r/title-42-THE-PUBLIC-HEALTH-AND-WELFARE wiki — defined terms
The statute’s own glossary: every term Title 42 defines, in section order.
“initial residency period” applies in that section
The term “initial residency period” means the period of board eligibility, except that— (i) except as provided in clause (ii), in no case shall the initial period of residency exceed an aggregate period of formal training of more than five years for any individual, and (ii) a period, of not more than two years, during which an individual is in a geriatric residency or fellowship program or a preventive medicine residency or fellowship program which meets such criteria as the Secretary may establish, shall be treated as part of the initial residency period, but shall not be counted against any limitation on the initial residency period.
“inpatient hospital code” applies throughout its subchapter
the term “inpatient hospital code” means any code that is used with respect to inpatient hospital services for which payment may be made under this subsection and includes an alphanumeric code issued under the International Classification of Diseases, 9th Revision, Clinical Modification (“ICD–9–CM”) and its subsequent revisions. (iv) For purposes of clause (ii)(III),
“large urban area” applies in that section
the term “large urban area” means, with respect to a fiscal year, such an urban area which the Secretary determines (in the publications described in subsection (e)(5) before the fiscal year) has a population of more than 1,000,000 (as determined by the Secretary based on the most recent available population data published by the Bureau of the Census); and
“low-volume hospital” applies in that section
the term “low-volume hospital” means, for a fiscal year or portion of a fiscal year, a subsection (d) hospital (as defined in paragraph (1)(B)) that the Secretary determines is located more than 25 road miles (or, with respect to fiscal years 2011 through 2026 and the portion of fiscal year 2027 beginning on October 1, 2026 , and ending on December 31, 2026 , 15 road miles) from another subsection (d) hospital and has— (I) with respect to each of fiscal years 2005 through 2010, less than 800 discharges during the fiscal year; (II) with respect to each of fiscal years 2011 through 2018, less than 1,600 discharges of individuals entitled to, or enrolled for, benefits under part A during the …
“LTCH discharge payment percentage” applies in that section
the term “LTCH discharge payment percentage” means, with respect to a long-term care hospital for a cost reporting period beginning during or after fiscal year 2020, the ratio (expressed as a percentage) of— (I) the number of Medicare fee-for-service discharges for such hospital and period for which payment is not made at the site neutral payment rate, to (II) the total number of Medicare fee-for-service discharges for such hospital and period. (D) Inclusion of subsection (d) Puerto Rico hospitals In this paragraph, any reference in this paragraph to a subsection (d) hospital shall be deemed to include a reference to a subsection (d) Puerto Rico hospital.
“market basket percentage increase” applies in that section
the term “market basket percentage increase” means, with respect to cost reporting periods and discharges occurring in a fiscal year, the percentage, estimated by the Secretary before the beginning of the period or fiscal year, by which the cost of the mix of goods and services (including personnel costs but excluding nonoperating costs) comprising routine, ancillary, and special care unit inpatient hospital services, based on an index of appropriately weighted indicators of changes in wages and prices which are representative of the mix of goods and services included in such inpatient hospital services, for the period or fiscal year will exceed the cost of such mix of goods and services …
“medicare patient load” applies in that section
the term “medicare patient load” means, with respect to a hospital’s cost reporting period, the fraction of the total number of inpatient-bed-days (as established by the Secretary) during the period which are attributable to patients with respect to whom payment may be made under part A.
“medicare-dependent, small rural hospital” applies throughout its subchapter
The term “medicare-dependent, small rural hospital” means, with respect to any cost reporting period to which clause (i) applies, any hospital— (I) that is located in— (aa) a rural area; or (bb) a State with no rural area (as defined in paragraph (2)(D)) and satisfies any of the criteria in subclause (I), (II), or (III) of paragraph (8)(E)(ii), (II) that has not more than 100 beds, (III) that is not classified as a sole community hospital under subparagraph (D), and (IV) for which not less than 60 percent of its inpatient days or discharges during the cost reporting period beginning in fiscal year 1987, or two of the three most recently audited cost reporting periods for which the Secretary …
“nonprovider setting that is primarily engaged in furnishing patient care” applies in that section
The term “nonprovider setting that is primarily engaged in furnishing patient care” means a nonprovider setting in which the primary activity is the care and treatment of patients, as defined by the Secretary.
“operating costs of inpatient hospital services” applies in that section
the term “operating costs of inpatient hospital services” includes all routine operating costs, ancillary service operating costs, and special care unit operating costs with respect to inpatient hospital services as such costs are determined on an average per admission or per discharge basis (as determined by the Secretary), and includes the costs of all services for which payment may be made under this subchapter that are provided by the hospital (or by an entity wholly owned or operated by the hospital) to the patient during the 3 days (or, in the case of a hospital that is not a subsection (d) hospital, during the 1 day) immediately preceding the date of the patient’s admission if such …
“other services related to the admission” applies in that section
the term “other services related to the admission” includes all services that are not diagnostic services (other than ambulance and maintenance renal dialysis services) for which payment may be made under this subchapter that are provided by a hospital (or an entity wholly owned or operated by the hospital) to a patient— (A) on the date of the patient’s inpatient admission; or (B) during the 3 days (or, in the case of a hospital that is not a subsection (d) hospital, during the 1 day) immediately preceding the date of such admission unless the hospital demonstrates (in a form and manner, and at a time, specified by the Secretary) that such services are not related (as determined by the …
“otherwise applicable resident limit” applies in that section
The term “otherwise applicable resident limit” means, with respect to a hospital, the limit otherwise applicable under subparagraphs (F)(i) and (H) of paragraph (4) on the resident level for the hospital determined without regard to this paragraph.
“payment unit” applies in that section
the term “payment unit” means a discharge. (E) Construction relating to transfer authority Nothing in this subsection shall be construed as preventing the Secretary from providing for an adjustment to payments to take into account the early transfer of a patient from a rehabilitation facility to another site of care.
“payment year” applies in that section
the term “payment year” means a fiscal year beginning with fiscal year 2011. (ii) First, second, etc. payment year
“period of board eligibility” applies in that section
the term “period of board eligibility” means, for a resident, the minimum number of years of formal training necessary to satisfy the requirements for initial board eligibility in the particular specialty for which the resident is training. (ii) Application of 1985–1986 directory Except as provided in clause (iii), the period of board eligibility shall be such period specified in the 1985–1986 Directory of Residency Training Programs published by the Accreditation Council on Graduate Medical Education.
“primary care resident” applies in that section
The term “primary care resident” means a resident enrolled in an approved medical residency training program in family medicine, general internal medicine, general pediatrics, preventive medicine, geriatric medicine, or osteopathic general practice. (I) Resident
“principal finding of neoplastic disease” applies in that section
the term “principal finding of neoplastic disease” means the condition established after study to be chiefly responsible for occasioning the admission of a patient to a hospital, except that only discharges with ICD–9–CM principal diagnosis codes of 140 through 239, V58.0, V58.1, V66.1, V66.2, or 990 will be considered to reflect such a principal diagnosis.
