transitional assistance eligible individuals.
The Secretary shall establish a process under which a discount card eligible individual, who is determined through the certification and verification methods under paragraphs (2) and (3) not to be a transitional assistance eligible individual or a special transitional assistance eligible individual, may request a reconsideration of the determination.
The Secretary may enter into a contract to perform the reconsiderations requested under subparagraph (A).
Under the process under subparagraph (A) the results of such reconsideration shall be communicated to the individual and the prescription drug card sponsor involved.
An individual who is a transitional assistance eligible individual (as determined under this section) and who is enrolled with an endorsed program is entitled—
to have payment made of any annual enrollment fee charged under subsection (c)(2) for enrollment under the program; and
to have payment made, up to the amount specified in paragraph (2), under such endorsed program of 90 percent (or 95 percent in the case of a special transitional assistance eligible individual) of the costs incurred for covered discount card drugs obtained through the program taking into account the negotiated price (if any) for the drug under the program.
Subject to subparagraph (B), the amount specified in this paragraph for a transitional assistance eligible individual—
for costs incurred during 2004, is $600; or
for costs incurred during 2005, is—
$600, plus
except as provided in subparagraph (E), the amount by which the amount available under this paragraph for 2004 for that individual exceeds the amount of payment made under paragraph (1)(B) for that individual for costs incurred during 2004.
In the case of an individual not described in clause (ii) with respect to a year, the Secretary may prorate the amount specified in subparagraph (A) for the balance of the year involved in a manner specified by the Secretary.
An individual described in this clause is a transitional assistance eligible individual who—
with respect to 2004, enrolls in an endorsed program, and provides a certification under subsection (f)(2), before the initial implementation date of the program under this section; and
with respect to 2005, is enrolled in an endorsed program, and has provided such a certification, before February 1, 2005.
In the case of a transitional assistance eligible individual who changes the endorsed discount card program in which the individual is enrolled under this section, the Secretary shall provide a process under which the Secretary provides to the sponsor of the endorsed program in which the individual enrolls information concerning the balance of amounts available on behalf of the individual under this paragraph.
Pursuant to subsection (a)(2)(C), no assistance shall be provided under paragraph (1)(B) with respect to covered discount card drugs dispensed after December 31, 2005.
Except in such exceptional cases as the Secretary may provide, in the case of a transitional assistance eligible individual who voluntarily disenrolls from an endorsed plan, the provisions of subclause (II) of subparagraph (A)(ii) shall not apply.
The Secretary shall provide a method for the reimbursement of prescription drug card sponsors for assistance provided under this subsection.
Nothing in this section shall be construed as precluding a pharmacy from reducing or waiving the application of coinsurance imposed under paragraph (1)(B) in accordance with section 1320a–7b(b)(3)(G) of this title.
The Secretary shall establish an arrangement under which a State may provide for payment of some or all of the coinsurance under paragraph (1)(B) for some or all enrollees in the State, as specified by the State under the arrangement. Insofar as such a payment arrangement is made with respect to an enrollee, the amount of the coinsurance shall be paid directly by the State to the pharmacy involved.
Expenditures made by a State for coinsurance described in clause (i) shall not be treated as State expenditures for purposes of Federal matching payments under subchapter XIX or XXI.
Coinsurance described in paragraph (1)(B) shall not be treated as coinsurance under this subchapter for purposes of section 1396d(p)(3)(B) of this title.
The amount of any coinsurance imposed under paragraph (1)(B), whether paid or waived under this paragraph, shall not be taken into account in applying the limitation in dollar amount under paragraph (2).
The Secretary shall establish procedures and may waive requirements of this section as necessary to negotiate arrangements with sponsors to provide arrangements with pharmacies that support long-term care facilities in order to ensure access to transitional assistance for transitional assistance eligible individuals who reside in long-term care facilities.
The Secretary shall establish procedures and may waive requirements of this section to ensure that, for purposes of providing transitional assistance, pharmacies operated by the Indian Health Service, Indian tribes and tribal organizations, and urban Indian organizations (as defined in section 1603 of title 25) have the opportunity to participate in the pharmacy networks of at least two endorsed programs in each of the 50 States and the District of Columbia where such a pharmacy operates.
The availability of negotiated prices or transitional assistance under this section shall not be treated as benefits or otherwise taken into account in determining an individual’s eligibility for, or the amount of benefits under, any other Federal program.
Nonuniformity of benefits resulting from the implementation of this section (including the provision or nonprovision of transitional assistance and the payment or waiver of any enrollment fee under this section) shall not be taken into account in applying section 1395w–24(f) of this title.
For purposes of this section, the terms “prescription drug card sponsor” and “sponsor” mean any nongovernmental entity that the Secretary determines to be appropriate to offer an endorsed discount card program under this section, which may include—
a pharmaceutical benefit management company;
a wholesale or retail pharmacy delivery system;
an insurer (including an insurer that offers medicare supplemental policies under section 1395ss of this title);
an organization offering a plan under part C; or
any combination of the entities described in clauses (i) through (iv).
