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H.R.5376 inflation-reduction-act-revised.csv
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Item Page_Lines Para Text
1 1.1 - 1.2 TITLE I COMMITTEE ON FINANCE
2 1.3 - 1.3 TITLE I Subtitle A Deficit Reduction
3 1.4 - 1.9 TITLE I Subtitle A SEC. 10001. AMENDMENT OF 1986 CODE. Except as otherwise expressly provided, whenever in this subtitle an amendment or repeal is expressed in terms of an amendment to, or repeal of, a section or other provision, the reference shall be considered to be made to a section or other provision of the Internal Revenue Code of 1986.
4 2.1 - 2.1 TITLE I Subtitle A PART 1 CORPORATE TAX REFORM
5 2.2 - 2.2 TITLE I Subtitle A PART 1 SEC. 10101. CORPORATE ALTERNATIVE MINIMUM TAX.
6 2.3 - 2.3 SEC. 10101.(a) IMPOSITION OF TAX.
7 2.4 - 2.5 SEC. 10101.(a)(1) IN GENERAL. Paragraph (2) of section 55(b) is amended to read as follows:
8 2.6 - 2.6 [SEC. 10101.(a)(1)] (2) CORPORATIONS.
9 2.7 - 2.10 [SEC. 10101.(a)(1)] (2)(A) APPLICABLE CORPORATIONS. In the case of an applicable corporation, the tentative minimum tax for the taxable year shall be the excess of
10 2.11 - 2.13 [SEC. 10101.(a)(1)] (2)(A)(i) 15 percent of the adjusted financial statement income for the taxable year (as determined under section 56A), over
11 2.14 - 2.15 [SEC. 10101.(a)(1)] (2)(A)(ii) the corporate AMT foreign tax credit for the taxable year.
12 2.16 - 2.19 [SEC. 10101.(a)(1)] (2)(B) OTHER CORPORATIONS. In the case of any corporation which is not an applicable corporation, the tentative minimum tax for the taxable year shall be zero.’’.
13 2.20 - 2.22 SEC. 10101.(a)(2) APPLICABLE CORPORATION. Section 59 is amended by adding at the end the following new subsection:
14 2.23 - 2.24 [SEC. 10101.(a)(2)] (k) APPLICABLE CORPORATION. For purposes of this part
15 2.25 - 2.25 [SEC. 10101.(a)(2)] (k)(1) APPLICABLE CORPORATION DEFINED.
16 3.1 - 3.8 [SEC. 10101.(a)(2)] (k)(1)(A) IN GENERAL. The term ‘applicable corporation’ means, with respect to any taxable year, any corporation (other than an S corporation, a regulated investment company, or a real estate investment trust) which meets the average annual adjusted financial statement income test of subparagraph (B) for one or more taxable years which
17 3.9 - 3.9 [SEC. 10101.(a)(2)] (k)(1)(A)(i) are prior to such taxable year, and
18 3.10 - 3.10 [SEC. 10101.(a)(2)] (k)(1)(A)(ii) end after December 31, 2021.
19 3.11 - 3.13 [SEC. 10101.(a)(2)] (k)(1)(B) AVERAGE ANNUAL ADJUSTED FINANCIAL STATEMENT INCOME TEST. For purposes of this subsection
20 3.14 - 3.21 [SEC. 10101.(a)(2)] (k)(1)(B)(i) a corporation meets the average annual adjusted financial statement income test for a taxable year if the average annual adjusted financial statement income of such corporation (determined without regard to section 56A(d)) for the 3-taxable-year period ending with such taxable year exceeds $1,000,000,000, and
21 3.22 - 4.2 [SEC. 10101.(a)(2)] (k)(1)(B)(ii) in the case of a corporation described in paragraph (2), such corporation meets the average annual adjusted financial statement income test for a taxable year if
22 4.3 - 4.6 [SEC. 10101.(a)(2)] (k)(1)(B)(ii)(I) the corporation meets the requirements of clause (i) for such taxable year (determined after the application of paragraph (2)), and
23 4.7 - 4.14 [SEC. 10101.(a)(2)] (k)(1)(B)(ii)(II) the average annual adjusted financial statement income of such corporation (determined without regard to the application of paragraph (2) and without regard to section 56A(d)) for the 3-taxable-year-period ending with such taxable year is $100,000,000 or more.
24 4.15 - 4.19 [SEC. 10101.(a)(2)] (k)(1)(C) EXCEPTION. Notwithstanding subparagraph (A), the term ‘applicable corporation’ shall not include any corporation which otherwise meets the requirements of subparagraph (A) if
25 4.20 - 4.20 [SEC. 10101.(a)(2)] (k)(1)(C)(i) such corporation
26 4.21 - 4.22 [SEC. 10101.(a)(2)] (k)(1)(C)(i)(I) has a change in ownership, or
27 4.23 - 5.7 [SEC. 10101.(a)(2)] (k)(1)(C)(i)(II) has a specified number (to be determined by the Secretary and which shall, as appropriate, take into account the facts and circumstances of the taxpayer) of consecutive taxable years, including the most recent taxable year, in which the corporation does not meet the average annual adjusted financial statement income test of subparagraph (B), and
28 5.8 - 5.19 [SEC. 10101.(a)(2)] (k)(1)(C)(ii) the Secretary determines that it would not be appropriate to continue to treat such corporation as an applicable corporation. The preceding sentence shall not apply to any corporation if, after the Secretary makes the determination described in clause (ii), such corporation meets the average annual adjusted financial statement income test of subparagraph (B) for any taxable year beginning after the first taxable year for which such determination applies.
30 5.20 - 5.21 [SEC. 10101.(a)(2)] (k)(1)(D) SPECIAL RULES FOR DETERMINING APPLICABLE CORPORATION STATUS.
31 5.22 - 6.10 [SEC. 10101.(a)(2)] (k)(1)(D)(i) IN GENERAL. Solely for purposes of determining whether a corporation is an applicable corporation under this paragraph, all adjusted financial statement income of persons treated as a single employer with such corporation under subsection (a) or (b) of section 52 (determined with the modifications described in clause (ii)) shall be treated as adjusted financial statement income of such corporation, and adjusted financial statement income of such corporation shall be determined without regard to paragraphs (2)(D)(i) and (11) of section 56A(c).
32 6.11 - 6.12 [SEC. 10101.(a)(2)] (k)(1)(D)(ii) MODIFICATIONS. For purposes of this subparagraph
33 6.13 - 6.15 [SEC. 10101.(a)(2)] (k)(1)(D)(ii)(I) section 52(a) shall be applied by substituting ‘component members’ for ‘members’, and
34 6.16 - 6.23 [SEC. 10101.(a)(2)] (k)(1)(D)(ii)(II) for purposes of applying section 52(b), the term ‘trade or business’ shall include any activity treated as a trade or business under paragraph (5) or (6) of section 469(c) (determined without regard to the phrase ‘To the extent provided in regulations’ in such paragraph (6)).
35 6.24 - 7.4 [SEC. 10101.(a)(2)] (k)(1)(D)(iii) COMPONENT MEMBER. For purposes of this subparagraph, the term ‘component member’ has the meaning given such term by section 1563(b), except that the determination shall be made without regard to section 1563(b)(2).
36 7.5 - 7.5 [SEC. 10101.(a)(2)] (k)(1)(E) OTHER SPECIAL RULES.
37 7.6 - 7.11 [SEC. 10101.(a)(2)] (k)(1)(E)(i) CORPORATIONS IN EXISTENCE FOR LESS THAN 3 YEARS. If the corporation was in existence for less than 3-taxable years, subparagraph (B) shall be applied on the basis of the period during which such corporation was in existence.
38 7.12 - 7.18 [SEC. 10101.(a)(2)] (k)(1)(E)(ii) SHORT TAXABLE YEARS. Adjusted financial statement income for any taxable year of less than 12 months shall be annualized by multiplying the adjusted financial statement income for the short period by 12 and dividing the result by the number of months in the short period.
39 7.19 - 7.23 [SEC. 10101.(a)(2)] (k)(1)(E)(iii) TREATMENT OF PREDECESSORS. Any reference in this subparagraph to a corporation shall include a reference to any predecessor of such corporation.
40 7.24 - 7.25 [SEC. 10101.(a)(2)] (k)(2) SPECIAL RULE FOR FOREIGN-PARENTED MULTINATIONAL GROUPS.
41 8.1 - 8.14 [SEC. 10101.(a)(2)] (k)(2)(A) IN GENERAL. If a corporation is a member of a foreign-parented multinational group for any taxable year, then, solely for purposes of determining whether such corporation meets the average annual adjusted financial statement income test under paragraph (1)(B)(ii)(I) for such taxable year, the adjusted financial statement income of such corporation for such taxable year shall include the adjusted financial statement income of all members of such group. Solely for purposes of this subparagraph, adjusted financial statement income shall be determined without regard to paragraphs (2)(D)(i), (3), (4), and (11) of section 56A(c).
44 8.15 - 8.19 [SEC. 10101.(a)(2)] (k)(2)(B) FOREIGN-PARENTED MULTINATIONAL GROUP. For purposes of subparagraph (A), the term ‘foreign-parented multinational group’ means, with respect to any taxable year, two or more entities if
45 8.20 - 8.22 [SEC. 10101.(a)(2)] (k)(2)(B)(i) at least one entity is a domestic corporation and another entity is a foreign corporation,
46 8.23 - 8.25 [SEC. 10101.(a)(2)] (k)(2)(B)(ii) such entities are included in the same applicable financial statement with respect to such year, and
47 9.1 - 9.1 [SEC. 10101.(a)(2)] (k)(2)(B)(iii) either
48 9.2 - 9.3 [SEC. 10101.(a)(2)] (k)(2)(B)(iii)(I) the common parent of such entities is a foreign corporation, or
49 9.4 - 9.7 [SEC. 10101.(a)(2)] (k)(2)(B)(iii)(II) if there is no common parent, the entities are treated as having a common parent which is a foreign corporation under subparagraph (D).