“psychiatry or psychiatry subspecialty residency” applies in that section
The term “psychiatry or psychiatry subspecialty residency” means a residency in psychiatry as accredited by the Accreditation Council for Graduate Medical Education for the purpose of preventing, diagnosing, and treating mental health disorders. (iii) Qualifying hospital
“qualified discharge” applies throughout its subchapter
the term “qualified discharge” means a discharge classified with a diagnosis-related group (described in clause (iii)) of an individual from a subsection (d) hospital, if upon such discharge the individual— (I) is admitted as an inpatient to a hospital or hospital unit that is not a subsection (d) hospital for the provision of inpatient hospital services; (II) is admitted to a skilled nursing facility; (III) is provided home health services from a home health agency, if such services relate to the condition or diagnosis for which such individual received inpatient hospital services from the subsection (d) hospital, and if such services are provided within an appropriate period (as …
“qualified nonhospital providers” applies in that section
the term “qualified nonhospital providers” means— (A) a Federally 15 qualified health center, as defined in section 1395x(aa)(4) of this title ; (B) a rural health clinic, as defined in section 1395x(aa)(2) of this title ; (C) Medicare+Choice organizations; and (D) such other providers (other than hospitals) as the Secretary determines to be appropriate.
“qualifying hospital” applies in that section
The term “qualifying hospital” means a hospital described in any of subclauses (I) through (IV) of subparagraph (B)(ii). (iii) Reference resident level
“readmission” applies in that section
The term “readmission” means, in the case of an individual who is discharged from an applicable hospital, the admission of the individual to the same or another applicable hospital within a time period specified by the Secretary from the date of such discharge. Insofar as the discharge relates to an applicable condition for which there is an endorsed measure described in subparagraph (A)(ii)(I), such time period (such as 30 days) shall be consistent with the time period specified for such measure.
“reference resident level” applies in that section
The term “reference resident level” means, with respect to a hospital, the highest resident level for any of the 3 most recent cost reporting periods (ending before March 23, 2010 ) of the hospital for which a cost report has been settled (or, if not, submitted (subject to audit)), as determined by the Secretary. (ii) Resident level
“region” applies in that section
the term “region” means one of the nine census divisions, comprising the fifty States and the District of Columbia, established by the Bureau of the Census for statistical and reporting purposes;
“rehabilitation innovation centers” applies in that section
the term “rehabilitation innovation centers” means a rehabilitation facility that, as of the applicable date (as defined in clause (v)), is a rehabilitation facility described in clause (iv). (iv) Rehabilitation facility described (I) In general Subject to subclause (II), a rehabilitation facility described in this clause is a rehabilitation facility that— (aa) is classified as a rehabilitation facility under the IRF Rate Setting File for the Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2019 (83 Fed. Reg.
“resident” applies in that section
The term “resident” includes an intern or other participant in an approved medical residency training program. (J) Adjustments for certain family practice residency programs (i) In general In the case of an approved medical residency training program (meeting the requirements of clause (ii)) of a hospital which received funds from the United States, a State, or a political subdivision of a State or an instrumentality of such a State or political subdivision (other than payments under this subchapter or a State plan under subchapter XIX) for the program during the cost reporting period that began during fiscal year 1984, the Secretary shall— (I) provide for an average amount under paragraph …
“resident level” applies in that section
The term “resident level” means, with respect to a hospital, the total number of full-time equivalent residents, before the application of weighting factors (as determined under paragraph (4)), in the fields of allopathic and osteopathic medicine for the hospital. (ii) Otherwise applicable resident limit
“rural area” applies in that section
the term “rural area” means any area outside such an area or similar area. A hospital located in a Metropolitan Statistical Area shall be deemed to be located in the region in which the largest number of the hospitals in the same Metropolitan Statistical Area are located, or, at the option of the Secretary, the region in which the majority of the inpatient discharges (with respect to which payments are made under this subchapter) from hospitals in the same Metropolitan Statistical Area are made.
“second payment year” applies in that section
The terms “second payment year”, “third payment year”, and “fourth payment year” mean, with respect to an eligible hospital, each successive year immediately following the first payment year for that hospital.
“severe wound” applies in that section
the term “severe wound” means a stage 3 wound, stage 4 wound, unstageable wound, non-healing surgical wound, infected wound, fistula, osteomyelitis, or wound with morbid obesity, as identified in the claim from the long-term care hospital.
“site neutral payment rate” applies in that section
the term “site neutral payment rate” means the lower of— (I) the IPPS comparable per diem amount determined under paragraph (d)(4) of section 412.529 of title 42, Code of Federal Regulations, including any applicable outlier payments under section 412.525 of such title; or (II) 100 percent of the estimated cost for the services involved.
“sole community hospital” applies throughout its subchapter
the term “sole community hospital” means any hospital— (I) that the Secretary determines is located more than 35 road miles from another hospital, (II) that, by reason of factors such as the time required for an individual to travel to the nearest alternative source of appropriate inpatient care (in accordance with standards promulgated by the Secretary), location, weather conditions, travel conditions, or absence of other like hospitals (as determined by the Secretary), is the sole source of inpatient hospital services reasonably available to individuals in a geographic area who are entitled to benefits under part A, or (III) that is located in a rural area and designated by the Secretary …
“specified hospital” applies in that section
The term “specified hospital” means a subsection (d) hospital, hospitals described in clauses (i) through (v) of subsection (d)(1)(B) and, as determined feasible and appropriate by the Secretary, other hospitals not otherwise described in this subparagraph.
“subparagraph (L) rebased target amount” applies in that section
the term “subparagraph (L) rebased target amount” has the meaning given the term “target amount” in subparagraph (C), except that— (I) there shall be substituted for the base cost reporting period the 12-month cost reporting period beginning during fiscal year 2006; (II) any reference in subparagraph (C)(i) to the “first cost reporting period” described in such subparagraph is deemed a reference to the first cost reporting period beginning on or after January 1, 2009 ; and (III) the applicable percentage increase shall only be applied under subparagraph (C)(iv) for discharges occurring on or after January 1, 2009 .
“subsection (d) hospital” applies in that section
the term “subsection (d) hospital” means a hospital located in one of the fifty States or the District of Columbia other than— (i) a psychiatric hospital (as defined in section 1395x(f) of this title ), (ii) a rehabilitation hospital (as defined by the Secretary), (iii) a hospital whose inpatients are predominantly individuals under 18 years of age, (iv) a hospital which has an average inpatient length of stay (as determined by the Secretary) of greater than 25 days, (v) (I) a hospital that the Secretary has classified, at any time on or before December 31, 1990 , 3 (or, in the case of a hospital that, as of December 19, 1989 , is located in a State operating a demonstration project under …
“subsection (d) Puerto Rico hospital” applies in that section
the term “subsection (d) Puerto Rico hospital” means a hospital that is located in Puerto Rico and that would be a subsection (d) hospital (as defined in paragraph (1)(B)) if it were located in one of the 50 States. (B) The Secretary shall determine a Puerto Rico adjusted DRG prospective payment rate, for each inpatient hospital discharge in fiscal year 1988 involving inpatient hospital services of a subsection (d) Puerto Rico hospital for which payment may be made under part A of this subchapter.
“target amount” applies in that section
the term “target amount” means, with respect to a hospital for a particular 12-month cost reporting period— (i) in the case of the first such reporting period for which this subsection is in effect, the allowable operating costs of inpatient hospital services (as defined in subsection (a)(4)) recognized under this subchapter for such hospital for the preceding 12-month cost reporting period, and (ii) in the case of a later reporting period, the target amount for the preceding 12-month cost reporting period, increased by the applicable percentage increase under subparagraph (B) for that particular cost reporting period.
“third payment year” applies in that section
The terms “second payment year”, “third payment year”, and “fourth payment year” mean, with respect to an eligible hospital, each successive year immediately following the first payment year for that hospital.
