42 USC § 1395w–102 - Prescription drug benefits
(a)
Requirements
(1)
In general
For purposes of this part and part C of this subchapter, 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) of this section) and access to negotiated prices under subsection (d) of this section.
(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) of this section and access to negotiated prices under subsection (d) of this section, but only if the benefit design of such coverage is approved by the Secretary, as provided under subsection (c) of this section.
(2)
Permitting supplemental prescription drug coverage
(A)
In general
Subject to subparagraph (B), qualified prescription drug coverage may include supplemental prescription drug coverage consisting of either or both of the following:
(i)
Certain reductions in cost-sharing
(I)
In general
A reduction in the annual deductible, a reduction in the coinsurance percentage, or an increase in the initial coverage limit with respect to covered part D drugs, or any combination thereof, insofar as such a reduction or increase increases the actuarial value of benefits above the actuarial value of basic prescription drug coverage.
(3)
Basic prescription drug coverage
For purposes of this part and part C of this subchapter, the term “basic prescription drug coverage” means either of the following:
(b)
Standard prescription drug coverage
For purposes of this part and part C of this subchapter, the term “standard prescription drug coverage” means coverage of covered part D drugs that meets the following requirements:
(2)
Benefit structure
(A)
25 percent coinsurance
Subject to subparagraphs (C) and (D), the coverage has coinsurance (for costs above the annual deductible specified in paragraph (1) and up to the initial coverage limit under paragraph (3)) that is—
(B)
Use of tiers
Nothing in this part shall be construed as preventing a PDP sponsor or an MA organization from applying tiered copayments under a plan, so long as such tiered copayments are consistent with subparagraphs (A)(ii), (C), and (D).
(C)
Coverage for generic drugs in coverage gap
(i)
In general
Except as provided in paragraph (4), the coverage for an applicable beneficiary (as defined in section
1395w–114a
(g)(1) of this title) has coinsurance (for costs above the initial coverage limit under paragraph (3) and below the out-of-pocket threshold) for covered part D drugs that are not applicable drugs under section
1395w–114a
(g)(2) of this title that is—
(II)
actuarially equivalent (using processes and methods established under section
1395w–111
(c) of this title) to an average expected payment of such percentage of such costs for covered part D drugs that are not applicable drugs under section
1395w–114a
(g)(2) of this title.
(D)
Coverage for applicable drugs in coverage gap
(i)
In general
Except as provided in paragraph (4), the coverage for an applicable beneficiary (as defined in section
1395w–114a
(g)(1) of this title) has coinsurance (for costs above the initial coverage limit under paragraph (3) and below the out-of-pocket threshold) for the negotiated price (as defined in section
1395w–114a
(g)(6) of this title) of covered part D drugs that are applicable drugs under section
1395w–114a
(g)(2) of this title that is—
(I)
equal to the difference between the applicable gap percentage (specified in clause (ii) for the year) and the discount percentage specified in section
1395w–114a
(g)(4)(A) of this title for such applicable drugs; or
(II)
actuarially equivalent (using processes and methods established under section
1395w–111
(c) of this title) to an average expected payment of such percentage of such costs, for covered part D drugs that are applicable drugs under section
1395w–114a
(g)(2) of this title.
(3)
Initial coverage limit
(4)
Protection against high out-of-pocket expenditures
(A)
In general
(i)
In general
The coverage provides benefits, after the part D eligible individual has incurred costs (as described in subparagraph (C)) for covered part D drugs in a year equal to the annual out-of-pocket threshold specified in subparagraph (B), with cost-sharing that is equal to the greater of—
(I)
a copayment of $2 for a generic drug or a preferred drug that is a multiple source drug (as defined in section
1396r–8
(k)(7)(A)(i) of this title) and $5 for any other drug; or
(ii)
Adjustment of amount
For a year after 2006, the dollar amounts specified in clause (i)(I) shall be equal to the dollar amounts specified in this subparagraph for the previous year, increased by the annual percentage increase described in paragraph (6) for the year involved. Any amount established under this clause that is not a multiple of a 5 cents shall be rounded to the nearest multiple of 5 cents.