50 9.8 - 9.15 [SEC. 10101.(a)(2)] (k)(2)(C) FOREIGN CORPORATIONS ENGAGED IN A TRADE OR BUSINESS WITHIN THE UNITED STATES. For purposes of this paragraph, if a foreign corporation is engaged in a trade or business within the United States, such trade or business shall be treated as a separate domestic corporation that is wholly owned by the foreign corporation.
51 9.16 - 9.19 [SEC. 10101.(a)(2)] (k)(2)(D) OTHER RULES. The Secretary shall, applying the principles of this section, prescribe rules for the application of this paragraph, including rules for the determination of
52 9.20 - 9.23 [SEC. 10101.(a)(2)] (k)(2)(D)(i) the entities (if any) which are to be to be treated under subparagraph (B)(iii)(II) as having a common parent which is a foreign corporation,
54 9.24 - 9.25 [SEC. 10101.(a)(2)] (k)(2)(D)(ii) the entities to be included in a foreign-parented multinational group, and
55 10.1 - 10.2 [SEC. 10101.(a)(2)] (k)(2)(D)(iii) the common parent of a foreignparented multinational group.
56 10.3 - 10.6 [SEC. 10101.(a)(2)] (k)(3) REGULATIONS OR OTHER GUIDANCE. The Secretary shall provide regulations or other guidance for the purposes of carrying out this subsection, including regulations or other guidance
57 10.7 - 10.12 [SEC. 10101.(a)(2)] (k)(3)(A) providing a simplified method for determining whether a corporation meets the requirements of paragraph (1), and ‘‘’(B) addressing the application of this subsection to a corporation that experiences a change in ownership.’’.
58 10.13 - 10.17 SEC. 10101.(a)(3) REDUCTION FOR BASE EROSION AND ANTIABUSE TAX. Section 55(a)(2) is amended by inserting ‘‘plus, in the case of an applicable corporation, the tax imposed by section 59A’’ before the period at the end.
59 10.18 - 10.18 SEC. 10101.(a)(4) CONFORMING AMENDMENTS.
60 10.19 - 10.21 SEC. 10101.(a)(4)(A) Section 55(a) is amended by striking ‘‘In the case of a taxpayer other than a corporation, there’’ and inserting ‘‘There’’.
61 10.22 - 10.22 SEC. 10101.(a)(4)(B)(i) Section 55(b)(1) is amended
62 10.23 - 10.25 SEC. 10101.(a)(4)(B)(i)(I) by striking so much as precedes subparagraph (A) and inserting the following:
63 11.1 - 11.2 [SEC. 10101.(a)(4)(B)(i)(I)] (1) NONCORPORATE TAXPAYERS. In the case of a taxpayer other than a corporation ’’, and
64 11.3 - 11.4 SEC. 10101.(a)(4)(B)(i)(II) by adding at the end the following new subparagraph:
65 11.5 - 11.8 [SEC. 10101.(a)(4)(B)(i)(II)] (D) ALTERNATIVE MINIMUM TAXABLE INCOME. The term ‘alternative minimum taxable income’ means the taxable income of the taxpayer for the taxable year
66 11.9 - 11.10 [SEC. 10101.(a)(4)(B)(i)(II)] (D)(i) determined with the adjustments provided in section 56 and section 58, and
67 11.11 - 11.20 [SEC. 10101.(a)(4)(B)(i)(II)] (D)(ii) increased by the amount of the items of tax preference described in section 57. If a taxpayer is subject to the regular tax, such taxpayer shall be subject to the tax imposed by this section (and, if the regular tax is determined by reference to an amount other than taxable income, such amount shall be treated as the taxable income of such taxpayer for purposes of the preceding sentence).’’.
68 11.21 - 11.22 SEC. 10101.(a)(4)(B)(ii) Section 860E(a)(4) is amended by striking ‘‘55(b)(2)’’ and inserting ‘‘55(b)(1)(D)’’.
69 11.23 - 11.24 SEC. 10101.(a)(4)(B)(iii) Section 897(a)(2)(A)(i) is amended by striking ‘‘55(b)(2)’’ and inserting ‘‘55(b)(1)(D)’’.
70 12.1 - 12.4 SEC. 10101.(a)(4)(C) Section 11(d) is amended by striking ‘‘the tax imposed by subsection (a)’’ and inserting ‘‘the taxes imposed by subsection (a) and section 55’’.
71 12.5 - 12.6 SEC. 10101.(a)(4)(D) Section 12 is amended by adding at the end the following new paragraph:
72 12.7 - 12.8 [SEC. 10101.(a)(4)(D)] (5) For alternative minimum tax, see section 55.’’.
73 12.9 - 12.10 SEC. 10101.(a)(4)(E) Section 882(a)(1) is amended by inserting ‘‘, 55,’’ after ‘‘section 11’’.
74 12.11 - 12.12 SEC. 10101.(a)(4)(F) Section 6425(c)(1)(A) is amended to read as follows:
75 12.13 - 12.13 [SEC. 10101.(a)(4)(F)] (A) the sum of
76 12.14 - 12.16 [SEC. 10101.(a)(4)(F)] (A)(i) the tax imposed by section 11 or subchapter L of chapter 1, whichever is applicable, plus
77 12.17 - 12.18 [SEC. 10101.(a)(4)(F)] (A)(ii) the tax imposed by section 55, plus
78 12.19 - 12.20 [SEC. 10101.(a)(4)(F)] (A)(iii) the tax imposed by section 59A, over’’.
79 12.21 - 12.25 SEC. 10101.(a)(4)(G) Section 6655(e)(2) is amended by inserting ‘‘, adjusted financial statement income (as defined in section 56A),’’ before ‘‘and modified taxable income’’ each place it appears in subparagraphs (A)(i) and (B)(i).
80 13.1 - 13.4 SEC. 10101.(a)(4)(H) Section 6655(g)(1)(A) is amended by redesignating clauses (ii) and (iii) as clauses (iii) and (iv), respectively, and by inserting after clause (i) the following new clause:
82 13.5 - 13.5 [SEC. 10101.(a)(4)(H)] (ii) the tax imposed by section 55,’’.
83 13.6 - 13.6 SEC. 10101.(b) ADJUSTED FINANCIAL STATEMENT INCOME.
84 13.7 - 13.9 SEC. 10101.(b)(1) IN GENERAL. Part VI of subchapter A of chapter 1 is amended by inserting after section 56 the following new section:
85 13.10 - 13.10 [SEC. 10101.(b)(1)] SEC. 56A. ADJUSTED FINANCIAL STATEMENT INCOME.
86 13.11 - 13.16 [SEC. 10101.(b)(1)] SEC. 56A.(a) IN GENERAL. For purposes of this part, the term ‘adjusted financial statement income’ means, with respect to any corporation for any taxable year, the net income or loss of the taxpayer set forth on the taxpayer’s applicable financial statement for such taxable year, adjusted as provided in this section.
87 13.17 - 13.22 [SEC. 10101.(b)(1)] SEC. 56A.(b) APPLICABLE FINANCIAL STATEMENT. For purposes of this section, the term ‘applicable financial statement’ means, with respect to any taxable year, an applicable financial statement (as defined in section 451(b)(3) or as specified by the Secretary in regulations or other guidance) which covers such taxable year.
88 13.23 - 13.23 [SEC. 10101.(b)(1)] SEC. 56A.(c) GENERAL ADJUSTMENTS.
89 13.24 - 14.3 [SEC. 10101.(b)(1)] SEC. 56A.(c)(1) STATEMENTS COVERING DIFFERENT TAXABLE YEARS. Appropriate adjustments shall be made in adjusted financial statement income in any case in which an applicable financial statement covers a period other than the taxable year.
90 14.4 - 14.4 [SEC. 10101.(b)(1)] SEC. 56A.(c)(2) SPECIAL RULES FOR RELATED ENTITIES.
91 14.5 - 14.9 [SEC. 10101.(b)(1)] SEC. 56A.(c)(2)(A) CONSOLIDATED FINANCIAL STATEMENTS. If the financial results of a taxpayer are reported on the applicable financial statement for a group of entities, rules similar to the rules of section 451(b)(5) shall apply.
92 14.10 - 14.18 [SEC. 10101.(b)(1)] SEC. 56A.(c)(2)(B) CONSOLIDATED RETURNS. Except as provided in regulations prescribed by the Secretary, if the taxpayer is part of an affiliated group of corporations filing a consolidated return for any taxable year, adjusted financial statement income for such group for such taxable year shall take into account items on the group’s applicable financial statement which are properly allocable to members of such group.
93 14.19 - 15.8 [SEC. 10101.(b)(1)] SEC. 56A.(c)(2)(C) TREATMENT OF DIVIDENDS AND OTHER AMOUNTS. In the case of any corporation which is not included on a consolidated return with the taxpayer, adjusted financial statement income of the taxpayer with respect to such other corporation shall be determined by only taking into account the dividends received from such other corporation (reduced to the extent provided by the Secretary in regulations or other guidance) and other amounts which are includible in gross income or deductible as a loss under this chapter (other than amounts required to be included under sections 951 and 951A or such other amounts as provided by the Secretary) with respect to such other corporation.
94 15.9 - 15.9 [SEC. 10101.(b)(1)] SEC. 56A.(c)(2)(D) TREATMENT OF PARTNERSHIPS.
95 15.10 - 15.17 [SEC. 10101.(b)(1)] SEC. 56A.(c)(2)(D)(i) IN GENERAL. Except as provided by the Secretary, if the taxpayer is a partner in a partnership, adjusted financial statement income of the taxpayer with respect to such partnership shall be adjusted to only take into account the taxpayer’s distributive share of adjusted financial statement income of such partnership.