“trended costs” applies in that section
the term “trended costs” means for a hospital cost reporting period ending in a fiscal year— (i) in the case of a hospital for which its cost reporting period ending in fiscal year 1996 was its third or subsequent full cost reporting period for which it receives payments under this subsection, the lesser of the operating costs or target amount for that hospital for its cost reporting period ending in fiscal year 1996, or (ii) in the case of any other hospital, the operating costs for that hospital for its third full cost reporting period for which it receives payments under this subsection, increased (in a compounded manner) for each succeeding fiscal year (through the fiscal year involved) …
“urban area” applies in that section
the term “urban area” means an area within a Metropolitan Statistical Area (as defined by the Office of Management and Budget) or within such similar area as the Secretary has recognized under subsection (a) by regulation;
“wound” applies in that section
the term “wound” means an injury involving division of tissue or rupture of the integument or mucous membrane with exposure to the external environment. (7) Treatment of high cost outlier payments (A) Adjustment to the standard Federal payment rate for estimated high cost outlier payments Under the system described in paragraph (1), for fiscal years beginning on or after October 1, 2017 , the Secretary shall reduce the standard Federal payment rate as if the estimated aggregate amount of high cost outlier payments for standard Federal payment rate discharges for each such fiscal year would be equal to 8 percent of estimated aggregate payments for standard Federal payment rate discharges for …
“MA plan” applies throughout its part
The term “MA plan” has the meaning given such term in section 1395w–28(b)(1) of this title . (C) MA–PD plan
“MA–PD plan” applies throughout its part
The 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 general The 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.
“part D eligible individual” applies throughout its part
The term “part D eligible individual” means an individual who is entitled to benefits under part A or enrolled under part B (but not including an individual enrolled solely for coverage of immunosuppressive drugs under section 1395 o (b) of this title). (B) MA plan
“adult vaccine recommended by the Advisory Committee on Immunization Practices” applies in that section
the term “adult vaccine recommended by the Advisory Committee on Immunization Practices” means a covered part D drug that is a vaccine licensed under section 351 of the Public Health Service Act [ 42 U.S.C. 262 ] for use by adult populations and administered in accordance with recommendations of the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention. (9) Treatment of cost-sharing for covered insulin products (A) No application of deductible For plan year 2023 and subsequent plan years, the deductible under paragraph (1) shall not apply with respect to any covered insulin product.
“applicable copayment amount” applies in that section
the term “applicable copayment amount” means, with respect to a covered insulin product under a prescription drug plan or an MA–PD plan dispensed— (i) during plan years 2023, 2024, and 2025, $35; and (ii) during plan year 2026 and each subsequent plan year, the lesser of— (I) $35; (II) an amount equal to 25 percent of the maximum fair price established for the covered insulin product in accordance with part E of subchapter XI; or (III) an amount equal to 25 percent of the negotiated price of the covered insulin product under the prescription drug plan or MA–PD plan.
“basic prescription drug coverage” applies throughout its part
the term “basic prescription drug coverage” means either of the following: (A) Coverage that meets the requirements of paragraph (1)(A). (B) Coverage that meets the requirements of paragraph (1)(B) but does not have any supplemental prescription drug coverage described in paragraph (2)(A). (4) Application of secondary payor provisions The provisions of section 1395w–22(a)(4) of this title shall apply under this part in the same manner as they apply under part C. (5) Construction Nothing in this subsection shall be construed as changing the computation of incurred costs under subsection (b)(4). (b) Standard prescription drug coverage For purposes of this part and part C,
“covered insulin product” applies in that section
the term “covered insulin product” means an insulin product that is a covered part D drug covered under the prescription drug plan or MA–PD plan that is approved under section 355 of title 21 or licensed under section 351 of the Public Health Service Act [ 42 U.S.C. 262 ] and marketed pursuant to such approval or licensure, including any covered insulin product that has been deemed to be licensed under section 351 of the Public Health Service Act pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 and marketed pursuant to such section. (D) Applicable copayment amount In this paragraph,
“covered part D drug” applies throughout its part
the term “covered part D drug” means— (A) a drug that may be dispensed only upon a prescription and that is described in subparagraph (A)(i), (A)(ii), or (A)(iii) of section 1396r–8(k)(2) of this title ; (B) a biological product described in clauses (i) through (iii) of subparagraph (B) of such section or insulin described in subparagraph (C) of such section and medical supplies associated with the injection of insulin (as defined in regulations of the Secretary); or (C) for the period beginning on December 29, 2022 , and ending on December 31, 2026 , an oral antiviral drug that may be dispensed only upon a prescription and is authorized under section 360bbb–3 of title 21 , on the basis of …
“maximum monthly cap” applies throughout its part
the term “maximum monthly cap” means, with respect to an enrollee— (I) for the first month for which the enrollee has made an election pursuant to clause (i), an amount determined by calculating— (aa) the annual out-of-pocket threshold specified in paragraph (4)(B) minus the incurred costs of the enrollee as described in paragraph (4)(C); divided by (bb) the number of months remaining in the plan year; and (II) for a subsequent month, an amount determined by calculating— (aa) the sum of any remaining out-of-pocket costs owed by the enrollee from a previous month that have not yet been billed to the enrollee and any additional out-of-pocket costs incurred by the enrollee; divided by (bb) the …
“medically accepted indication” applies throughout its part
the term “medically accepted indication” has the meaning given that term— (i) in the case of a covered part D drug used in an anticancer chemotherapeutic regimen, in section 1395x(t)(2)(B) of this title , except that in applying such section— (I) “prescription drug plan or MA–PD plan” shall be substituted for “carrier” each place it appears; and (II) subject to subparagraph (B), the compendia described in section 1396r–8(g)(1)(B)(i)(III) of this title shall be included in the list of compendia described in clause (ii)(I) section 1395x(t)(2)(B) of this title ; and (ii) in the case of any other covered part D drug, in section 1396r–8(k)(6) of this title .
“qualified prescription drug coverage” applies throughout its part
the term “qualified prescription drug coverage” means either of the following: (A) Standard prescription drug coverage with access to negotiated prices Standard prescription drug coverage (as defined in subsection (b)) and access to negotiated prices under subsection (d). (B) Alternative prescription drug coverage with at least actuarially equivalent benefits and access to negotiated prices Coverage of covered part D drugs which meets the alternative prescription drug coverage requirements of subsection (c) and access to negotiated prices under subsection (d), but only if the benefit design of such coverage is approved by the Secretary, as provided under subsection (c).
“standard prescription drug coverage” applies throughout its part
the term “standard prescription drug coverage” means coverage of covered part D drugs that meets the following requirements: (1) Deductible (A) In general Subject to paragraphs (8) and (9), the coverage has an annual deductible— (i) for 2006, that is equal to $250; or (ii) for a subsequent year, that is equal to the amount specified under this paragraph for the previous year increased by the percentage specified in paragraph (6) for the year involved. (B) Rounding Any amount determined under subparagraph (A)(ii) that is not a multiple of $5 shall be rounded to the nearest multiple of $5.
“qualifying plan” applies in that section
the term “qualifying plan” means— (A) a prescription drug plan; or (B) an MA–PD plan described in section 1395w–21(a)(2)(A)(i) of this title that provides— (i) basic prescription drug coverage; or (ii) qualified prescription drug coverage that provides supplemental prescription drug coverage so long as there is no MA monthly supplemental beneficiary premium applied under the plan, due to the application of a credit against such premium of a rebate under section 1395w–24(b)(1)(C) of this title .