(B)
Annual out-of-pocket threshold
(i)
In general
For purposes of this part, the “annual out-of-pocket threshold” specified in this subparagraph—
(II)
for each of years 2007 through 2013, is equal to the amount specified in this subparagraph for the previous year, increased by the annual percentage increase described in paragraph (6) for the year involved;
(III)
for 2014 and 2015, is equal to the amount specified in this subparagraph for the previous year, increased by the annual percentage increase described in paragraph (6) for the year involved, minus 0.25 percentage point;
(IV)
for each of years 2016 through 2019, is equal to the amount specified in this subparagraph for the previous year, increased by the lesser of—
(C)
Application
Except as provided in subparagraph (E), in applying subparagraph (A)—
(i)
incurred costs shall only include costs incurred with respect to covered part D drugs for the annual deductible described in paragraph (1), for cost-sharing described in paragraph (2), and for amounts for which benefits are not provided because of the application of the initial coverage limit described in paragraph (3), but does not include any costs incurred for covered part D drugs which are not included (or treated as being included) in the plan’s formulary;
(ii)
subject to clause (iii), such costs shall be treated as incurred only if they are paid by the part D eligible individual (or by another person, such as a family member, on behalf of the individual) and the part D eligible individual (or other person) is not reimbursed through insurance or otherwise, a group health plan, or other third-party payment arrangement (other than under such section or such a Program) for such costs; and
(D)
Information regarding third-party reimbursement
(i)
Procedures for exchanging information
In order to accurately apply the requirements of subparagraph (C)(ii), the Secretary is authorized to establish procedures, in coordination with the Secretary of the Treasury and the Secretary of Labor—
(ii)
Authority to request information from enrollees
A PDP sponsor or an MA organization may periodically ask part D eligible individuals enrolled in a prescription drug plan or an MA–PD plan offered by the sponsor or organization whether such individuals have or expect to receive such third-party reimbursement. A material misrepresentation of the information described in the preceding sentence by an individual (as defined in standards set by the Secretary and determined through a process established by the Secretary) shall constitute grounds for termination of enrollment in any plan under section
1395w–21
(g)(3)(B) of this title (and as applied under this part under section
1395w–101
(b)(1)(B)(v) of this title) for a period specified by the Secretary.
(E)
Inclusion of costs of applicable drugs under medicare coverage gap discount program
In applying subparagraph (A), incurred costs shall include the negotiated price (as defined in paragraph (6) of section
1395w–114a
(g) of this title) of an applicable drug (as defined in paragraph (2) of such section) of a manufacturer that is furnished to an applicable beneficiary (as defined in paragraph (1) of such section) under the Medicare coverage gap discount program under section
1395w–114a of this title, regardless of whether part of such costs were paid by a manufacturer under such program, except that incurred costs shall not include the portion of the negotiated price that represents the reduction in coinsurance resulting from the application of paragraph (2)(D).
(5)
Construction
Nothing in this part shall be construed as preventing a PDP sponsor or an MA organization offering an MA–PD plan from reducing to zero the cost-sharing otherwise applicable to preferred or generic drugs.
(6)
Annual percentage increase
The annual percentage increase specified in this paragraph for a year is equal to the annual percentage increase in average per capita aggregate expenditures for covered part D drugs in the United States for part D eligible individuals, as determined by the Secretary for the 12-month period ending in July of the previous year using such methods as the Secretary shall specify.
(c)
Alternative prescription drug coverage requirements
A prescription drug plan or an MA–PD plan may provide a different prescription drug benefit design from standard prescription drug coverage so long as the Secretary determines (consistent with section
1395w–111
(c) of this title) that the following requirements are met and the plan applies for, and receives, the approval of the Secretary for such benefit design:
(1)
Assuring at least actuarially equivalent coverage
(A)
Assuring equivalent value of total coverage
The actuarial value of the total coverage is at least equal to the actuarial value of standard prescription drug coverage.
(B)
Assuring equivalent unsubsidized value of coverage
The unsubsidized value of the coverage is at least equal to the unsubsidized value of standard prescription drug coverage. For purposes of this subparagraph, the unsubsidized value of coverage is the amount by which the actuarial value of the coverage exceeds the actuarial value of the subsidy payments under section
1395w–115 of this title with respect to such coverage.
(C)
Assuring standard payment for costs at initial coverage limit
The coverage is designed, based upon an actuarially representative pattern of utilization, to provide for the payment, with respect to costs incurred that are equal to the initial coverage limit under subsection (b)(3) of this section for the year, of an amount equal to at least the product of—
(d)
Access to negotiated prices
(1)
Access
(A)
In general
Under qualified prescription drug coverage offered by a PDP sponsor offering a prescription drug plan or an MA organization offering an MA–PD plan, the sponsor or organization shall provide enrollees with access to negotiated prices used for payment for covered part D drugs, regardless of the fact that no benefits may be payable under the coverage with respect to such drugs because of the application of a deductible or other cost-sharing or an initial coverage limit (described in subsection (b)(3) of this section).