96 15.18 - 15.25 [SEC. 10101.(b)(1)] SEC. 56A.(c)(2)(D)(ii) ADJUSTED FINANCIAL STATEMENT INCOME OF PARTNERSHIPS. For the purposes of this part, the adjusted financial statement income of a partnership shall be the partnership’s net income or loss set forth on such partnership’s applicable financial statement (adjusted under rules similar to the rules of this section).
97 16.1 - 16.2 [SEC. 10101.(b)(1)] SEC. 56A.(c)(3) ADJUSTMENTS TO TAKE INTO ACCOUNT CERTAIN ITEMS OF FOREIGN INCOME.
98 16.3 - 16.19 [SEC. 10101.(b)(1)] SEC. 56A.(c)(3)(A) IN GENERAL. If, for any taxable year, a taxpayer is a United States shareholder of one or more controlled foreign corporations, the adjusted financial statement income of such taxpayer with respect to such controlled foreign corporation (as determined under paragraph (2)(C)) shall be adjusted to also take into account such taxpayer’s pro rata share (determined under rules similar to the rules under section 951(a)(2)) of items taken into account in computing the net income or loss set forth on the applicable financial statement (as adjusted under rules similar to those that apply in determining adjusted financial statement income) of each such controlled foreign corporation with respect to which such taxpayer is a United States shareholder.
100 16.20 - 16.23 [SEC. 10101.(b)(1)] SEC. 56A.(c)(3)(B) NEGATIVE ADJUSTMENTS. In any case in which the adjustment determined under subparagraph (A) would result in a negative adjustment for such taxable year
101 17.1 - 17.3 [SEC. 10101.(b)(1)] SEC. 56A.(c)(3)(B)(i) no adjustment shall be made under this paragraph for such taxable year, and
102 17.4 - 17.9 [SEC. 10101.(b)(1)] SEC. 56A.(c)(3)(B)(ii) the amount of the adjustment determined under this paragraph for the succeeding taxable year (determined without regard to this paragraph) shall be reduced by an amount equal to the negative adjustment for such taxable year.
103 17.10 - 17.13 [SEC. 10101.(b)(1)] SEC. 56A.(c)(4) EFFECTIVELY CONNECTED INCOME. In the case of a foreign corporation, to determine adjusted financial statement income, the principles of section 882 shall apply.
104 17.14 - 18.9 [SEC. 10101.(b)(1)] SEC. 56A.(c)(5) ADJUSTMENTS FOR CERTAIN TAXES. Adjusted financial statement income shall be appropriately adjusted to disregard any Federal income taxes, or income, war profits, or excess profits taxes (within the meaning of section 901) with respect to a foreign country or possession of the United States, which are taken into account on the taxpayer’s applicable financial statement. To the extent provided by the Secretary, the preceding sentence shall not apply to income, war profits, or excess profits taxes (within the meaning of section 901) that are imposed by a foreign country or possession of the United States and taken into account on the taxpayer’s applicable financial statement if the taxpayer does not choose to have the benefits of subpart A of part III of subchapter N for the taxable year. The Secretary shall prescribe such regulations or other guidance as may be necessary and appropriate to provide for the proper treatment of current and deferred taxes for purposes of this paragraph, including the time at which such taxes are properly taken into account.
105 18.10 - 18.14 [SEC. 10101.(b)(1)] SEC. 56A.(c)(6) ADJUSTMENT WITH RESPECT TO DISREGARDED ENTITIES. Adjusted financial statement income shall be adjusted to take into account any adjusted financial statement income of a disregarded entity owned by the taxpayer.
106 18.15 - 18.23 [SEC. 10101.(b)(1)] SEC. 56A.(c)(7) SPECIAL RULE FOR COOPERATIVES. In the case of a cooperative to which section 1381 applies, the adjusted financial statement income (determined without regard to this paragraph) shall be reduced by the amounts referred to in section 1382(b) (relating to patronage dividends and per-unit retain allocations) to the extent such amounts were not otherwise taken into account in determining adjusted financial statement income.
107 19.1 - 19.3 [SEC. 10101.(b)(1)] SEC. 56A.(c)(8) RULES FOR ALASKA NATIVE CORPORATIONS. Adjusted financial statement income shall be appropriately adjusted to allow
108 19.4 - 19.7 [SEC. 10101.(b)(1)] SEC. 56A.(c)(8)(A) cost recovery and depletion attributable to property the basis of which is determined under section 21(c) of the Alaska Native Claims Settlement Act (43 U.S.C. 1620(c)), and
109 19.8 - 19.12 [SEC. 10101.(b)(1)] SEC. 56A.(c)(8)(B) deductions for amounts payable made pursuant to section 7(i) or section 7(j) of such Act (43 U.S.C. 1606(i) and 1606(j)) only at such time as the deductions are allowed for tax purposes.
110 19.13 - 19.20 [SEC. 10101.(b)(1)] SEC. 56A.(c)(9) AMOUNTS ATTRIBUTABLE TO ELECTIONS FOR DIRECT PAYMENT OF CERTAIN CREDITS. Adjusted financial statement income shall be appropriately adjusted to disregard any amount treated as a payment against the tax imposed by subtitle A pursuant to an election under section 48D(d) or 6417, to the extent such amount was not otherwise taken into account under paragraph (5).
111 19.21 - 19.23 [SEC. 10101.(b)(1)] SEC. 56A.(c)(10) CONSISTENT TREATMENT OF MORTGAGE SERVICING INCOME OF TAXPAYER OTHER THAN A REGULATED INVESTMENT COMPANY.
112 19.24 - 20.4 [SEC. 10101.(b)(1)] SEC. 56A.(c)(10)(A) IN GENERAL. Adjusted financial statement income shall be adjusted so as not to include any item of income in connection with a mortgage servicing contract any earlier than when such income is included in gross income under any other provision of this chapter.
113 20.5 - 20.11 [SEC. 10101.(b)(1)] SEC. 56A.(c)(10)(B) RULES FOR AMOUNTS NOT REPRESENTING REASONABLE COMPENSATION. The Secretary shall provide regulations to prevent the avoidance of taxes imposed by this chapter with respect to amounts not representing reasonable compensation (as determined by the Secretary) with respect to a mortgage servicing contract.
114 20.12 - 20.13 [SEC. 10101.(b)(1)] SEC. 56A.(c)(11) ADJUSTMENT WITH RESPECT TO DEFINED BENEFIT PENSIONS.
115 20.14 - 20.17 [SEC. 10101.(b)(1)] SEC. 56A.(c)(11)(A) IN GENERAL. Except as otherwise provided in rules prescribed by the Secretary in regulations or other guidance, adjusted financial statement income shall be
116 20.18 - 20.22 [SEC. 10101.(b)(1)] SEC. 56A.(c)(11)(A)(i) adjusted to disregard any amount of income, cost, or expense that would otherwise be included on the applicable financial statement in connection with any covered benefit plan,
117 20.23 - 21.2 [SEC. 10101.(b)(1)] SEC. 56A.(c)(11)(A)(ii) increased by any amount of income in connection with any such covered benefit plan that is included in the gross income of the corporation under any other provision of this chapter, and
118 21.3 - 21.6 [SEC. 10101.(b)(1)] SEC. 56A.(c)(11)(A)(iii) reduced by deductions allowed under any other provision of this chapter with respect to any such covered benefit plan.
119 21.7 - 21.9 [SEC. 10101.(b)(1)] SEC. 56A.(c)(11)(B) COVERED BENEFIT PLAN. For purposes of this paragraph, the term ‘covered benefit plan’ means
120 21.10 - 21.15 [SEC. 10101.(b)(1)] SEC. 56A.(c)(11)(B)(i) a defined benefit plan (other than a multiemployer plan described in section 414(f)) if the trust which is part of such plan is an employees’ trust described in section 401(a) which is exempt from tax under section 501(a),
121 21.16 - 21.17 [SEC. 10101.(b)(1)] SEC. 56A.(c)(11)(B)(ii) any qualified foreign plan (as defined in section 404A(e)), or
122 21.18 - 21.20 [SEC. 10101.(b)(1)] SEC. 56A.(c)(11)(B)(iii) any other defined benefit plan which provides post-employment benefits other than pension benefits.
123 21.21 - 21.25 [SEC. 10101.(b)(1)] SEC. 56A.(c)(12) TAX-EXEMPT ENTITIES. In the case of an organization subject to tax under section 511, adjusted financial statement income shall be appropriately adjusted to only take into account any adjusted financial statement income
124 22.1 - 22.2 [SEC. 10101.(b)(1)] SEC. 56A.(c)(12)(A) of an unrelated trade or business (as defined in section 513) of such organization, or
125 22.3 - 22.6 [SEC. 10101.(b)(1)] SEC. 56A.(c)(12)(B) derived from debt-financed property (as defined in section 514) to the extent that income from such property is treated as unrelated business taxable income.
126 22.7 - 22.8 [SEC. 10101.(b)(1)] SEC. 56A.(c)(13) DEPRECIATION. Adjusted financial statement income shall be
127 22.9 - 22.13 [SEC. 10101.(b)(1)] SEC. 56A.(c)(13)(A) reduced by depreciation deductions allowed under section 167 with respect to property to which section 168 applies to the extent of the amount allowed as deductions in computing taxable income for the taxable year, and
128 22.14 - 22.14 [SEC. 10101.(b)(1)] SEC. 56A.(c)(13)(B) appropriately adjusted
129 22.15 - 22.18 [SEC. 10101.(b)(1)] SEC. 56A.(c)(13)(B)(i) to disregard any amount of depreciation expense that is taken into account on the taxpayer’s applicable financial statement with respect to such property, and
130 22.19 - 22.23 [SEC. 10101.(b)(1)] SEC. 56A.(c)(13)(B)(ii) to take into account any other item specified by the Secretary in order to provide that such property is accounted for in the same manner as it is accounted for under this chapter.