“at-risk beneficiary for prescription drug abuse” applies in that section
the term “at-risk beneficiary for prescription drug abuse” means a part D eligible individual who is not an exempted individual described in clause (ii) and— (I) who is identified as such an at-risk beneficiary through the use of clinical guidelines that indicate misuse or abuse of prescription drugs described in subparagraph (G) and that are developed by the Secretary in consultation with PDP sponsors and other stakeholders, including individuals entitled to benefits under part A or enrolled under part B, advocacy groups representing such individuals, physicians, pharmacists, and other clinicians, retail pharmacies, plan sponsors, entities delegated by plan sponsors, and biopharmaceutical …
“frequently abused drug” applies in that section
the term “frequently abused drug” means a drug that is a controlled substance that the Secretary determines to be frequently abused or diverted. (H) Data disclosure (i) Data on decision to impose limitation In the case of an at-risk beneficiary for prescription drug abuse (or an individual who is a potentially at-risk beneficiary for prescription drug abuse) whose access to coverage for frequently abused drugs under a prescription drug plan has been limited by a PDP sponsor under this paragraph, the Secretary shall establish rules and procedures to require the PDP sponsor to disclose data, including any necessary individually identifiable health information, in a form and manner specified …
“eligible fallback entity” applies in that section
the term “eligible fallback entity” means, with respect to all fallback service areas in a PDP region for a contract period, an entity that— (A) meets the requirements to be a PDP sponsor (or would meet such requirements but for the fact that the entity is not a risk-bearing entity); and (B) does not submit a bid under subsection (b) for any prescription drug plan for any PDP region for the first year of such contract period. For purposes of subparagraph (B), an entity shall be treated as submitting a bid with respect to a prescription drug plan if the entity is acting as a subcontractor of a PDP sponsor that is offering such a plan.
“fallback prescription drug plan” applies throughout its part
the term “fallback prescription drug plan” means a prescription drug plan that— (A) only offers the standard prescription drug coverage and access to negotiated prices described in section 1395w–102(a)(1)(A) of this title and does not include any supplemental prescription drug coverage; and (B) meets such other requirements as the Secretary may specify.
“fallback service area” applies in that section
the term “fallback service area” means, for a PDP region with respect to a year, any area within such region for which the Secretary determines before the beginning of the year that the access requirements of the first sentence of section 1395w–103(a) of this title will not be met for part D eligible individuals residing in the area for the year. (4) Fallback prescription drug plan For purposes of this part,
“full risk plan” applies in that section
The term “full risk plan” means a prescription drug plan that is not a limited risk plan or a fallback prescription drug plan. (g) Guaranteeing access to coverage (1) Solicitation of bids (A) In general Separate from the bidding process under subsection (b), the Secretary shall provide for a process for the solicitation of bids from eligible fallback entities (as defined in paragraph (2)) for the offering in all fallback service areas (as defined in paragraph (3)) in one or more PDP regions of a fallback prescription drug plan (as defined in paragraph (4)) during the contract period specified in paragraph (5).
“limited risk plan” applies in that section
The term “limited risk plan” means a prescription drug plan that provides basic prescription drug coverage and for which the PDP sponsor includes a modification of risk level described in subparagraph (E) of subsection (b)(2) in its bid submitted for the plan under such subsection. Such term does not include a fallback prescription drug plan. (B) Full risk plan
“affiliate” applies in that section
The term “affiliate” means, with respect to any pharmacy benefit manager or PDP sponsor, any entity that, directly or indirectly— (i) owns or is owned by, controls or is controlled by, or is otherwise related in any ownership structure to such pharmacy benefit manager or PDP sponsor; or (ii) acts as a contractor, principal, or agent to such pharmacy benefit manager or PDP sponsor, insofar as such contractor, principal, or agent performs any of the functions described under subparagraph (C). (B) Bona fide service fee
“applicable number of calendar days” applies in that section
the term “applicable number of calendar days” means— (i) with respect to claims submitted electronically, 14 days; and (ii) with respect to claims submitted otherwise, 30 days. (C) Interest payment (i) In general Subject to clause (ii), if payment is not issued, mailed, or otherwise transmitted within the applicable number of calendar days (as defined in subparagraph (B)) after a clean claim is received, the PDP sponsor shall pay interest to the pharmacy that submitted the claim at a rate equal to the weighted average of interest on 3-month marketable Treasury securities determined for such period, increased by 0.1 percentage point for the period beginning on the day after the required …
“bona fide service fee” applies in that section
The term “bona fide service fee” means a fee that is reflective of the fair market value (as specified by the Secretary, through notice and comment rulemaking) for a bona fide, itemized service actually performed on behalf of an entity, that the entity would otherwise perform (or contract for) in the absence of the service arrangement and that is not passed on in whole or in part to a client or customer, whether or not the entity takes title to the drug.
“clean claim” applies in that section
the term “clean claim” means a claim that has no defect or impropriety (including any lack of any required substantiating documentation) or particular circumstance requiring special treatment that prevents timely payment from being made on the claim under this part. (iii) Date of receipt of claim In this paragraph, a claim is considered to have been received— (I) with respect to claims submitted electronically, on the date on which the claim is transferred; and (II) with respect to claims submitted otherwise, on the 5th day after the postmark date of the claim or the date specified in the time stamp of the transmission. (B) Applicable number of calendar days defined In this paragraph,
“other prescription drugs” applies in that section
the term “other prescription drugs” means prescription drugs covered as supplemental benefits under this part or prescription drugs paid outside of this part. (D) Audit rights (i) In general Not less than once a year, at the request of the PDP sponsor, the pharmacy benefit manager shall allow for an audit of the pharmacy benefit manager to ensure compliance with all terms and conditions under the written agreement described in this paragraph and the accuracy of information reported under subparagraph (C). (ii) Auditor The PDP sponsor shall have the right to select an auditor. The pharmacy benefit manager shall not impose any limitations on the selection of such auditor.
“pharmacy benefit manager” applies in that section
The term “pharmacy benefit manager” means any person or entity that, either directly or through an intermediary, acts as a price negotiator or group purchaser on behalf of a PDP sponsor or prescription drug plan, or manages the prescription drug benefits provided by such sponsor or plan, including the processing and payment of claims for prescription drugs, the performance of drug utilization review, the processing of drug prior authorization requests, the adjudication of appeals or grievances related to the prescription drug benefit, contracting with network pharmacies, controlling the cost of covered part D drugs, or the provision of related services.
“adjusted national average monthly bid amount” applies in that section
the term “adjusted national average monthly bid amount” means the national average monthly bid amount computed under paragraph (4), as adjusted under section 1395w–115(c)(2) of this title . (C) Increase for supplemental prescription drug benefits The base beneficiary premium shall be increased by the portion of the PDP approved bid that is attributable to supplemental prescription drug benefits. (D) Increase for late enrollment penalty The base beneficiary premium shall be increased by the amount of any late enrollment penalty under subsection (b).
“continuous period of eligibility” applies in that section
the term “continuous period of eligibility” means, with respect to a part D eligible individual, the period that begins with the first day on which the individual is eligible to enroll in a prescription drug plan under this part and ends with the individual’s death.