Each endorsed discount card program shall be operated directly, or through arrangements with an affiliated organization (or organizations), by one or more entities that have demonstrated experience and expertise in operating such a program or a similar program and that meets such business stability and integrity requirements as the Secretary may specify.
The sponsor of an endorsed discount card program shall have arrangements satisfactory to the Secretary to account for the assistance provided under subsection (g) on behalf of transitional assistance eligible individuals.
Each prescription drug card sponsor that seeks endorsement of a prescription drug discount card program under this section shall submit to the Secretary, at such time and in such manner as the Secretary may specify, an application containing such information as the Secretary may require.
The Secretary shall review the application submitted under subparagraph (A) and shall determine whether to endorse the prescription drug discount card program. The Secretary may not endorse such a program unless—
the program and prescription drug card sponsor offering the program comply with the applicable requirements under this section; and
the sponsor has entered into a contract with the Secretary to carry out such requirements.
An endorsement of an endorsed program and a contract under subparagraph (B) shall be for the duration of the program under this section (including any transition applicable under subsection (a)(2)(C)(ii)), except that the Secretary may, with notice and for cause (as defined by the Secretary), terminate such endorsement and contract.
The Secretary shall ensure that there is available to each discount card eligible individual a choice of at least 2 endorsed programs (each offered by a different sponsor).
The Secretary may limit (but not below 2) the number of sponsors in a State that are awarded contracts under this paragraph.
Except as provided in paragraph (9), if a prescription drug card sponsor that offers an endorsed program enrolls in the program individuals residing in any part of a State, the sponsor must permit any discount card eligible individual residing in any portion of the State to enroll in the program.
Each prescription drug card sponsor that offers an endorsed discount card program shall pass on to discount card eligible individuals enrolled in the program negotiated prices on covered discount card drugs, including discounts negotiated with pharmacies and manufacturers, to the extent disclosed under subsection (i)(1).
Each prescription drug card sponsor shall provide meaningful procedures for hearing and resolving grievances between the sponsor (including any entity or individual through which the sponsor carries out the endorsed discount card program) and enrollees in endorsed discount card programs of the sponsor under this section in a manner similar to that required under section 1395w–22(f) of this title.
For purposes of the program under this section, the operations of an endorsed program are covered functions and a prescription drug card sponsor is a covered entity for purposes of applying part C of subchapter XI and all regulatory provisions promulgated thereunder, including regulations (relating to privacy) adopted pursuant to the authority of the Secretary under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d–2 note).1
In order to promote participation of sponsors in the program under this section, the Secretary may waive such relevant portions of regulations relating to privacy referred to in subparagraph (A), for such appropriate, limited period of time, as the Secretary specifies.
The sponsor of an endorsed discount card program—
may provide under the program—
a product or service only if the product or service is directly related to a covered discount card drug; or
a discount price for nonprescription drugs; and
may, to the extent otherwise permitted under paragraph (6) (relating to application of HIPAA requirements), market a product or service under the program only if the product or service is directly related to—
a covered discount card drug; or
a drug described in subparagraph (A)(ii) and the marketing consists of information on the discounted price made available for the drug involved.
Each endorsed discount card program shall meet such additional requirements as the Secretary identifies to protect and promote the interest of discount card eligible individuals, including requirements that ensure that discount card eligible individuals enrolled in endorsed discount card programs are not charged more than the lower of the price based on negotiated prices or the usual and customary price.
In the case of an organization that is offering a plan under part C or enrollment under a reasonable cost reimbursement contract under section 1395mm(h) of this title that is seeking to be a prescription drug card sponsor under this section, the organization may elect to apply the special rules under subparagraph (B) with respect to enrollees in any plan described in section 1395w–21(a)(2)(A) of this title that it offers or under such contract and an endorsed discount card program it offers, but only if it limits enrollment under such program to individuals enrolled in such plan or under such contract.
The special rules under this subparagraph are as follows:
The sponsor limits enrollment under this section under the endorsed discount card program to discount card eligible individuals who are enrolled in the part C plan involved or under the reasonable cost reimbursement contract involved and is not required nor permitted to enroll other individuals under such program.
Pharmacy access requirements under subsection (e)(1)(B) are deemed to be met if the access is made available through a pharmacy network (and not only through mail order) and the network used by the sponsor is approved by the Secretary.
The Secretary may waive the application of such requirements for a sponsor as the Secretary determines to be duplicative or to conflict with a requirement of the organization under part C or section 1395mm of this title (as the case may be) or to be necessary in order to improve coordination of this section with the benefits under such part or section.