(B)
Negotiated prices
For purposes of this part, negotiated prices shall take into account negotiated price concessions, such as discounts, direct or indirect subsidies, rebates, and direct or indirect remunerations, for covered part D drugs, and include any dispensing fees for such drugs.
(C)
Medicaid-related provisions
The prices negotiated by a prescription drug plan, by an MA–PD plan with respect to covered part D drugs, or by a qualified retiree prescription drug plan (as defined in section
1395w–132
(a)(2) of this title) with respect to such drugs on behalf of part D eligible individuals, 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.
(2)
Disclosure
A PDP sponsor offering a prescription drug plan or an MA organization offering an MA–PD plan shall disclose to the Secretary (in a manner specified by the Secretary) the aggregate negotiated price concessions described in paragraph (1)(B) made available to the sponsor or organization by a manufacturer which are passed through in the form of lower subsidies, lower monthly beneficiary prescription drug premiums, and lower prices through pharmacies and other dispensers. The provisions of section
1396r–8
(b)(3)(D) of this title apply to information disclosed to the Secretary under this paragraph.
(3)
Audits
To protect against fraud and abuse and to ensure proper disclosures and accounting under this part and in accordance with section
1395w–27
(d)(2)(B) of this title (as applied under section
1395w–112
(b)(3)(C) of this title), the Secretary may conduct periodic audits, directly or through contracts, of the financial statements and records of PDP sponsors with respect to prescription drug plans and MA organizations with respect to MA–PD plans.
(e)
Covered part D drug defined
(1)
In general
Except as provided in this subsection, for purposes of this 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; or
(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),
and such term includes a vaccine licensed under section
262 of this title (and, for vaccines administered on or after January 1, 2008, its administration) and any use of a covered part D drug for a medically accepted indication (as defined in paragraph (4)).
(2)
Exclusions
(A)
In general
Such term does not include drugs or classes of drugs, or their medical uses, which may be excluded from coverage or otherwise restricted under section
1396r–8
(d)(2) of this title, other than subparagraph (E) of such section (relating to smoking cessation agents), other than subparagraph (I) of such section (relating to barbiturates) if the barbiturate is used in the treatment of epilepsy, cancer, or a chronic mental health disorder, and other than subparagraph (J) of such section (relating to benzodiazepines), or under section
1396r–8
(d)(3) of this title, as such sections were in effect on December 8, 2003. Such term also does not include a drug when used for the treatment of sexual or erectile dysfunction, unless such drug were used to treat a condition, other than sexual or erectile dysfunction, for which the drug has been approved by the Food and Drug Administration.
(B)
Medicare covered drugs
A drug prescribed for a part D eligible individual that would otherwise be a covered part D drug under this part shall not be so considered if payment for such drug as so prescribed and dispensed or administered with respect to that individual is available (or would be available but for the application of a deductible) under part A or B of this subchapter for that individual.
(3)
Application of general exclusion provisions
A prescription drug plan or an MA–PD plan may exclude from qualified prescription drug coverage any covered part D drug—
Such exclusions are determinations subject to reconsideration and appeal pursuant to subsections (g) and (h), respectively, of section
1395w–104 of this title.
(4)
Medically accepted indication defined
(A)
In general
For purposes of paragraph (1), 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
(B)
Conflict of interest
On and after January 1, 2010, subparagraph (A)(i)(II) shall not apply unless the compendia described in section
1396r–8
(g)(1)(B)(i)(III) of this title meets
[1]
the requirement in the third sentence of section
1395x
(t)(2)(B) of this title.
(C)
Update
For purposes of applying subparagraph (A)(ii), the Secretary shall revise the list of compendia described in section
1396r–8
(g)(1)(B)(i) of this title as is appropriate for identifying medically accepted indications for drugs. Any such revision shall be done in a manner consistent with the process for revising compendia under section
1395x
(t)(2)(B) of this title.
[1] So in original. Probably should be “meet”.
(a)
Requirements
(1)
In general
For purposes of this part and part C of this subchapter, 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) of this section) and access to negotiated prices under subsection (d) of this section.
(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) of this section and access to negotiated prices under subsection (d) of this section, but only if the benefit design of such coverage is approved by the Secretary, as provided under subsection (c) of this section.