“creditable prescription drug coverage” applies throughout its part
the term “creditable prescription drug coverage” means any of the following coverage, but only if the coverage meets the requirement of paragraph (5): (A) Coverage under prescription drug plan or MA–PD plan Coverage under a prescription drug plan or under an MA–PD plan. (B) Medicaid Coverage under a medicaid plan under subchapter XIX or under a waiver under section 1315 of this title . (C) Group health plan Coverage under a group health plan, including a health benefits plan under chapter 89 of title 5 (commonly known as the Federal employees health benefits program), and a qualified retiree prescription drug plan (as defined in section 1395w–132(a)(2) of this title ).
“modified adjusted gross income” applies in that section
the term “modified adjusted gross income” has the meaning given such term in subparagraph (A) of section 1395r(i)(4) of this title , determined for the taxable year applicable under subparagraphs (B) and (C) of such section. (D) Determination by Commissioner of Social Security The Commissioner of Social Security shall make any determination necessary to carry out the income-related increase in the base beneficiary premium under this paragraph.
“PDP approved bid” applies throughout its part
the term “PDP approved bid” means, with respect to a prescription drug plan, the bid amount approved for the plan under this part. (7) Increase in base beneficiary premium based on income (A) In general In the case of an individual whose modified adjusted gross income exceeds the threshold amount applicable under paragraph (2) of section 1395r(i) of this title (including application of paragraph (5) of such section) for the calendar year, the monthly amount of the beneficiary premium applicable under this section for a month after December 2010 shall be increased by the monthly adjustment amount specified in subparagraph (B).
“standardized bid amount” applies in that section
the term “standardized bid amount” means the following: (A) Prescription drug plans (i) Basic coverage In the case of a prescription drug plan that provides basic prescription drug coverage, the PDP approved bid (as defined in paragraph (6)). (ii) Supplemental coverage In the case of a prescription drug plan that provides supplemental prescription drug coverage, the portion of the PDP approved bid that is attributable to basic prescription drug coverage. (B) MA–PD plans In the case of an MA–PD plan, the portion of the accepted bid amount that is attributable to basic prescription drug coverage. (6) PDP approved bid defined For purposes of this part,
“uncovered month” applies in that section
the term “uncovered month” means, with respect to a part D eligible individual, any month beginning after the end of the initial enrollment period under section 1395w–101(b)(2) of this title unless the individual can demonstrate that the individual had creditable prescription drug coverage (as defined in paragraph (4)) for any portion of such month. (4) Creditable prescription drug coverage defined For purposes of this part,
“LI NET eligible individual” applies in that section
the term “LI NET eligible individual” means a part D eligible individual who— (A) meets the requirements of clauses (ii) and (iii) of subsection (a)(3)(A); and (B) has not yet enrolled in a prescription drug plan or an MA–PD plan, or, who has so enrolled, but with respect to whom coverage under such plan has not yet taken effect. (3) Transitional coverage For purposes of this subsection,
“low-income benchmark premium amount” applies in that section
the term “low-income benchmark premium amount” means, with respect to a PDP region in which— (i) all prescription drug plans are offered by the same PDP sponsor, the weighted average of the amounts described in subparagraph (B)(i) for such plans; or (ii) there are prescription drug plans offered by more than one PDP sponsor, the weighted average of amounts described in subparagraph (B) for prescription drug plans and MA–PD plans described in section 1395w–21(a)(2)(A)(i) of this title offered in such region.
“poverty line” applies throughout its part
the term “poverty line” has the meaning given such term in section 9902(2) of this title , including any revision required by such section. Nothing in clause (i) shall be construed to affect the application of section 1396a(r)(2) of this title for the determination of eligibility for medical assistance under subchapter XIX.
“subsidy eligible individual” applies throughout its part
the term “subsidy eligible individual” means a part D eligible individual who— (i) is enrolled in a prescription drug plan or MA–PD plan; (ii) has income below 150 percent of the poverty line applicable to a family of the size involved; and (iii) meets the resources requirement described in subparagraph (D) or (E). (B) Determinations (i) In general The determination of whether a part D eligible individual residing in a State is a subsidy eligible individual and whether the individual is described in paragraph (1) shall be determined under the State plan under subchapter XIX for the State under section 1396u–5(a) of this title or by the Commissioner of Social Security.
“transitional coverage” applies in that section
the term “transitional coverage” means with respect to an LI NET eligible individual— (A) immediate access to covered part D drugs at the point of sale during the period that begins on the first day of the month such individual is determined to meet the requirements of clauses (ii) and (iii) of subsection (a)(3)(A) and ends on the date that coverage under a prescription drug plan or MA–PD plan takes effect with respect to such individual; and (B) in the case of an LI NET eligible individual who is a full-benefit dual eligible individual (as defined in section 1396u–5(c)(6) of this title ) or a recipient of supplemental security income benefits under subchapter XVI, retroactive coverage (in …
“applicable beneficiary” applies in that section
The term “applicable beneficiary” means an individual who, on the date of dispensing a covered part D drug— (A) is enrolled in a prescription drug plan or an MA–PD plan; (B) is not enrolled in a qualified retiree prescription drug plan; (C) is not entitled to an income-related subsidy under section 1395w–114(a) of this title ; and (D) who— (i) has reached or exceeded the initial coverage limit under section 1395w–102(b)(3) of this title during the year; and (ii) has not incurred costs for covered part D drugs in the year equal to the annual out-of-pocket threshold specified in section 1395w–102(b)(4)(B) of this title . (2) Applicable drug
“applicable drug” applies in that section
The term “applicable drug” means, with respect to an applicable beneficiary, a covered part D drug— (A) approved under a new drug application under section 355(b) of title 21 or, in the case of a biologic product, licensed under section 262 of this title (other than, with respect to a plan year before 2019, a product licensed under subsection (k) of such section 262); and (B) (i) if the PDP sponsor of the prescription drug plan or the MA organization offering the MA–PD plan uses a formulary, which is on the formulary of the prescription drug plan or MA–PD plan that the applicable beneficiary is enrolled in; (ii) if the PDP sponsor of the prescription drug plan or the MA organization …
“applicable number of calendar days” applies in that section
The term “applicable number of calendar days” means— (A) with respect to claims for reimbursement submitted electronically, 14 days; and (B) with respect to claims for reimbursement submitted otherwise, 30 days. (4) Discounted price (A) In general
“discounted price” applies in that section
The term “discounted price” means 50 percent (or, with respect to a plan year after plan year 2018, 30 percent) of the negotiated price of the applicable drug of a manufacturer. (B) Clarification Nothing in this section shall be construed as affecting the responsibility of an applicable beneficiary for payment of a dispensing fee for an applicable drug.
“manufacturer” applies in that section
The term “manufacturer” means any entity which is engaged in the production, preparation, propagation, compounding, conversion, or processing of prescription drug products, either directly or indirectly by extraction from substances of natural origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis. Such term does not include a wholesale distributor of drugs or a retail pharmacy licensed under State law. (6) Negotiated price
“negotiated price” applies in that section
The term “negotiated price” has the meaning given such term in section 423.100 of title 42, Code of Federal Regulations (as in effect on March 23, 2010 ), except that such negotiated price shall not include any dispensing fee for the applicable drug. (7) Qualified retiree prescription drug plan
“qualified retiree prescription drug plan” applies in that section
The term “qualified retiree prescription drug plan” has the meaning given such term in section 1395w–132(a)(2) of this title . (h) Sunset of program (1) In general The program shall not apply with respect to applicable drugs dispensed on or after January 1, 2025 , and, subject to paragraph (2), agreements under this section shall be terminated as of such date. (2) Continued application for applicable drugs dispensed prior to sunset The provisions of this section (including all responsibilities and duties) shall continue to apply on and after January 1, 2025 , with respect to applicable drugs dispensed prior to such date.