131 22.24 - 22.24 [SEC. 10101.(b)(1)] SEC. 56A.(c)(14) QUALIFIED WIRELESS SPECTRUM.
132 23.1 - 23.2 [SEC. 10101.(b)(1)] SEC. 56A.(c)(14)(A) IN GENERAL. Adjusted financial statement income shall be
133 23.3 - 23.8 [SEC. 10101.(b)(1)] SEC. 56A.(c)(14)(A)(i) reduced by amortization deductions allowed under section 197 with respect to qualified wireless spectrum to the extent of the amount allowed as deductions in computing taxable income for the taxable year, and
134 23.9 - 23.9 [SEC. 10101.(b)(1)] SEC. 56A.(c)(14)(A)(ii) appropriately adjusted
135 23.10 - 23.14 [SEC. 10101.(b)(1)] SEC. 56A.(c)(14)(A)(ii)(I) to disregard any amount of amortization expense that is taken into account on the taxpayer’s applicable financial statement with respect to such qualified wireless spectrum, and
136 23.15 - 23.20 [SEC. 10101.(b)(1)] SEC. 56A.(c)(14)(A)(ii)(II) to take into account any other item specified by the Secretary in order to provide that such qualified wireless spectrum is accounted for in the same manner as it is accounted for under this chapter.
137 23.21 - 23.24 [SEC. 10101.(b)(1)] SEC. 56A.(c)(14)(B) QUALIFIED WIRELESS SPECTRUM. For purposes of this paragraph, the term ‘qualified wireless spectrum’ means wireless spectrum which
138 24.1 - 24.2 [SEC. 10101.(b)(1)] SEC. 56A.(c)(14)(B)(i) is used in the trade or business of a wireless telecommunications carrier, and
139 24.3 - 24.5 [SEC. 10101.(b)(1)] SEC. 56A.(c)(14)(B)(ii) was acquired after December 31, 2007, and before the date of enactment of this section.
140 24.6 - 24.11 [SEC. 10101.(b)(1)] SEC. 56A.(c)(15) SECRETARIAL AUTHORITY TO ADJUST ITEMS. The Secretary shall issue regulations or other guidance to provide for such adjustments to adjusted financial statement income as the Secretary determines necessary to carry out the purposes of this section, including adjustments
141 24.12 - 24.13 [SEC. 10101.(b)(1)] SEC. 56A.(c)(15)(A) to prevent the omission or duplication of any item, and
142 24.14 - 24.20 [SEC. 10101.(b)(1)] SEC. 56A.(c)(15)(B) to carry out the principles of part II of subchapter C of this chapter (relating to corporate liquidations), part III of subchapter C of this chapter (relating to corporate organizations and reorganizations), and part II of subchapter K of this chapter (relating to partnership contributions and distributions).
143 24.21 - 24.22 [SEC. 10101.(b)(1)] SEC. 56A.(d) DEDUCTION FOR FINANCIAL STATEMENT NET OPERATING LOSS.
144 24.23 - 25.2 [SEC. 10101.(b)(1)] SEC. 56A.(d)(1) IN GENERAL. Adjusted financial statement income (determined after application of subsection (c) and without regard to this subsection) shall be reduced by an amount equal to the lesser of
145 25.3 - 25.5 [SEC. 10101.(b)(1)] SEC. 56A.(d)(1)(A) the aggregate amount of financial statement net operating loss carryovers to the taxable year, or
146 25.6 - 25.8 [SEC. 10101.(b)(1)] SEC. 56A.(d)(1)(B) 80 percent of adjusted financial statement income computed without regard to the deduction allowable under this subsection.
147 25.9 - 25.16 [SEC. 10101.(b)(1)] SEC. 56A.(d)(2) FINANCIAL STATEMENT NET OPERATING LOSS CARRYOVER. A financial statement net operating loss for any taxable year shall be a financial statement net operating loss carryover to each taxable year following the taxable year of the loss. The portion of such loss which shall be carried to subsequent taxable years shall be the amount of such loss remaining (if any) after the application of paragraph (1).
148 25.17 - 25.24 [SEC. 10101.(b)(1)] SEC. 56A.(d)(3) FINANCIAL STATEMENT NET OPERATING LOSS DEFINED. For purposes of this subsection, the term ‘financial statement net operating loss’ means the amount of the net loss (if any) set forth on the corporation’s applicable financial statement (determined after application of subsection (c) and without regard to this subsection) for taxable years ending after December 31, 2019.
149 26.1 - 26.6 [SEC. 10101.(b)(1)] SEC. 56A.(e) REGULATIONS AND OTHER GUIDANCE. The Secretary shall provide for such regulations and other guidance as necessary to carry out the purposes of this section, including regulations and other guidance relating to the effect of the rules of this section on partnerships with income taken into account by an applicable corporation.’’.
150 26.7 - 26.10 SEC. 10101.(b)(2) CLERICAL AMENDMENT. The table of sections for part VI of subchapter A of chapter 1 is amended by inserting after the item relating to section 56 the following new item:
151 26.11 - 26.13 SEC. 10101.(c) CORPORATE AMT FOREIGN TAX CREDIT. Section 59, as amended by this section, is amended by adding at the end the following new subsection:
152 26.14 - 26.14 [SEC. 10101.(c)] (l) CORPORATE AMT FOREIGN TAX CREDIT.
153 26.15 - 26.20 [SEC. 10101.(c)] (l)(1) IN GENERAL. For purposes of this part, if an applicable corporation chooses to have the benefits of subpart A of part III of subchapter N for any taxable year, the corporate AMT foreign tax credit for the taxable year of the applicable corporation is an amount equal to sum of
154 26.21 - 26.21 [SEC. 10101.(c)] (l)(1)(A) the lesser of
155 26.22 - 27.3 [SEC. 10101.(c)] (l)(1)(A)(i) the aggregate of the applicable corporation’s pro rata share (as determined under section 56A(c)(3)) of the amount of income, war profits, and excess profits taxes (within the meaning of section 901) imposed by any foreign country or possession of the United States which are
156 27.4 - 27.9 [SEC. 10101.(c)] (l)(1)(A)(i)(I) taken into account on the applicable financial statement of each controlled foreign corporation with respect to which the applicable corporation is a United States shareholder, and
157 27.10 - 27.12 [SEC. 10101.(c)] (l)(1)(A)(i)(II) paid or accrued (for Federal income tax purposes) by each such controlled foreign corporation, or
158 27.13 - 27.16 [SEC. 10101.(c)] (l)(1)(A)(ii) the product of the amount of the adjustment under section 56A(c)(3) and the percentage specified in section 55(b)(2)(A)(i), and
159 27.17 - 27.22 [SEC. 10101.(c)] (l)(1)(B) in the case of an applicable corporation that is a domestic corporation, the amount of income, war profits, and excess profits taxes (within the meaning of section 901) imposed by any foreign country or possession of the United States to the extent such taxes are
160 27.23 - 27.25 [SEC. 10101.(c)] (l)(1)(B)(i) taken into account on the applicable corporation’s applicable financial statement, and
161 28.1 - 28.3 [SEC. 10101.(c)] (l)(1)(B)(ii) paid or accrued (for Federal income tax purposes) by the applicable corporation.
162 28.4 - 28.12 [SEC. 10101.(c)] (l)(2) CARRYOVER OF EXCESS TAX PAID. For any taxable year for which an applicable corporation chooses to have the benefits of subpart A of part III of subchapter N, the excess of the amount described in paragraph (1)(A)(i) over the amount described in paragraph (1)(A)(ii) shall increase the amount described in paragraph (1)(A)(i) in any of the first 5 succeeding taxable years to the extent not taken into account in a prior taxable year.
163 28.13 - 28.16 [SEC. 10101.(c)] (l)(3) REGULATIONS OR OTHER GUIDANCE. The Secretary shall provide for such regulations or other guidance as is necessary to carry out the purposes of this subsection.’’.
164 28.17 - 28.18 SEC. 10101.(d) TREATMENT OF GENERAL BUSINESS CREDIT. Section 38(c)(6)(E) is amended to read as follows:
166 28.19 - 28.20 [SEC. 10101.(d)] (E) CORPORATIONS. In the case of a corporation
167 28.21 - 28.25 [SEC. 10101.(d)] (E)(i) the first sentence of paragraph (1) shall be applied by substituting ‘25 percent of the taxpayer’s net income tax as exceeds $25,000’ for ‘the greater of’ and all that follows,
168 29.1 - 29.2 [SEC. 10101.(d)] (E)(ii) paragraph (2)(A) shall be applied without regard to clause (ii)(I) thereof, and
169 29.3 - 29.5 [SEC. 10101.(d)] (E)(iii) paragraph (4)(A) shall be applied without regard to clause (ii)(I) thereof.’’.
170 29.6 - 29.7 SEC. 10101.(e) CREDIT FOR PRIOR YEAR MINIMUM TAX LIABILITY.
171 29.8 - 29.9 SEC. 10101.(e)(1) IN GENERAL. Section 53(e) is amended to read as follows:
172 29.10 - 29.11 [SEC. 10101.(e)(1)] (e) APPLICATION TO APPLICABLE CORPORATIONS. In the case of a corporation
173 29.12 - 29.16 [SEC. 10101.(e)(1)] (e)(1) subsection (b)(1) shall be applied by substituting ‘the net minimum tax for all prior taxable years beginning after 2022’ for ‘the adjusted net minimum tax imposed for all prior taxable years beginning after 1986’, and
174 29.17 - 29.19 [SEC. 10101.(e)(1)] (e)(2) the amount determined under subsection (c)(1) shall be increased by the amount of tax imposed under section 59A for the taxable year.’’.