(2)
Permitting supplemental prescription drug coverage
(A)
In general
Subject to subparagraph (B), qualified prescription drug coverage may include supplemental prescription drug coverage consisting of either or both of the following:
(i)
Certain reductions in cost-sharing
(I)
In general
A reduction in the annual deductible, a reduction in the coinsurance percentage, or an increase in the initial coverage limit with respect to covered part D drugs, or any combination thereof, insofar as such a reduction or increase increases the actuarial value of benefits above the actuarial value of basic prescription drug coverage.
(3)
Basic prescription drug coverage
For purposes of this part and part C of this subchapter, the term “basic prescription drug coverage” means either of the following:
(b)
Standard prescription drug coverage
For purposes of this part and part C of this subchapter, the term “standard prescription drug coverage” means coverage of covered part D drugs that meets the following requirements:
(2)
Benefit structure
(A)
25 percent coinsurance
Subject to subparagraphs (C) and (D), the coverage has coinsurance (for costs above the annual deductible specified in paragraph (1) and up to the initial coverage limit under paragraph (3)) that is—
(B)
Use of tiers
Nothing in this part shall be construed as preventing a PDP sponsor or an MA organization from applying tiered copayments under a plan, so long as such tiered copayments are consistent with subparagraphs (A)(ii), (C), and (D).
(C)
Coverage for generic drugs in coverage gap
(i)
In general
Except as provided in paragraph (4), the coverage for an applicable beneficiary (as defined in section
1395w–114a
(g)(1) of this title) has coinsurance (for costs above the initial coverage limit under paragraph (3) and below the out-of-pocket threshold) for covered part D drugs that are not applicable drugs under section
1395w–114a
(g)(2) of this title that is—
(II)
actuarially equivalent (using processes and methods established under section
1395w–111
(c) of this title) to an average expected payment of such percentage of such costs for covered part D drugs that are not applicable drugs under section
1395w–114a
(g)(2) of this title.
(D)
Coverage for applicable drugs in coverage gap
(i)
In general
Except as provided in paragraph (4), the coverage for an applicable beneficiary (as defined in section
1395w–114a
(g)(1) of this title) has coinsurance (for costs above the initial coverage limit under paragraph (3) and below the out-of-pocket threshold) for the negotiated price (as defined in section
1395w–114a
(g)(6) of this title) of covered part D drugs that are applicable drugs under section
1395w–114a
(g)(2) of this title that is—
(I)
equal to the difference between the applicable gap percentage (specified in clause (ii) for the year) and the discount percentage specified in section
1395w–114a
(g)(4)(A) of this title for such applicable drugs; or
(II)
actuarially equivalent (using processes and methods established under section
1395w–111
(c) of this title) to an average expected payment of such percentage of such costs, for covered part D drugs that are applicable drugs under section
1395w–114a
(g)(2) of this title.
(3)
Initial coverage limit
(4)
Protection against high out-of-pocket expenditures
(A)
In general
(i)
In general
The coverage provides benefits, after the part D eligible individual has incurred costs (as described in subparagraph (C)) for covered part D drugs in a year equal to the annual out-of-pocket threshold specified in subparagraph (B), with cost-sharing that is equal to the greater of—
(I)
a copayment of $2 for a generic drug or a preferred drug that is a multiple source drug (as defined in section
1396r–8
(k)(7)(A)(i) of this title) and $5 for any other drug; or
(ii)
Adjustment of amount
For a year after 2006, the dollar amounts specified in clause (i)(I) shall be equal to the dollar amounts specified in this subparagraph for the previous year, increased by the annual percentage increase described in paragraph (6) for the year involved. Any amount established under this clause that is not a multiple of a 5 cents shall be rounded to the nearest multiple of 5 cents.