“applicable period” applies in that section
The term “applicable period” means a 12-month period beginning with October 1 of a year (beginning with October 1, 2022 ). (h) Implementation for 2022, 2023, and 2024 The Secretary shall implement this section for 2022, 2023, and 2024 by program instruction or other forms of program guidance.
“applicable period CPI–U” applies in that section
The term “applicable period CPI–U” means, with respect to an applicable period, the consumer price index for all urban consumers (United States city average) for the first month of such applicable period. (6) Average manufacturer price
“average manufacturer price” applies in that section
The term “average manufacturer price” has the meaning, with respect to a part D rebatable drug of a manufacturer, given such term in section 1396r–8(k)(1) of this title , with respect to a covered outpatient drug of a manufacturer for a rebate period under section 1396r–8 of this title . (7) Applicable period
“benchmark period CPI–U” applies in that section
The term “benchmark period CPI–U” means the consumer price index for all urban consumers (United States city average) for January 2021. (5) Applicable period CPI–U
“line extension” applies in that section
the term “line extension” means, with respect to a part D rebatable drug, a new formulation of the drug, such as an extended release formulation, but does not include an abuse-deterrent formulation of the drug (as determined by the Secretary), regardless of whether such abuse-deterrent formulation is an extended release formulation.
“part D rebatable drug” applies in that section
the term “part D rebatable drug” means, with respect to an applicable period, a drug or biological described in subparagraph (C) that is a covered part D drug (as such term is defined under section 1395w–102(e) of this title ). (B) Exclusion (i) In general Such term shall, with respect to an applicable period, not include a drug or biological if the average annual total cost under this part for such period per individual who uses such a drug or biological, as determined by the Secretary, is less than, subject to clause (ii), $100, as determined by the Secretary using the most recent data available or, if data is not available, as estimated by the Secretary.
“payment amount benchmark period” applies in that section
The term “payment amount benchmark period” means the period beginning January 1, 2021 , and ending in the month immediately prior to October 1, 2021 . (4) Benchmark period CPI–U
“unit” applies in that section
The term “unit” means, with respect to a part D rebatable drug, the lowest dispensable amount (such as a capsule or tablet, milligram of molecules, or grams) of the part D rebatable drug, as reported under section 1396r–8 of this title . (3) Payment amount benchmark period
“applicable beneficiary” applies in that section
The term “applicable beneficiary” means an individual who, on the date of dispensing a covered part D drug— (A) is enrolled in a prescription drug plan or an MA–PD plan; (B) is not enrolled in a qualified retiree prescription drug plan; and (C) has incurred costs, as determined in accordance with section 1395w–102(b)(4)(C) of this title , for covered part D drugs in the year that exceed the annual deductible specified in section 1395w–102(b)(1) of this title .
“applicable number of calendar days” applies in that section
The term “applicable number of calendar days” means— (A) with respect to claims for reimbursement submitted electronically, 14 days; and (B) with respect to claims for reimbursement submitted otherwise, 30 days. (4) Discounted price (A) In general
“discounted price” applies in that section
The term “discounted price” means, subject to subparagraphs (B) and (C), with respect to an applicable drug of a manufacturer dispensed during a year to an applicable beneficiary— (i) who has not incurred costs, as determined in accordance with section 1395w–102(b)(4)(C) of this title , for covered part D drugs in the year that are equal to or exceed the annual out-of-pocket threshold specified in section 1395w–102(b)(4)(B)(i) of this title for the year, 90 percent of the negotiated price of such drug; and (ii) who has incurred such costs, as so determined, in the year that are equal to or exceed such threshold for the year, 80 percent of the negotiated price of such drug.
“manufacturer” applies in that section
The term “manufacturer” means any entity which is engaged in the production, preparation, propagation, compounding, conversion, or processing of prescription drug products, either directly or indirectly by extraction from substances of natural origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis. Such term does not include a wholesale distributor of drugs or a retail pharmacy licensed under State law. (6) Negotiated price
“negotiated price” applies in that section
The term “negotiated price” has the meaning given such term for purposes of section 1395w–102(d)(1)(B) of this title , and, with respect to an applicable drug, such negotiated price shall include any dispensing fee and, if applicable, any vaccine administration fee for the applicable drug. (7) Qualified retiree prescription drug plan
“qualified retiree prescription drug plan” applies in that section
The term “qualified retiree prescription drug plan” has the meaning given such term in section 1395w–132(a)(2) of this title .
“specified drug” applies in that section
the term “specified drug” means, with respect to a specified manufacturer, for 2021, an applicable drug that is produced, prepared, propagated, compounded, converted, or processed by the manufacturer. (bb) Aggregation rule All persons treated as a single employer under subsection (a) or (b) of section 52 of the Internal Revenue Code of 1986 shall be treated as one manufacturer for purposes of this subparagraph. For purposes of making a determination pursuant to the previous sentence, an agreement under this section shall require that a manufacturer provide and attest to such information as specified by the Secretary as necessary.
“specified manufacturer” applies in that section
the term “specified manufacturer” means a manufacturer of an applicable drug for which, in 2021— (aa) the manufacturer had a coverage gap discount agreement under section 1395w–114a of this title ; (bb) the total expenditures for all of the specified drugs of the manufacturer covered by such agreement or agreements for such year and covered under this part during such year represented less than 1.0 percent of the total expenditures under this part for all covered Part 1 D drugs during such year; and (cc) the total expenditures for all of the specified drugs of the manufacturer that are single source drugs and biological products for which payment may be made under part B during such year …
“specified small manufacturer” applies in that section
the term “specified small manufacturer” means a manufacturer of an applicable drug for which, in 2021— (aa) the manufacturer is a specified manufacturer (as defined in subparagraph (B)(ii)); and (bb) the total expenditures under part D for any one of the specified small manufacturer drugs of the manufacturer that are covered by the agreement or agreements under section 1395w–114a of this title of such manufacturer for such year and covered under this part during such year are equal to or more than 80 percent of the total expenditures under this part for all specified small manufacturer drugs of the manufacturer that are covered by such agreement or agreements for such year and covered under …
“specified small manufacturer drugs” applies in that section
the term “specified small manufacturer drugs” means, with respect to a specified small manufacturer, for 2021, an applicable drug that is produced, prepared, propagated, compounded, converted, or processed by the manufacturer. (bb) Aggregation rule All persons treated as a single employer under subsection (a) or (b) of section 52 of the Internal Revenue Code of 1986 shall be treated as one manufacturer for purposes of this subparagraph. For purposes of making a determination pursuant to the previous sentence, an agreement under this section shall require that a manufacturer provide and attest to such information as specified by the Secretary as necessary.