176 29.20 - 29.21 SEC. 10101.(e)(2) CONFORMING AMENDMENTS. Section 53(d) is amended
177 29.22 - 29.24 SEC. 10101.(e)(2)(A) in paragraph (2), by striking ‘‘, except that in the case’’ and all that follows through ‘‘treated as zero’’, and
178 29.25 - 29.25 SEC. 10101.(e)(2)(B) by striking paragraph (3).
179 30.1 - 30.3 SEC. 10101.(f) EFFECTIVE DATE. The amendments made by this section shall apply to taxable years beginning after December 31, 2022.
180 30.4 - 30.5 TITLE I Subtitle A PART 2 EXCISE TAX ON REPURCHASE OF CORPORATE STOCK
181 30.6 - 30.7 TITLE I Subtitle A PART 2 SEC. 10201. EXCISE TAX ON REPURCHASE OF CORPORATE STOCK.
182 30.8 - 30.9 SEC. 10201.(a) IN GENERAL. Subtitle D is amended by inserting after chapter 36 the following new chapter:
183 30.10 - 30.11 [SEC. 10201.(a)] CHAPTER 37 REPURCHASE OF CORPORATE STOCK
184 30.12 - 30.12 [SEC. 10201.(a)] CHAPTER 37 SEC. 4501. REPURCHASE OF CORPORATE STOCK.
185 30.13 - 30.16 [SEC. 10201.(a)] SEC. 4501.(a) GENERAL RULE. There is hereby imposed on each covered corporation a tax equal to 1 percent of the fair market value of any stock of the corporation which is repurchased by such corporation during the taxable year.
186 30.17 - 30.21 [SEC. 10201.(a)] SEC. 4501.(b) COVERED CORPORATION. For purposes of this section, the term ‘covered corporation’ means any domestic corporation the stock of which is traded on an established securities market (within the meaning of section 7704(b)(1)).
187 30.22 - 30.22 [SEC. 10201.(a)] SEC. 4501.(c) REPURCHASE. For purposes of this section
188 30.23 - 30.24 [SEC. 10201.(a)] SEC. 4501.(c)(1) IN GENERAL. The term ‘repurchase’ means
189 31.1 - 31.3 [SEC. 10201.(a)] SEC. 4501.(c)(1)(A) a redemption within the meaning of section 317(b) with regard to the stock of a covered corporation, and
190 31.4 - 31.6 [SEC. 10201.(a)] SEC. 4501.(c)(1)(B) any transaction determined by the Secretary to be economically similar to a transaction described in subparagraph (A).
191 31.7 - 31.8 [SEC. 10201.(a)] SEC. 4501.(c)(2) TREATMENT OF PURCHASES BY SPECIFIED AFFILIATES.
192 31.9 - 31.15 [SEC. 10201.(a)] SEC. 4501.(c)(2)(A) IN GENERAL. The acquisition of stock of a covered corporation by a specified affiliate of such covered corporation, from a person who is not the covered corporation or a specified affiliate of such covered corporation, shall be treated as a repurchase of the stock of the covered corporation by such covered corporation.
193 31.16 - 31.18 [SEC. 10201.(a)] SEC. 4501.(c)(2)(B) SPECIFIED AFFILIATE. For purposes of this section, the term ‘specified affiliate’ means, with respect to any corporation
194 31.19 - 31.22 [SEC. 10201.(a)] SEC. 4501.(c)(2)(B)(i) any corporation more than 50 percent of the stock of which is owned (by vote or by value), directly or indirectly, by such corporation, and
195 31.23 - 32.2 [SEC. 10201.(a)] SEC. 4501.(c)(2)(B)(ii) any partnership more than 50 percent of the capital interests or profits interests of which is held, directly or indirectly, by such corporation.
196 32.3 - 32.13 [SEC. 10201.(a)] SEC. 4501.(c)(3) ADJUSTMENT. The amount taken into account under subsection (a) with respect to any stock repurchased by a covered corporation shall be reduced by the fair market value of any stock issued by the covered corporation during the taxable year, including the fair market value of any stock issued or provided to employees of such covered corporation or employees of a specified affiliate of such covered corporation during the taxable year, whether or not such stock is issued or provided in response to the exercise of an option to purchase such stock.
197 32.14 - 32.15 [SEC. 10201.(a)] SEC. 4501.(d) SPECIAL RULES FOR ACQUISITION OF STOCK OF CERTAIN FOREIGN CORPORATIONS.
198 32.16 - 32.24 [SEC. 10201.(a)] SEC. 4501.(d)(1) IN GENERAL. In the case of an acquisition of stock of an applicable foreign corporation by a specified affiliate of such corporation (other than a foreign corporation or a foreign partnership (unless such partnership has a domestic entity as a direct or indirect partner)) from a person who is not the applicable foreign corporation or a specified affiliate of such applicable foreign corporation, for purposes of this section
199 33.1 - 33.3 [SEC. 10201.(a)] SEC. 4501.(d)(1)(A) such specified affiliate shall be treated as a covered corporation with respect to such acquisition,
200 33.4 - 33.6 [SEC. 10201.(a)] SEC. 4501.(d)(1)(B) such acquisition shall be treated as a repurchase of stock of a covered corporation by such covered corporation, and
201 33.7 - 33.10 [SEC. 10201.(a)] SEC. 4501.(d)(1)(C) the adjustment under subsection (c)(3) shall be determined only with respect to stock issued or provided by such specified affiliate to employees of the specified affiliate.
202 33.11 - 33.16 [SEC. 10201.(a)] SEC. 4501.(d)(2) SURROGATE FOREIGN CORPORATIONS. In the case of a repurchase of stock of a covered surrogate foreign corporation by such covered surrogate foreign corporation, or an acquisition of stock of a covered surrogate foreign corporation by a specified affiliate of such corporation, for purposes of this section
203 33.17 - 33.20 [SEC. 10201.(a)] SEC. 4501.(d)(2)(A) the expatriated entity with respect to such covered surrogate foreign corporation shall be treated as a covered corporation with respect to such repurchase or acquisition,
204 33.21 - 33.23 [SEC. 10201.(a)] SEC. 4501.(d)(2)(B) such repurchase or acquisition shall be treated as a repurchase of stock of a covered corporation by such covered corporation, and
205 33.24 - 34.2 [SEC. 10201.(a)] SEC. 4501.(d)(2)(C) the adjustment under subsection (c)(3) shall be determined only with respect to stock issued or provided by such expatriated entity to employees of the expatriated entity.
206 34.3 - 34.4 [SEC. 10201.(a)] SEC. 4501.(d)(3) DEFINITIONS. For purposes of this subsection
207 34.5 - 34.9 [SEC. 10201.(a)] SEC. 4501.(d)(3)(A) APPLICABLE FOREIGN CORPORATION. The term ‘applicable foreign corporation’ means any foreign corporation the stock of which is traded on an established securities market (within the meaning of section 7704(b)(1)).
208 34.10 - 34.21 [SEC. 10201.(a)] SEC. 4501.(d)(3)(B) COVERED SURROGATE FOREIGN CORPORATION. The term ‘covered surrogate foreign corporation’ means any surrogate foreign corporation (as determined under section 7874(a)(2)(B) by substituting ‘September 20, 2021’ for ‘March 4, 2003’ each place it appears) the stock of which is traded on an established securities market (within the meaning of section 7704(b)(1)), but only with respect to taxable years which include any portion of the applicable period with respect to such corporation under section 7874(d)(1).
209 34.22 - 34.24 [SEC. 10201.(a)] SEC. 4501.(d)(3)(C) EXPATRIATED ENTITY. The term ‘expatriated entity’ has the meaning given such term by section 7874(a)(2)(A).
210 34.25 - 34.25 [SEC. 10201.(a)] SEC. 4501.(e) EXCEPTIONS. Subsection (a) shall not apply
211 35.1 - 35.5 [SEC. 10201.(a)] SEC. 4501.(e)(1) to the extent that the repurchase is part of a reorganization (within the meaning of section 368(a)) and no gain or loss is recognized on such repurchase by the shareholder under chapter 1 by reason of such reorganization,
212 35.6 - 35.10 [SEC. 10201.(a)] SEC. 4501.(e)(2) in any case in which the stock repurchased is, or an amount of stock equal to the value of the stock repurchased is, contributed to an employer-sponsored retirement plan, employee stock ownership plan, or similar plan,
213 35.11 - 35.13 [SEC. 10201.(a)] SEC. 4501.(e)(3) in any case in which the total value of the stock repurchased during the taxable year does not exceed $1,000,000,
214 35.14 - 35.16 [SEC. 10201.(a)] SEC. 4501.(e)(4) under regulations prescribed by the Secretary, in cases in which the repurchase is by a dealer in securities in the ordinary course of business,
215 35.17 - 35.19 [SEC. 10201.(a)] SEC. 4501.(e)(5) to repurchases by a regulated investment company (as defined in section 851) or a real estate investment trust, or
216 35.20 - 35.21 [SEC. 10201.(a)] SEC. 4501.(e)(6) to the extent that the repurchase is treated as a dividend for purposes of this title.
217 35.22 - 36.2 [SEC. 10201.(a)] SEC. 4501.(f) REGULATIONS AND GUIDANCE. The Secretary shall prescribe such regulations and other guidance as are necessary or appropriate to carry out, and to prevent the avoidance of, the purposes of this section, including regulations and other guidance
218 36.3 - 36.4 [SEC. 10201.(a)] SEC. 4501.(f)(1) to prevent the abuse of the exceptions provided by subsection (e),
219 36.5 - 36.6 [SEC. 10201.(a)] SEC. 4501.(f)(2) to address special classes of stock and preferred stock, and
220 36.7 - 36.8 [SEC. 10201.(a)] SEC. 4501.(f)(3) for the application of the rules under subsection (d).’’.