Each prescription drug card sponsor offering an endorsed discount card program shall disclose to the Secretary (in a manner specified by the Secretary) information relating to program performance, use of prescription drugs by discount card eligible individuals enrolled in the program, the extent to which negotiated price concessions described in subsection (e)(1)(A)(ii) made available to the entity by a manufacturer are passed through to enrollees through pharmacies or otherwise, and such other information as the Secretary may specify. The provisions of section 1396r–8(b)(3)(D) of this title shall apply to drug pricing data reported under the previous sentence (other than data in aggregate form).
The Secretary shall provide appropriate oversight to ensure compliance of endorsed discount card programs and their sponsors with the requirements of this section. The Secretary shall have the right to audit and inspect any books and records of a prescription discount card sponsor (and of any affiliated organization referred to in subsection (h)(1)(B)) that pertain to the endorsed discount card program under this section, including amounts payable to the sponsor under this section.
The Secretary may implement intermediate sanctions or may revoke the endorsement of a program offered by a sponsor under this section if the Secretary determines that the sponsor or the program no longer meets the applicable requirements of this section or that the sponsor has engaged in false or misleading marketing practices. The Secretary may impose a civil money penalty in an amount not to exceed $10,000 for conduct that a party knows or should know is a violation of this section. The provisions of section 1320a–7a of this title (other than subsections (a) and (b) and the second sentence of subsection (f)) shall apply to a civil money penalty under the previous sentence in the same manner as such provisions apply to a penalty or proceeding under section 1320a–7a(a) of this title.
The Secretary may waive any provision of this section (including subsection (h)(2)(D)) in the case of a resident of a State (other than the 50 States and the District of Columbia) insofar as the Secretary determines it is necessary to secure access to negotiated prices for discount card eligible individuals (or, at the option of the Secretary, individuals described in subsection (b)(1)(A)(i)).
In the case of a State, other than the 50 States and the District of Columbia, if the State establishes a plan described in subparagraph (B) (for providing transitional assistance with respect to the provision of prescription drugs to some or all individuals residing in the State who are described in subparagraph (B)(i)), the Secretary shall pay to the State for the entire period of the operation of this section an amount equal to the amount allotted to the State under subparagraph (C).
The plan described in this subparagraph is a plan that—
provides transitional assistance with respect to the provision of covered discount card drugs to some or all individuals who are entitled to benefits under part A or enrolled under part B, who reside in the State, and who have income below 135 percent of the poverty line; and
assures that amounts received by the State under this paragraph are used only for such assistance.
The amount described in this subparagraph for a State is equal to $35,000,000 multiplied by the ratio (as estimated by the Secretary) of—
the number of individuals who are entitled to benefits under part A or enrolled under part B and who reside in the State (as determined by the Secretary as of July 1, 2003), to
the sum of such numbers for all States to which this paragraph applies.
Amounts made available to a State under this paragraph which are not used under this paragraph shall be added to the amount available to that State for purposes of carrying out section 1396u–5(e) of this title.
There is created within the Federal Supplementary Medical Insurance Trust Fund established by section 1395t of this title an account to be known as the “Transitional Assistance Account” (in this subsection referred to as the “Account”).
The Account shall consist of such gifts and bequests as may be made as provided in section 401(i)(1) of this title, accrued interest on balances in the Account, and such amounts as may be deposited in, or appropriated to, the Account as provided in this subsection.
Funds provided under this subsection to the Account shall be kept separate from all other funds within the Federal Supplementary Medical Insurance Trust Fund, but shall be invested, and such investments redeemed, in the same manner as all other funds and investments within such Trust Fund.
The Managing Trustee shall pay from time to time from the Account such amounts as the Secretary certifies are necessary to make payments for transitional assistance provided under subsections (g) and (j)(2).
Amounts payable from the Account shall not be taken into account in computing actuarial rates or premium amounts under section 1395r of this title.
There are appropriated to the Account in a fiscal year, out of any moneys in the Treasury not otherwise appropriated, an amount equal to the payments made from the Account in the year.
There are authorized to be appropriated to the Secretary such sums as may be necessary to carry out the Secretary’s responsibilities under this section.
Any balance remaining in the Account after the Secretary determines that funds in the Account are no longer necessary to carry out the program under this section shall be transferred and deposited into the Medicare Prescription Drug Account under section 1395w–116 of this title.
Nothing in this section shall be construed as authorizing the Secretary to provide for payment (other than payment of an enrollment fee on behalf of a transitional assistance eligible individual under subsection (g)(1)(A)) to a sponsor for administrative expenses incurred by the sponsor in carrying out this section (including in administering the transitional assistance provisions of subsections (f) and (g)).
Source credit: (Aug. 14, 1935, ch. 531, title XVIII, § 1860D–31, as added Pub. L. 108–173, title I, § 101(a)(2), Dec. 8, 2003, 117 Stat. 2131.)
- 1935Enacted · Pub. L. 108-173 · 117 Stat. 2131
A history note hasn’t been published yet. The record shows enactment by Pub. L. 108-173 on 1935-08-14.
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