“specified small manufacturer percent” applies in that section
the term “specified small manufacturer percent” means, with respect to a year— (I) for an applicable drug dispensed for an applicable beneficiary who has not incurred costs, as determined in accordance with section 1395w–102(b)(4)(C) of this title , for covered part D drugs in the year that are equal to or exceed the annual out-of-pocket threshold specified in section 1395w–102(b)(4)(B)(i) of this title for the year— (aa) for 2025, 99 percent; (bb) for 2026, 98 percent; (cc) for 2027, 95 percent; (dd) for 2028, 92 percent; and (ee) for 2029 and each subsequent year, 90 percent; and (II) for an applicable drug dispensed for an applicable beneficiary who has incurred costs, as determined in …
“total expenditures” applies in that section
the term “total expenditures” includes, in the case of expenditures with respect to part D, the total gross covered prescription drug costs as defined in section 1395w–115(b)(3) of this title . The term “total expenditures” excludes, in the case of expenditures with respect to part B, expenditures for a drug or biological that are bundled or packaged into the payment for another service.
“adjusted allowable risk corridor costs” applies in that section
the term “adjusted allowable risk corridor costs” means, for a plan for a coverage year (as defined in subsection (b)(4))— (i) the allowable risk corridor costs (as defined in subparagraph (B)) for the plan for the year, reduced by (ii) the sum of (I) the total reinsurance payments made under subsection (b) to the sponsor of the plan for the year, and (II) the total subsidy payments made under section 1395w–114 of this title to the sponsor of the plan for the year. (B) Allowable risk corridor costs For purposes of this subsection,
“allowable reinsurance costs” applies in that section
the term “allowable reinsurance costs” means, with respect to gross covered prescription drug costs under a prescription drug plan offered by a PDP sponsor or an MA–PD plan offered by an MA organization, the part of such costs that are actually paid (net of discounts, chargebacks, and average percentage rebates) by the sponsor or organization or by (or on behalf of) an enrollee under the plan, but in no case more than the part of such costs that would have been paid under the plan if the prescription drug coverage under the plan were basic prescription drug coverage, or, in the case of a plan providing supplemental prescription drug coverage, if such coverage were standard prescription drug …
“allowable risk corridor costs” applies in that section
the term “allowable risk corridor costs” means, with respect to a prescription drug plan offered by a PDP sponsor or an MA–PD plan offered by an MA organization, the part of costs (not including administrative costs, but including costs directly related to the dispensing of covered part D drugs during the year) incurred by the sponsor or organization under the plan that are actually paid (net of discounts, chargebacks, and average percentage rebates) by the sponsor or organization under the plan, but in no case more than the part of such costs that would have been paid under the plan if the prescription drug coverage under the plan were basic prescription drug coverage, or, in the case of a …
“coverage year” applies in that section
the term “coverage year” means a calendar year in which covered part D drugs are dispensed if the claim for such drugs (and payment on such claim) is made not later than such period after the end of such year as the Secretary specifies. (c) Adjustments relating to bids (1) Health status risk adjustment (A) Establishment of risk adjustors The Secretary shall establish an appropriate methodology for adjusting the standardized bid amount under subsection (a)(1)(A) to take into account variation in costs for basic prescription drug coverage among prescription drug plans and MA–PD plans based on the differences in actuarial risk of different enrollees being served.
“gross covered prescription drug costs” applies in that section
the term “gross covered prescription drug costs” means, with respect to a part D eligible individual enrolled in a prescription drug plan or MA–PD plan during a coverage year, the costs incurred under the plan, not including administrative costs, but including costs directly related to the dispensing of covered part D drugs during the year and costs relating to the deductible.
“required coverage” applies in that section
the term “required coverage” means with respect to an MA–PD plan— (A) basic prescription drug coverage; or (B) qualified prescription drug coverage that provides supplemental prescription drug coverage, so long as there is no MA monthly supplemental beneficiary premium applied under the plan (due to the application of a credit against such premium of a rebate under section 1395w–24(b)(1)(C) of this title ).
“allowable retiree costs” applies in that section
The term “allowable retiree costs” means, with respect to gross covered prescription drug costs under a qualified retiree prescription drug plan by a plan sponsor, the part of such costs that are actually paid (net of discounts, chargebacks, and average percentage rebates) by the sponsor or by or on behalf of a qualifying covered retiree under the plan. (ii) Gross covered retiree plan-related prescription drug costs For purposes of this section,
“coverage year” applies in that section
The term “coverage year” has the meaning given such term in section 1395w–115(b)(4) of this title . (4) Qualifying covered retiree defined For purposes of this subsection,
“employment-based retiree health coverage” applies in that section
The term “employment-based retiree health coverage” means health insurance or other coverage of health care costs (whether provided by voluntary insurance coverage or pursuant to statutory or contractual obligation) for part D eligible individuals (or for such individuals and their spouses and dependents) under a group health plan based on their status as retired participants in such plan. (2) Sponsor
“gross covered retiree plan-related prescription drug costs” applies in that section
the term “gross covered retiree plan-related prescription drug costs” means, with respect to a qualifying covered retiree enrolled in a qualified retiree prescription drug plan during a coverage year, the costs incurred under the plan, not including administrative costs, but including costs directly related to the dispensing of covered part D drugs during the year. Such costs shall be determined whether they are paid by the retiree or under the plan. (iii) Coverage year
“group health plan” applies in that section
The term “group health plan” includes such a plan as defined in section 1167(1) of title 29 and also includes the following: (A) Federal and State governmental plans Such a plan established or maintained for its employees by the Government of the United States, by the government of any State or political subdivision thereof, or by any agency or instrumentality of any of the foregoing, including a health benefits plan offered under chapter 89 of title 5. (B) Collectively bargained plans Such a plan established or maintained under or pursuant to one or more collective bargaining agreements.
“qualified retiree prescription drug plan” applies in that section
the term “qualified retiree prescription drug plan” means employment-based retiree health coverage (as defined in subsection (c)(1)) if, with respect to a part D eligible individual who is a participant or beneficiary under such coverage, the following requirements are met: (A) Attestation of actuarial equivalence to standard coverage The sponsor of the plan provides the Secretary, annually or at such other time as the Secretary may require, with an attestation that the actuarial value of prescription drug coverage under the plan (as determined using the processes and methods described in section 1395w–111(c) of this title ) is at least equal to the actuarial value of standard prescription …
“qualifying covered retiree” applies in that section
the term “qualifying covered retiree” means a part D eligible individual who is not enrolled in a prescription drug plan or an MA–PD plan but is covered under a qualified retiree prescription drug plan. (5) Payment methods, including provision of necessary information The provisions of section 1395w–115(d) of this title (including paragraph (2), relating to requirement for provision of information) shall apply to payments under this subsection in a manner similar to the manner in which they apply to payment under section 1395w–115(b) of this title .
“sponsor” applies in that section
The term “sponsor” means a plan sponsor, as defined in section 1002(16)(B) of title 29 , in relation to a group health plan, except that, in the case of a plan maintained jointly by one employer and an employee organization and with respect to which the employer is the primary source of financing, such term means such employer. (3) Group health plan
“part D plan” applies in that section
the term “part D plan” means a prescription drug plan and an MA–PD plan. (b) State Pharmaceutical Assistance Program For purposes of this part,
“State Pharmaceutical Assistance Program” applies throughout its part
the term “State Pharmaceutical Assistance Program” means a State program— (1) which provides financial assistance for the purchase or provision of supplemental prescription drug coverage or benefits on behalf of part D eligible individuals; (2) which, in determining eligibility and the amount of assistance to part D eligible individuals under the Program, provides assistance to such individuals in all part D plans and does not discriminate based upon the part D plan in which the individual is enrolled; and (3) which satisfies the requirements of subsections (a) and (c).