(B)
Annual out-of-pocket threshold
(i)
In general
For purposes of this part, the “annual out-of-pocket threshold” specified in this subparagraph—
(II)
for each of years 2007 through 2013, is equal to the amount specified in this subparagraph for the previous year, increased by the annual percentage increase described in paragraph (6) for the year involved;
(III)
for 2014 and 2015, is equal to the amount specified in this subparagraph for the previous year, increased by the annual percentage increase described in paragraph (6) for the year involved, minus 0.25 percentage point;
(IV)
for each of years 2016 through 2019, is equal to the amount specified in this subparagraph for the previous year, increased by the lesser of—
(C)
Application
Except as provided in subparagraph (E), in applying subparagraph (A)—
(i)
incurred costs shall only include costs incurred with respect to covered part D drugs for the annual deductible described in paragraph (1), for cost-sharing described in paragraph (2), and for amounts for which benefits are not provided because of the application of the initial coverage limit described in paragraph (3), but does not include any costs incurred for covered part D drugs which are not included (or treated as being included) in the plan’s formulary;
(ii)
subject to clause (iii), such costs shall be treated as incurred only if they are paid by the part D eligible individual (or by another person, such as a family member, on behalf of the individual) and the part D eligible individual (or other person) is not reimbursed through insurance or otherwise, a group health plan, or other third-party payment arrangement (other than under such section or such a Program) for such costs; and
(D)
Information regarding third-party reimbursement
(i)
Procedures for exchanging information
In order to accurately apply the requirements of subparagraph (C)(ii), the Secretary is authorized to establish procedures, in coordination with the Secretary of the Treasury and the Secretary of Labor—
(ii)
Authority to request information from enrollees
A PDP sponsor or an MA organization may periodically ask part D eligible individuals enrolled in a prescription drug plan or an MA–PD plan offered by the sponsor or organization whether such individuals have or expect to receive such third-party reimbursement. A material misrepresentation of the information described in the preceding sentence by an individual (as defined in standards set by the Secretary and determined through a process established by the Secretary) shall constitute grounds for termination of enrollment in any plan under section
1395w–21
(g)(3)(B) of this title (and as applied under this part under section
1395w–101
(b)(1)(B)(v) of this title) for a period specified by the Secretary.
(E)
Inclusion of costs of applicable drugs under medicare coverage gap discount program
In applying subparagraph (A), incurred costs shall include the negotiated price (as defined in paragraph (6) of section
1395w–114a
(g) of this title) of an applicable drug (as defined in paragraph (2) of such section) of a manufacturer that is furnished to an applicable beneficiary (as defined in paragraph (1) of such section) under the Medicare coverage gap discount program under section
1395w–114a of this title, regardless of whether part of such costs were paid by a manufacturer under such program, except that incurred costs shall not include the portion of the negotiated price that represents the reduction in coinsurance resulting from the application of paragraph (2)(D).
(5)
Construction
Nothing in this part shall be construed as preventing a PDP sponsor or an MA organization offering an MA–PD plan from reducing to zero the cost-sharing otherwise applicable to preferred or generic drugs.
(6)
Annual percentage increase
The annual percentage increase specified in this paragraph for a year is equal to the annual percentage increase in average per capita aggregate expenditures for covered part D drugs in the United States for part D eligible individuals, as determined by the Secretary for the 12-month period ending in July of the previous year using such methods as the Secretary shall specify.
(c)
Alternative prescription drug coverage requirements
A prescription drug plan or an MA–PD plan may provide a different prescription drug benefit design from standard prescription drug coverage so long as the Secretary determines (consistent with section
1395w–111
(c) of this title) that the following requirements are met and the plan applies for, and receives, the approval of the Secretary for such benefit design:
(1)
Assuring at least actuarially equivalent coverage
(A)
Assuring equivalent value of total coverage
The actuarial value of the total coverage is at least equal to the actuarial value of standard prescription drug coverage.
(B)
Assuring equivalent unsubsidized value of coverage
The unsubsidized value of the coverage is at least equal to the unsubsidized value of standard prescription drug coverage. For purposes of this subparagraph, the unsubsidized value of coverage is the amount by which the actuarial value of the coverage exceeds the actuarial value of the subsidy payments under section
1395w–115 of this title with respect to such coverage.
(C)
Assuring standard payment for costs at initial coverage limit
The coverage is designed, based upon an actuarially representative pattern of utilization, to provide for the payment, with respect to costs incurred that are equal to the initial coverage limit under subsection (b)(3) of this section for the year, of an amount equal to at least the product of—
(d)
Access to negotiated prices
(1)
Access
(A)
In general
Under qualified prescription drug coverage offered by a PDP sponsor offering a prescription drug plan or an MA organization offering an MA–PD plan, the sponsor or organization shall provide enrollees with access to negotiated prices used for payment for covered part D drugs, regardless of the fact that no benefits may be payable under the coverage with respect to such drugs because of the application of a deductible or other cost-sharing or an initial coverage limit (described in subsection (b)(3) of this section).
(B)
Negotiated prices
For purposes of this part, negotiated prices shall take into account negotiated price concessions, such as discounts, direct or indirect subsidies, rebates, and direct or indirect remunerations, for covered part D drugs, and include any dispensing fees for such drugs.