221 36.9 - 36.10 SEC. 10201.(b) TAX NOT DEDUCTIBLE. Paragraph (6) of section 275(a) is amended by inserting ‘‘37,’’ before ‘‘41’’.
222 36.11 - 36.13 SEC. 10201.(c) CLERICAL AMENDMENT. The table of chapters for subtitle D is amended by inserting after the item relating to chapter 36 the following new item:
223 36.14 - 36.17 SEC. 10201.(d) EFFECTIVE DATE. The amendments made by this section shall apply to repurchases (within the meaning of section 4501(c) of the Internal Revenue Code of 1986, as added by this section) of stock after December 31, 2022.
224 36.18 - 36.20 TITLE I Subtitle A PART 3 FUNDING THE INTERNAL REVENUE SERVICE AND IMPROVING TAXPAYER COMPLIANCE
225 36.21 - 36.25 TITLE I Subtitle A PART 3 SEC. 10301. ENHANCEMENT OF INTERNAL REVENUE SERVICE RESOURCES. IN GENERAL. The following sums are appropriated, out of any money in the Treasury not otherwise appropriated, for the fiscal year ending September 30, 2022:
226 37.1 - 37.1 SEC. 10301.(1) INTERNAL REVENUE SERVICE.
227 37.2 - 37.2 SEC. 10301.(1)(A) IN GENERAL.
228 37.3 - 37.14 SEC. 10301.(1)(A)(i) TAXPAYER SERVICES. For necessary expenses of the Internal Revenue Service to provide taxpayer services, including pre-filing assistance and education, filing and account services, taxpayer advocacy services, and other services as authorized by 5 U.S.C. 3109, at such rates as may be determined by the Commissioner, $3,181,500,000, to remain available until September 30, 2031: Provided, That these amounts shall be in addition to amounts otherwise available for such purposes.
229 37.15 - 38.8 SEC. 10301.(1)(A)(ii) ENFORCEMENT. For necessary expenses for tax enforcement activities of the Internal Revenue Service to determine and collect owed taxes, to provide legal and litigation support, to conduct criminal investigations (including investigative technology), to provide digital asset monitoring and compliance activities, to enforce criminal statutes related to violations of internal revenue laws and other financial crimes, to purchase and hire passenger motor vehicles (31 U.S.C. 1343(b)), and to provide other services as authorized by 5 U.S.C. 3109, at such rates as may be determined by the Commissioner, $45,637,400,000, to remain available until September 30, 2031: Provided, That these amounts shall be in addition to amounts otherwise available for such purposes.
230 38.9 - 39.3 SEC. 10301.(1)(A)(iii) OPERATIONS SUPPORT. For necessary expenses of the Internal Revenue Service to support taxpayer services and enforcement programs, including rent payments; facilities services; printing; postage; physical security; headquarters and other IRS-wide administration activities; research and statistics of income; telecommunications; information technology development, enhancement, operations, maintenance, and security; the hire of passenger motor vehicles (31 U.S.C. 1343(b)); the operations of the Internal Revenue Service Oversight Board; and other services as authorized by 5 U.S.C. 3109, at such rates as may be determined by the Commissioner, $25,326,400,000, to remain available until September 30, 2031: Provided, That these amounts shall be in addition to amounts otherwise available for such purposes.
231 39.4 - 39.15 SEC. 10301.(1)(A)(iv) BUSINESS SYSTEMS MODERNIZATION. For necessary expenses of the Internal Revenue Service’s business systems modernization program, including development of callback technology and other technology to provide a more personalized customer service but not including the operation and maintenance of legacy systems, $4,750,700,000, to remain available until September 30, 2031: Provided, That these amounts shall be in addition to amounts otherwise available for such purposes.
232 39.16 - 40.13 SEC. 10301.(1)(B) TASK FORCE TO DESIGN AN IRS-RUN FREE ‘‘DIRECT EFILE’’ TAX RETURN SYSTEM. For necessary expenses of the Internal Revenue Service to deliver to Congress, within nine months following the date of the enactment of this Act, a report on (I) the cost (including options for differential coverage based on taxpayer adjusted gross income and return complexity) of developing and running a free direct efile tax return system, including costs to build and administer each release, with a focus on multi-lingual and mobile-friendly features and safeguards for taxpayer data; (II) taxpayer opinions, expectations, and level of trust, based on surveys, for such a free direct efile system; and (III) the opinions of an independent third-party on the overall feasibility, approach, schedule, cost, organizational design, and Internal Revenue Service capacity to deliver such a direct efile tax return system, $15,000,000, to remain available until September 30, 2023: Provided, That these amounts shall be in addition to amounts otherwise available for such purposes.
233 40.14 - 40.25 SEC. 10301.(2) TREASURY INSPECTOR GENERAL FOR TAX ADMINISTRATION. For necessary expenses of the Treasury Inspector General for Tax Administration in carrying out the Inspector General Act of 1978, as amended, including purchase and hire of passenger motor vehicles (31 U.S.C. 1343(b)); and services authorized by 5 U.S.C. 3109, at such rates as may be determined by the Inspector General for Tax Administration, $403,000,000, to remain available until September 30, 2031: Provided, That these amounts shall be in addition to amounts otherwise available for such purposes.
234 41.1 - 41.8 SEC. 10301.(3) OFFICE OF TAX POLICY. For necessary expenses of the Office of Tax Policy of the Department of the Treasury to carry out functions related to promulgating regulations under the Internal Revenue Code of 1986, $104,533,803, to remain available until September 30, 2031: Provided, That these amounts shall be in addition to amounts otherwise available for such purposes.
235 41.9 - 41.15 SEC. 10301.(4) UNITED STATES TAX COURT. For necessary expenses of the United States Tax Court, including contract reporting and other services as authorized by 5 U.S.C. 3109; $153,000,000, to remain available until September 30, 2031: Provided, That these amounts shall be in addition to amounts otherwise available for such purposes.
236 41.16 - 41.24 SEC. 10301.(5) TREASURY DEPARTMENTAL OFFICES. For necessary expenses of the Departmental Offices of the Department of the Treasury to provide for oversight and implementation support for actions by the Internal Revenue Service to implement this Act and the amendments made by this Act, $50,000,000, to remain available until September 30, 2031: Provided, That these amounts shall be in addition to amounts otherwise available for such purposes.
237 42.1 - 42.2 TITLE I Subtitle B Prescription Drug Pricing Reform
238 42.3 - 42.4 TITLE I Subtitle B PART 1 LOWERING PRICES THROUGH DRUG PRICE NEGOTIATION
239 42.5 - 42.6 TITLE I Subtitle B PART 1 SEC. 11001. PROVIDING FOR LOWER PRICES FOR CERTAIN HIGH-PRICED SINGLE SOURCE DRUGS.
240 42.7 - 42.10 SEC. 11001.(a) PROGRAM TO LOWER PRICES FOR CERTAIN HIGHPRICED SINGLE SOURCE DRUGS. Title XI of the Social Security Act is amended by adding after section 1184 (42 U.S.C. 1320e–3) the following new part:
241 42.11 - 42.13 [SEC. 11001.(a)] PART E PRICE NEGOTIATION PROGRAM TO LOWER PRICES FOR CERTAIN HIGH-PRICED SINGLE SOURCE DRUGS
242 42.14 - 42.14 [SEC. 11001.(a)] PART E SEC. 1191. ESTABLISHMENT OF PROGRAM.
243 42.15 - 42.18 [SEC. 11001.(a)] SEC. 1191.(a) IN GENERAL. The Secretary shall establish a Drug Price Negotiation Program (in this part referred to as the ‘program’). Under the program, with respect to each price applicability period, the Secretary shall
244 42.19 - 42.20 [SEC. 11001.(a)] SEC. 1191.(a)(1) publish a list of selected drugs in accordance with section 1192;
245 42.21 - 42.23 [SEC. 11001.(a)] SEC. 1191.(a)(2) enter into agreements with manufacturers of selected drugs with respect to such period, in accordance with section 1193;
246 43.1 - 43.3 [SEC. 11001.(a)] SEC. 1191.(a)(3) negotiate and, if applicable, renegotiate maximum fair prices for such selected drugs, in accordance with section 1194;
247 43.4 - 43.6 [SEC. 11001.(a)] SEC. 1191.(a)(4) carry out the publication and administrative duties and compliance monitoring in accordance with sections 1195 and 1196.
248 43.7 - 43.8 [SEC. 11001.(a)] SEC. 1191.(b) DEFINITIONS RELATING TO TIMING. For purposes of this part:
249 43.9 - 43.11 [SEC. 11001.(a)] SEC. 1191.(b)(1) INITIAL PRICE APPLICABILITY YEAR. The term ‘initial price applicability year’ means a year (beginning with 2026).
250 43.12 - 43.18 [SEC. 11001.(a)] SEC. 1191.(b)(2) PRICE APPLICABILITY PERIOD. The term ‘price applicability period’ means, with respect to a qualifying single source drug, the period beginning with the first initial price applicability year with respect to which such drug is a selected drug and ending with the last year during which the drug is a selected drug.
251 43.19 - 43.23 [SEC. 11001.(a)] SEC. 1191.(b)(3) SELECTED DRUG PUBLICATION DATE. The term ‘selected drug publication date’ means, with respect to each initial price applicability year, February 1 of the year that begins 2 years prior to such year.