“covered discount card drug” applies in that 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 . (B) Discount card eligible individual The term “discount card eligible individual” is defined in subsection (b)(1)(A). (C) Endorsed discount card program; endorsed program
“discount card eligible individual” applies in that section
The term “discount card eligible individual” means an individual who— (i) is entitled to benefits, or enrolled, under part A or enrolled under part B; and (ii) subject to paragraph (4), is not an individual described in subparagraph (B). (B) Individual described 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 .
“endorsed discount card program” applies in that section
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. (D) Negotiated price Negotiated prices are described in subsection (e)(1)(A)(ii). (E) Prescription drug card sponsor; sponsor The terms “prescription drug card sponsor” and “sponsor” are defined in subsection (h)(1)(A). (F) State
“endorsed program” applies in that section
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. (D) Negotiated price Negotiated prices are described in subsection (e)(1)(A)(ii). (E) Prescription drug card sponsor; sponsor The terms “prescription drug card sponsor” and “sponsor” are defined in subsection (h)(1)(A). (F) State
“prescription drug card sponsor” applies in that 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— (i) a pharmaceutical benefit management company; (ii) a wholesale or retail pharmacy delivery system; (iii) an insurer (including an insurer that offers medicare supplemental policies under section 1395ss of this title ); (iv) an organization offering a plan under part C; or (v) any combination of the entities described in clauses (i) through (iv).
“special transitional assistance eligible individual” applies in that section
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)).
“sponsor” applies in that 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— (i) a pharmaceutical benefit management company; (ii) a wholesale or retail pharmacy delivery system; (iii) an insurer (including an insurer that offers medicare supplemental policies under section 1395ss of this title ); (iv) an organization offering a plan under part C; or (v) any combination of the entities described in clauses (i) through (iv).
“State” applies in that section
The term “State” has the meaning given such term for purposes of subchapter XIX. (G) Transitional assistance eligible individual The term “transitional assistance eligible individual” is defined in subsection (b)(2). (b) Eligibility for discount card and for transitional assistance For purposes of this section: (1) Discount card eligible individual (A) In general
“transitional assistance eligible individual” applies in that section
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)).
“creditable prescription drug coverage” applies throughout its part
The term “creditable prescription drug coverage” has the meaning given such term in section 1395w–113(b)(4) of this title . (4) Part D eligible individual
“fallback prescription drug plan” applies throughout its part
The term “fallback prescription drug plan” has the meaning given such term in section 1395w–111(g)(4) of this title . (6) Initial coverage limit
“initial coverage limit” applies throughout its part
The term “initial coverage limit” means such limit as established under section 1395w–102(b)(3) of this title for a year before 2025, or, in the case of coverage that is not standard prescription drug coverage, the comparable limit (if any) established under the coverage for such year. (7) Insurance risk
“insurance risk” applies throughout its part
The term “insurance risk” means, with respect to a participating pharmacy, risk of the type commonly assumed only by insurers licensed by a State and does not include payment variations designed to reflect performance-based measures of activities within the control of the pharmacy, such as formulary compliance and generic drug substitution. (8) MA plan
“MA plan” applies throughout its part
The term “MA plan” has the meaning given such term in section 1395w–101(a)(3)(B) of this title . 1 (9) MA–PD plan
“MA–PD plan” applies throughout its part
The term “MA–PD plan” has the meaning given such term in section 1395w–101(a)(3)(C) of this title . 1 (10) Medicare Prescription Drug Account
“Medicare Prescription Drug Account” applies throughout its part
The term “Medicare Prescription Drug Account” means the Account created under section 1395w–116(a) of this title . (11) PDP approved bid
“part D eligible individual” applies throughout its part
The term “part D eligible individual” has the meaning given such term in section 1395w–101(a)(3)(A) of this title . 1 (5) Fallback prescription drug plan
“PDP approved bid” applies throughout its part
The term “PDP approved bid” has the meaning given such term in section 1395w–113(a)(6) of this title . (12) PDP region
“PDP region” applies throughout its part
The term “PDP region” means such a region as provided under section 1395w–111(a)(2) of this title . (13) PDP sponsor
“PDP sponsor” applies throughout its part
The term “PDP sponsor” means a nongovernmental entity that is certified under this part as meeting the requirements and standards of this part for such a sponsor. (14) Prescription drug plan
“prescription drug plan” applies throughout its part
The term “prescription drug plan” means prescription drug coverage that is offered— (A) under a policy, contract, or plan that has been approved under section 1395w–111(e) of this title ; and (B) by a PDP sponsor pursuant to, and in accordance with, a contract between the Secretary and the sponsor under section 1395w–112(b) of this title . (15) Qualified prescription drug coverage The term “qualified prescription drug coverage” is defined in section 1395w–102(a)(1) of this title . (16) Standard prescription drug coverage The term “standard prescription drug coverage” is defined in section 1395w–102(b) of this title . (17) State Pharmaceutical Assistance Program
“State Pharmaceutical Assistance Program” applies throughout its part
The term “State Pharmaceutical Assistance Program” has the meaning given such term in section 1395w–133(b) of this title . (18) Subsidy eligible individual
“subsidy eligible individual” applies throughout its part
The term “subsidy eligible individual” has the meaning given such term in section 1395w–114(a)(3)(A) of this title . (b) Application of part C provisions under this part For purposes of applying provisions of part C under this part with respect to a prescription drug plan and a PDP sponsor, unless otherwise provided in this part such provisions shall be applied as if— (1) any reference to an MA plan included a reference to a prescription drug plan; (2) any reference to an MA organization or a provider-sponsored organization included a reference to a PDP sponsor; (3) any reference to a contract under section 1395w–27 of this title included a reference to a contract under section 1395w–112(b) …
“affiliate” applies in that section
the terms “affiliate” and “pharmacy benefit manager” have the meaning given those terms in section 1395w–112(h)(7) of this title . (f) Biennial report on enforcement and oversight of pharmacy access requirements (1) In general Not later than 2 years after February 3, 2026 , and at least once every 2 years thereafter, the Secretary shall publish a report on enforcement and oversight actions and activities undertaken by the Secretary with respect to the requirements under section 1395w–104(b)(1) of this title .
“essential retail pharmacy” applies in that section
the term “essential retail pharmacy” means, with respect to a plan year, a retail pharmacy that— (A) is not a pharmacy that is an affiliate as defined in paragraph (4); and (B) is located in— (i) a rural area in which there is no other retail pharmacy within 10 miles, as determined by the Secretary; (ii) a suburban area in which there is no other retail pharmacy within 2 miles, as determined by the Secretary; or (iii) an urban area in which there is no other retail pharmacy within 1 mile, as determined by the Secretary.
“pharmacy benefit manager” applies in that section
the terms “affiliate” and “pharmacy benefit manager” have the meaning given those terms in section 1395w–112(h)(7) of this title . (f) Biennial report on enforcement and oversight of pharmacy access requirements (1) In general Not later than 2 years after February 3, 2026 , and at least once every 2 years thereafter, the Secretary shall publish a report on enforcement and oversight actions and activities undertaken by the Secretary with respect to the requirements under section 1395w–104(b)(1) of this title .
“manufacturer” applies in that section
the term “manufacturer” has the meaning given such term in section 1395w–114a(g)(5) of this title .
“MA–PD plan” applies in that section
The term “MA–PD plan” has the meaning given such term in section 1395w–151(a)(9) of this title . (2) Prescription drug plan