(C)
Medicaid-related provisions
The prices negotiated by a prescription drug plan, by an MA–PD plan with respect to covered part D drugs, or by a qualified retiree prescription drug plan (as defined in section
1395w–132
(a)(2) of this title) with respect to such drugs on behalf of part D eligible individuals, 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.
(2)
Disclosure
A PDP sponsor offering a prescription drug plan or an MA organization offering an MA–PD plan shall disclose to the Secretary (in a manner specified by the Secretary) the aggregate negotiated price concessions described in paragraph (1)(B) made available to the sponsor or organization by a manufacturer which are passed through in the form of lower subsidies, lower monthly beneficiary prescription drug premiums, and lower prices through pharmacies and other dispensers. The provisions of section
1396r–8
(b)(3)(D) of this title apply to information disclosed to the Secretary under this paragraph.
(3)
Audits
To protect against fraud and abuse and to ensure proper disclosures and accounting under this part and in accordance with section
1395w–27
(d)(2)(B) of this title (as applied under section
1395w–112
(b)(3)(C) of this title), the Secretary may conduct periodic audits, directly or through contracts, of the financial statements and records of PDP sponsors with respect to prescription drug plans and MA organizations with respect to MA–PD plans.
(e)
Covered part D drug defined
(1)
In general
Except as provided in this subsection, for purposes of this 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; or
(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),
and such term includes a vaccine licensed under section
262 of this title (and, for vaccines administered on or after January 1, 2008, its administration) and any use of a covered part D drug for a medically accepted indication (as defined in paragraph (4)).
(2)
Exclusions
(A)
In general
Such term does not include drugs or classes of drugs, or their medical uses, which may be excluded from coverage or otherwise restricted under section
1396r–8
(d)(2) of this title, other than subparagraph (E) of such section (relating to smoking cessation agents), other than subparagraph (I) of such section (relating to barbiturates) if the barbiturate is used in the treatment of epilepsy, cancer, or a chronic mental health disorder, and other than subparagraph (J) of such section (relating to benzodiazepines), or under section
1396r–8
(d)(3) of this title, as such sections were in effect on December 8, 2003. Such term also does not include a drug when used for the treatment of sexual or erectile dysfunction, unless such drug were used to treat a condition, other than sexual or erectile dysfunction, for which the drug has been approved by the Food and Drug Administration.
(B)
Medicare covered drugs
A drug prescribed for a part D eligible individual that would otherwise be a covered part D drug under this part shall not be so considered if payment for such drug as so prescribed and dispensed or administered with respect to that individual is available (or would be available but for the application of a deductible) under part A or B of this subchapter for that individual.
(3)
Application of general exclusion provisions
A prescription drug plan or an MA–PD plan may exclude from qualified prescription drug coverage any covered part D drug—
Such exclusions are determinations subject to reconsideration and appeal pursuant to subsections (g) and (h), respectively, of section
1395w–104 of this title.
(4)
Medically accepted indication defined
(A)
In general
For purposes of paragraph (1), 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
(B)
Conflict of interest
On and after January 1, 2010, subparagraph (A)(i)(II) shall not apply unless the compendia described in section
1396r–8
(g)(1)(B)(i)(III) of this title meets
[1]
the requirement in the third sentence of section
1395x
(t)(2)(B) of this title.
(C)
Update
For purposes of applying subparagraph (A)(ii), the Secretary shall revise the list of compendia described in section
1396r–8
(g)(1)(B)(i) of this title as is appropriate for identifying medically accepted indications for drugs. Any such revision shall be done in a manner consistent with the process for revising compendia under section
1395x
(t)(2)(B) of this title.
[1] So in original. Probably should be “meet”.
Source
(Aug. 14, 1935, ch. 531, title XVIII, § 1860D–2, as added Pub. L. 108–173, title I, § 101(a)(2),Dec. 8, 2003, 117 Stat. 2075; amended Pub. L. 109–91, title I, § 103(a),Oct. 20, 2005, 119 Stat. 2092; Pub. L. 109–432, div. B, title II, § 202(b),Dec. 20, 2006, 120 Stat. 2986; Pub. L. 110–275, title I, §§ 175(a),
182(a)(1),July 15, 2008, 122 Stat. 2581, 2583; Pub. L. 111–148, title III, §§ 3301(c)(1),
3314(a),
3315,Mar. 23, 2010, 124 Stat. 467, 478, 479; Pub. L. 111–152, title I, § 1101(a)(2), (b)(3), (d),Mar. 30, 2010, 124 Stat. 1037–1039.)