252 43.24 - 44.2 [SEC. 11001.(a)] SEC. 1191.(b)(4) NEGOTIATION PERIOD. The term ‘negotiation period’ means, with respect to an initial price applicability year with respect to a selected drug, the period
253 44.3 - 44.3 [SEC. 11001.(a)] SEC. 1191.(b)(4)(A) beginning on the sooner of
254 44.4 - 44.7 [SEC. 11001.(a)] SEC. 1191.(b)(4)(A)(i) the date on which the manufacturer of the drug and the Secretary enter into an agreement under section 1193 with respect to such drug; or
255 44.8 - 44.10 [SEC. 11001.(a)] SEC. 1191.(b)(4)(A)(ii) February 28 following the selected drug publication date with respect to such selected drug; and
256 44.11 - 44.13 [SEC. 11001.(a)] SEC. 1191.(b)(4)(B) ending on November 1 of the year that begins 2 years prior to the initial price applicability year.
257 44.14 - 44.14 [SEC. 11001.(a)] SEC. 1191.(c) OTHER DEFINITIONS. For purposes of this part:
258 44.15 - 44.17 [SEC. 11001.(a)] SEC. 1191.(c)(1) MANUFACTURER. The term ‘manufacturer’ has the meaning given that term in section 1847A(c)(6)(A).
259 44.18 - 44.20 [SEC. 11001.(a)] SEC. 1191.(c)(2) MAXIMUM FAIR PRICE ELIGIBLE INDIVIDUAL. The term ‘maximum fair price eligible individual’ means, with respect to a selected drug
260 44.21 - 45.2 [SEC. 11001.(a)] SEC. 1191.(c)(2)(A) in the case such drug is dispensed to the individual at a pharmacy, by a mail order service, or by another dispenser, an individual who is enrolled in a prescription drug plan under part D of title XVIII or an MA–PD plan under part C of such title if coverage is provided under such plan for such selected drug; and
261 45.3 - 45.10 [SEC. 11001.(a)] SEC. 1191.(c)(2)(B) in the case such drug is furnished or administered to the individual by a hospital, physician, or other provider of services or supplier, an individual who is enrolled under part B of title XVIII, including an individual who is enrolled in an MA plan under part C of such title, if payment may be made under part B for such selected drug.
262 45.11 - 45.17 [SEC. 11001.(a)] SEC. 1191.(c)(3) MAXIMUM FAIR PRICE. The term ‘maximum fair price’ means, with respect to a year during a price applicability period and with respect to a selected drug (as defined in section 1192(c)) with respect to such period, the price negotiated pursuant to section 1194, and updated pursuant to section 1195(b), as applicable, for such drug and year.
263 45.18 - 45.20 [SEC. 11001.(a)] SEC. 1191.(c)(4) REFERENCE PRODUCT. The term ‘reference product’ has the meaning given such term in section 351(i) of the Public Health Service Act.
264 45.21 - 46.4 [SEC. 11001.(a)] SEC. 1191.(c)(5) TOTAL EXPENDITURES. The term ‘total expenditures’ includes, in the case of expenditures with respect to part D of title XVIII, the total gross covered prescription drug costs (as defined in section 1860D– 15(b)(3)). The term ‘total expenditures’ excludes, in the case of expenditures with respect to part B of such title, expenditures for a drug or biological product that are bundled or packaged into the payment for another service.
265 46.5 - 46.9 [SEC. 11001.(a)] SEC. 1191.(c)(6) UNIT. The term ‘unit’ means, with respect to a drug or biological product, the lowest identifiable amount (such as a capsule or tablet, milligram of molecules, or grams) of the drug or biological product that is dispensed or furnished.
266 46.10 - 46.13 [SEC. 11001.(a)] SEC. 1191.(d) TIMING FOR INITIAL PRICE APPLICABILITY YEAR 2026. Notwithstanding the provisions of this part, in the case of initial price applicability year 2026, the following rules shall apply for purposes of implementing the program:
267 46.14 - 46.17 [SEC. 11001.(a)] SEC. 1191.(d)(1) Subsection (b)(3) shall be applied by substituting ‘September 1, 2023’ for ‘, with respect to each initial price applicability year, February 1 of the year that begins 2 years prior to such year’.
268 46.18 - 46.18 [SEC. 11001.(a)] SEC. 1191.(d)(2) Subsection (b)(4) shall be applied
269 46.19 - 46.22 [SEC. 11001.(a)] SEC. 1191.(d)(2)(A) in subparagraph (A)(ii), by substituting ‘October 1, 2023’ for ‘February 28 following the selected drug publication date with respect to such selected drug’; and
270 46.23 - 47.2 [SEC. 11001.(a)] SEC. 1191.(d)(2)(B) in subparagraph (B), by substituting ‘August 1, 2024’ for ‘November 1 of the year that begins 2 years prior to the initial price applicability year’.
271 47.3 - 47.3 [SEC. 11001.(a)] SEC. 1191.(d)(3) Section 1192 shall be applied
272 47.4 - 47.11 [SEC. 11001.(a)] SEC. 1191.(d)(3)(A) in subsection (b)(1)(A), by substituting ‘during the period beginning on June 1, 2022, and ending on May 31, 2023’ for ‘during the most recent period of 12 months prior to the selected drug publication date (but ending not later than October 31 of the year prior to the year of such drug publication date), with respect to such year, for which data are available’; and
273 47.12 - 47.20 [SEC. 11001.(a)] SEC. 1191.(d)(3)(B) in subsection (d)(1)(A), by substituting ‘during the period beginning on June 1, 2022, and ending on May 31, 2023’ for ‘during the most recent period for which data are available of at least 12 months prior to the selected drug publication date (but ending no later than October 31 of the year prior to the year of such drug publication date), with respect to such year’.
274 47.21 - 47.24 [SEC. 11001.(a)] SEC. 1191.(d)(4) Section 1193(a) shall be applied by substituting ‘October 1, 2023’ for ‘February 28 following the selected drug publication date with respect to such selected drug’.
275 47.25 - 47.25 [SEC. 11001.(a)] SEC. 1191.(d)(5) Section 1194(b)(2) shall be applied
276 48.1 - 48.4 [SEC. 11001.(a)] SEC. 1191.(d)(5)(A) in subparagraph (A), by substituting ‘October 2, 2023’ for ‘March 1 of the year of the selected drug publication date, with respect to the selected drug’;
277 48.5 - 48.7 [SEC. 11001.(a)] SEC. 1191.(d)(5)(B) in subparagraph (B), by substituting ‘February 1, 2024’ for ‘the June 1 following the selected drug publication date’; and
278 48.8 - 48.11 [SEC. 11001.(a)] SEC. 1191.(d)(5)(C) in subparagraph (E), by substituting ‘August 1, 2024’ for ‘the first day of November following the selected drug publication date, with respect to the initial price applicability year ’.
279 48.12 - 48.15 [SEC. 11001.(a)] SEC. 1191.(d)(6) Section 1195(a)(1) shall be applied by substituting ‘September 1, 2024’ for ‘November 30 of the year that is 2 years prior to such initial price applicability year’.
280 48.16 - 48.17 [SEC. 11001.(a)] PART E SEC. 1192. SELECTION OF NEGOTIATION-ELIGIBLE DRUGS AS SELECTED DRUGS.
281 48.18 - 48.21 [SEC. 11001.(a)] SEC. 1192.(a) IN GENERAL. Not later than the selected drug publication date with respect to an initial price applicability year, in accordance with subsection (b), the Secretary shall select and publish a list of
282 48.22 - 49.3 [SEC. 11001.(a)] SEC. 1192.(a)(1) with respect to the initial price applicability year 2026, 10 negotiation-eligible drugs described in subparagraph (A) of subsection (d)(1), but not subparagraph (B) of such subsection, with respect to such year (or, all (if such number is less than 10) such negotiation-eligible drugs with respect to such year);
283 49.4 - 49.10 [SEC. 11001.(a)] SEC. 1192.(a)(2) with respect to the initial price applicability year 2027, 15 negotiation-eligible drugs described in subparagraph (A) of subsection (d)(1), but not subparagraph (B) of such subsection, with respect to such year (or, all (if such number is less than 15) such negotiation-eligible drugs with respect to such year);
284 49.11 - 49.16 [SEC. 11001.(a)] SEC. 1192.(a)(3) with respect to the initial price applicability year 2028, 15 negotiation-eligible drugs described in subparagraph (A) or (B) of subsection (d)(1) with respect to such year (or, all (if such number is less than 15) such negotiation-eligible drugs with respect to such year); and
286 49.17 - 50.4 [SEC. 11001.(a)] SEC. 1192.(a)(4) with respect to the initial price applicability year 2029 or a subsequent year, 20 negotiationeligible drugs described in subparagraph (A) or (B) of subsection (d)(1), with respect to such year (or, all (if such number is less than 20) such negotiation-eligible drugs with respect to such year). Subject to subsection (c)(2) and section 1194(f)(5), each drug published on the list pursuant to the previous sentence shall be subject to the negotiation process under section 1194 for the negotiation period with respect to such initial price applicability year (and the renegotiation process under such section as applicable for any subsequent year during the applicable price applicability period).
287 50.5 - 50.5 [SEC. 11001.(a)] SEC. 1192.(b) SELECTION OF DRUGS.
288 50.6 - 50.9 [SEC. 11001.(a)] SEC. 1192.(b)(1) IN GENERAL. In carrying out subsection (a), subject to paragraph (2), the Secretary shall, with respect to an initial price applicability year, do the following:
290 50.10 - 50.20 [SEC. 11001.(a)] SEC. 1192.(b)(1)(A) Rank negotiation-eligible drugs described in subsection (d)(1) according to the total expenditures for such drugs under parts B and D of title XVIII, as determined by the Secretary, during the most recent period of 12 months prior to the selected drug publication date (but ending not later than October 31 of the year prior to the year of such drug publication date), with respect to such year, for which data are available, with the negotiation-eligible drugs with the highest total expenditures being ranked the highest.