References in Text
Section 1101(d)(1) of the Health Care and Education Reconciliation Act of 2010, referred to in subsec. (b)(4)(B)(i)(V), is section 1101(d)(1) ofPub. L. 111–152, which amended this section.
The Public Health Service Act, referred to in subsec. (b)(4)(C)(iii)(IV), is act July 1, 1944, ch. 373, 58 Stat. 682. Part B of title XXVI of the Act is classified generally to part B (§ 300ff–21 et seq.) of subchapter
XXIV of chapter
6A of this title. For complete classification of this Act to the Code, see Short Title note set out under section
201 of this title and Tables.
Amendments
2010—Subsec. (b)(2)(A). Pub. L. 111–152, § 1101(b)(3)(A), substituted “Subject to subparagraphs (C) and (D), the coverage” for “The coverage”.
Subsec. (b)(2)(B). Pub. L. 111–152, § 1101(b)(3)(B), substituted “subparagraphs (A)(ii), (C), and (D)” for “subparagraph (A)(ii)”.
Subsec. (b)(2)(C), (D). Pub. L. 111–152, § 1101(b)(3)(C), added subpars. (C) and (D).
Subsec. (b)(3)(A). Pub. L. 111–152, § 1101(b)(3)(D), substituted “paragraphs (2)(C), (2)(D), and (4)” for “paragraph (4)”.
Pub. L. 111–148, § 3315(1), which directed substitution of “paragraphs (4) and (7)” for “paragraph (4)” in introductory provisions, was repealed by Pub. L. 111–152, § 1101(a)(2). See Construction of 2010 Amendment note below.
Subsec. (b)(4)(B)(i)(II) to (VI). Pub. L. 111–152, § 1101(d)(1), added subcls. (II) to (V) and redesignated former subcl. (II) as (VI).
Subsec. (b)(4)(C). Pub. L. 111–148, § 3314(a), in cl. (ii), substituted “subject to clause (iii), such costs shall be treated as incurred only if” for “such costs shall be treated as incurred only if” and struck out “, under section
1395w–114 of this title, or under a State Pharmaceutical Assistance Program” after “on behalf of the individual),”, and added cl. (iii).
Pub. L. 111–148, § 3301(c)(1)(A), substituted “Except as provided in subparagraph (E), in applying” for “In applying” in introductory provisions.
Subsec. (b)(4)(E). Pub. L. 111–152, § 1101(b)(3)(E), inserted before period at end “, except that incurred costs shall not include the portion of the negotiated price that represents the reduction in coinsurance resulting from the application of paragraph (2)(D)”.
Pub. L. 111–148, § 3301(c)(1)(B), added subpar. (E).
Subsec. (b)(7). Pub. L. 111–152, § 1101(d)(2), added par. (7).
Pub. L. 111–148, § 3315(2), which directed addition of par. (7), was repealed by Pub. L. 111–152, § 1101(a)(2). As enacted, text read as follows:
“(A) In general.—For the plan year beginning on January 1, 2010, the initial coverage limit described in paragraph (3)(B) otherwise applicable shall be increased by $500.
“(B) Application.—In applying subparagraph (A)—
“(i) except as otherwise provided in this subparagraph, there shall be no change in the premiums, bids, or any other parameters under this part or part C;
“(ii) costs that would be treated as incurred costs for purposes of applying paragraph (4) but for the application of subparagraph (A) shall continue to be treated as incurred costs;
“(iii) the Secretary shall establish procedures, which may include a reconciliation process, to fully reimburse PDP sponsors with respect to prescription drug plans and MA organizations with respect to MA–PD plans for the reduction in beneficiary cost sharing associated with the application of subparagraph (A);
“(iv) the Secretary shall develop an estimate of the additional increased costs attributable to the application of this paragraph for increased drug utilization and financing and administrative costs and shall use such estimate to adjust payments to PDP sponsors with respect to prescription drug plans under this part and MA organizations with respect to MA–PD plans under part C; and
“(v) the Secretary shall establish procedures for retroactive reimbursement of part D eligible individuals who are covered under such a plan for costs which are incurred before the date of initial implementation of subparagraph (A) and which would be reimbursed under such a plan if such implementation occurred as of January 1, 2010.
“(C) No effect on subsequent years.—The increase under subparagraph (A) shall only apply with respect to the plan year beginning on January 1, 2010, and the initial coverage limit for plan years beginning on or after January 1, 2011, shall be determined as if subparagraph (A) had never applied.”
See Construction of 2010 Amendment note below.
2008—Subsec. (e)(1). Pub. L. 110–275, § 182(a)(1)(A), substituted “(as defined in paragraph (4))” for “(as defined in section
1396r–8
(k)(6) of this title)” in concluding provisions.
Subsec. (e)(2)(A). Pub. L. 110–275, § 175(a), inserted “other than subparagraph (I) of such section (relating to barbiturates) if the barbiturate is used in the treatment of epilepsy, cancer, or a chronic mental health disorder, and other than subparagraph (J) of such section (relating to benzodiazepines),” after “agents),”.
Subsec. (e)(4). Pub. L. 110–275, § 182(a)(1)(B), which directed amendment of subsec. (e)(1) in the matter following subpar. (B) by adding par. (4) at the end, was executed by adding par. (4) at end of subsec. (e), to reflect the probable intent of Congress.
2006—Subsec. (e)(1). Pub. L. 109–432inserted “(and, for vaccines administered on or after January 1, 2008, its administration)” after “section
262 of this title” in concluding provisions.
2005—Subsec. (e)(2)(A). Pub. L. 109–91, § 103(a)(2), inserted at end “Such term also does not include a drug when used for the treatment of sexual or erectile dysfunction, unless such drug were used to treat a condition, other than sexual or erectile dysfunction, for which the drug has been approved by the Food and Drug Administration.”
Pub. L. 109–91, § 103(a)(1), inserted before period at end “, as such sections were in effect on December 8, 2003”.
Effective Date of 2010 Amendment
Pub. L. 111–148, title III, § 3301(c)(2),Mar. 23, 2010, 124 Stat. 468, provided that: “The amendments made by this subsection [amending this section] shall apply to costs incurred on or after July 1, 2010.”
Pub. L. 111–148, title III, § 3314(b),Mar. 23, 2010, 124 Stat. 479, provided that: “The amendments made by subsection (a) [amending this section] shall apply to costs incurred on or after January 1, 2011.”
Effective Date of 2008 Amendment
Pub. L. 110–275, title I, § 175(b),July 15, 2008, 122 Stat. 2581, provided that: “The amendments made by subsection (a) [amending this section] shall apply to prescriptions dispensed on or after January 1, 2013.”
Pub. L. 110–275, title I, § 182(a)(2),July 15, 2008, 122 Stat. 2583, provided that: “The amendments made by this subsection [amending this section] shall apply to plan years beginning on or after January 1, 2009.”
Effective Date of 2005 Amendment
Pub. L. 109–91, title I, § 103(c),Oct. 20, 2005, 119 Stat. 2092, provided that: “The amendment made by subsection (a)(1) [amending this section] shall take effect as if included in the enactment of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Public Law 108–173) and the amendment made by subsection (a)(2) [amending this section] shall apply to coverage for drugs dispensed on or after January 1, 2007.”
Construction of 2010 Amendment
Pub. L. 111–152, title I, § 1101(a)(2),Mar. 30, 2010, 124 Stat. 1037, provided that: “Section 3315 of the Patient Protection and Affordable Care Act [section 3315 ofPub. L. 111–148, amending this section] (including the amendments made by such section) is repealed, and any provision of law amended or repealed by such sections [sic] is hereby restored or revived as if such section had not been enacted into law.”
Construction
Pub. L. 109–91, title I, § 103(b),Oct. 20, 2005, 119 Stat. 2092, provided that: “Nothing in this section [amending this section and enacting provisions set out as a note under this section] shall be construed as preventing a prescription drug plan or an MA–PD plan from providing coverage of drugs for the treatment of sexual or erectile dysfunction as supplemental prescription drug coverage under section 1860D–2(a)(2)(A)(ii) of the Social Security Act (42 U.S.C. 1395w–102
(a)(2)(A)(ii)).”
Payment for Administration of Part D Vaccines in 2007
Pub. L. 109–432, div. B, title II, § 202(a),Dec. 20, 2006, 120 Stat. 2986, provided that: “Notwithstanding any other provision of law, in the case of a vaccine that is a covered part D drug under section 1860D–2(e) of the Social Security Act (42 U.S.C. 1395w–102
(e)) and that is administered during 2007, the administration of such vaccine shall be paid under part B of title XVIII of such Act [part B of this subchapter] as if it were the administration of a vaccine described in section 1861(s)(10)(B) of such Act (42 U.S.C. 1395w
(s)(10)(B) [probably should be 1395x(s)(10)(B)]).”
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