291 50.21 - 50.23 [SEC. 11001.(a)] SEC. 1192.(b)(1)(B) Select from such ranked drugs with respect to such year the negotiation-eligible drugs with the highest such rankings.
292 50.24 - 51.9 [SEC. 11001.(a)] SEC. 1192.(b)(2) HIGH SPEND PART D DRUGS FOR 2026 AND 2027. With respect to the initial price applicability year 2026 and with respect to the initial price applicability year 2027, the Secretary shall apply paragraph (1) as if the reference to ‘negotiation-eligible drugs described in subsection (d)(1)’ were a reference to ‘negotiation-eligible drugs described in subsection (d)(1)(A)’ and as if the reference to ‘total expenditures for such drugs under parts B and D of title XVIII’ were a reference to ‘total expenditures for such drugs under part D of title XVIII’.
294 51.10 - 51.10 [SEC. 11001.(a)] SEC. 1192.(c) SELECTED DRUG.
295 51.11 - 51.20 [SEC. 11001.(a)] SEC. 1192.(c)(1) IN GENERAL. For purposes of this part, in accordance with subsection (e)(2) and subject to paragraph (2), each negotiation-eligible drug included on the list published under subsection (a) with respect to an initial price applicability year shall be referred to as a ‘selected drug’ with respect to such year and each subsequent year beginning before the first year that begins at least 9 months after the date on which the Secretary determines at least one drug or biological product
296 51.21 - 51.22 [SEC. 11001.(a)] SEC. 1192.(c)(1)(A) is approved or licensed (as applicable)
297 51.23 - 51.25 [SEC. 11001.(a)] SEC. 1192.(c)(1)(A)(i) under section 505(j) of the Federal Food, Drug, and Cosmetic Act using such drug as the listed drug; or
298 52.1 - 52.3 [SEC. 11001.(a)] SEC. 1192.(c)(1)(A)(ii) under section 351(k) of the Public Health Service Act using such drug as the reference product; and
299 52.4 - 52.5 [SEC. 11001.(a)] SEC. 1192.(c)(1)(B) is marketed pursuant to such approval or licensure.
300 52.6 - 52.7 [SEC. 11001.(a)] SEC. 1192.(c)(2) CLARIFICATION. A negotiation-eligible drug
301 52.8 - 52.10 [SEC. 11001.(a)] SEC. 1192.(c)(2)(A) that is included on the list published under subsection (a) with respect to an initial price applicability year; and
302 52.11 - 52.21 [SEC. 11001.(a)] SEC. 1192.(c)(2)(B) for which the Secretary makes a determination described in paragraph (1) before or during the negotiation period with respect to such initial price applicability year; shall not be subject to the negotiation process under section 1194 with respect to such negotiation period and shall continue to be considered a selected drug under this part with respect to the number of negotiation-eligible drugs published on the list under subsection (a) with respect to such initial price applicability year.
303 52.22 - 52.22 [SEC. 11001.(a)] SEC. 1192.(d) NEGOTIATION-ELIGIBLE DRUG.
304 52.23 - 53.6 [SEC. 11001.(a)] SEC. 1192.(d)(1) IN GENERAL. For purposes of this part, subject to paragraph (2), the term ‘negotiation-eligible drug’ means, with respect to the selected drug publication date with respect to an initial price applicability year, a qualifying single source drug, as defined in subsection (e), that is described in either of the following subparagraphs (or, with respect to the initial price applicability year 2026 or 2027, that is described in subparagraph (A)):
305 53.7 - 53.17 [SEC. 11001.(a)] SEC. 1192.(d)(1)(A) PART D HIGH SPEND DRUGS. The qualifying single source drug is, determined in accordance with subsection (e)(2), among the 50 qualifying single source drugs with the highest total expenditures under part D of title XVIII, as determined by the Secretary in accordance with paragraph (3), during the most recent 12month period for which data are available prior to such selected drug publication date (but ending no later than October 31 of the year prior to the year of such drug publication date).
306 53.18 - 53.25 [SEC. 11001.(a)] SEC. 1192.(d)(1)(B) PART B HIGH SPEND DRUGS. The qualifying single source drug is, determined in accordance with subsection (e)(2), among the 50 qualifying single source drugs with the highest total expenditures under part B of title XVIII, as determined by the Secretary in accordance with paragraph (3), during such most recent 12month period, as described in subparagraph (A).
307 54.1 - 54.1 [SEC. 11001.(a)] SEC. 1192.(d)(2) EXCEPTION FOR SMALL BIOTECH DRUGS.
308 54.2 - 54.7 [SEC. 11001.(a)] SEC. 1192.(d)(2)(A) IN GENERAL. Subject to subparagraph (C), the term ‘negotiation-eligible drug’ shall not include, with respect to the initial price applicability years 2026, 2027, and 2028, a qualifying single source drug that meets either of the following:
309 54.8 - 54.12 [SEC. 11001.(a)] SEC. 1192.(d)(2)(A)(i) PART D DRUGS. The total expenditures for the qualifying single source drug under part D of title XVIII, as determined by the Secretary in accordance with paragraph (3)(B), during 2021
310 54.13 - 54.18 [SEC. 11001.(a)] SEC. 1192.(d)(2)(A)(i)(I) are equal to or less than 1 percent of the total expenditures under such part D, as so determined, for all covered part D drugs (as defined in section 1860D–2(e)) during such year; and
311 54.19 - 54.25 [SEC. 11001.(a)] SEC. 1192.(d)(2)(A)(i)(II) are equal to at least 80 percent of the total expenditures under such part D, as so determined, for all covered part D drugs for which the manufacturer of the drug has an agreement in effect under section 1860D– 14A during such year.
312 55.1 - 55.5 [SEC. 11001.(a)] SEC. 1192.(d)(2)(A)(ii) PART B DRUGS. The total expenditures for the qualifying single source drug under part B of title XVIII, as determined by the Secretary in accordance with paragraph (3)(B), during 2021
313 55.6 - 55.11 [SEC. 11001.(a)] SEC. 1192.(d)(2)(A)(ii)(I) are equal to or less than 1 percent of the total expenditures under such part B, as so determined, for all qualifying single source drugs for which payment may be made under such part B during such year; and
314 55.12 - 55.18 [SEC. 11001.(a)] SEC. 1192.(d)(2)(A)(ii)(II) are equal to at least 80 percent of the total expenditures under such part B, as so determined, for all qualifying single source drugs of the manufacturer for which payment may be made under such part B during such year.
315 55.19 - 55.20 [SEC. 11001.(a)] SEC. 1192.(d)(2)(B) CLARIFICATIONS RELATING TO MANUFACTURERS.
316 55.21 - 56.2 [SEC. 11001.(a)] SEC. 1192.(d)(2)(B)(i) 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 paragraph.
317 56.3 - 56.14 [SEC. 11001.(a)] SEC. 1192.(d)(2)(B)(ii) LIMITATION. A drug shall not be considered to be a qualifying single source drug described in clause (i) or (ii) of subparagraph (A) if the manufacturer of such drug is acquired after 2021 by another manufacturer that does not meet the definition of a specified manufacturer under section 1860D–14C(g)(4)(B)(ii), effective at the beginning of the plan year immediately following such acquisition or, in the case of an acquisition before 2025, effective January 1, 2025.
318 56.15 - 56.20 [SEC. 11001.(a)] SEC. 1192.(d)(2)(C) DRUGS NOT INCLUDED AS SMALL BIOTECH DRUGS. A new formulation, such as an extended release formulation, of a qualifying single source drug shall not be considered a qualifying single source drug described in subparagraph (A).
319 56.21 - 56.21 [SEC. 11001.(a)] SEC. 1192.(d)(3) CLARIFICATIONS AND DETERMINATIONS.
320 56.22 - 56.25 [SEC. 11001.(a)] SEC. 1192.(d)(3)(A) PREVIOUSLY SELECTED DRUGS AND SMALL BIOTECH DRUGS EXCLUDED. In applying subparagraphs (A) and (B) of paragraph (1), the Secretary shall not consider or count
322 57.1 - 57.2 [SEC. 11001.(a)] SEC. 1192.(d)(3)(A)(i) drugs that are already selected drugs; and
323 57.3 - 57.6 [SEC. 11001.(a)] SEC. 1192.(d)(3)(A)(ii) for initial price applicability years 2026, 2027, and 2028, qualifying single source drugs described in paragraph (2)(A).
325 57.7 - 57.15 [SEC. 11001.(a)] SEC. 1192.(d)(3)(B) USE OF DATA. In determining whether a qualifying single source drug satisfies any of the criteria described in paragraph (1) or (2), the Secretary shall use data that is aggregated across dosage forms and strengths of the drug, including new formulations of the drug, such as an extended release formulation, and not based on the specific formulation or package size or package type of the drug.
327 57.16 - 57.16 [SEC. 11001.(a)] SEC. 1192.(e) QUALIFYING SINGLE SOURCE DRUG.
328 57.17 - 57.24 [SEC. 11001.(a)] SEC. 1192.(e)(1) IN GENERAL. For purposes of this part, the term ‘qualifying single source drug’ means, with respect to an initial price applicability year, subject to paragraphs (2) and (3), a covered part D drug (as defined in section 1860D–2(e)) that is described in any of the following or a drug or biological product for which payment may be made under part B of title XVIII that is described in any of the following:
329 57.25 - 57.25 [SEC. 11001.(a)] SEC. 1192.(e)(1)(A) DRUG PRODUCTS. A drug
330 58.1 - 58.4 [SEC. 11001.(a)] SEC. 1192.(e)(1)(A)(i) that is approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act and is marketed pursuant to such approval;
331 58.5 - 58.9 [SEC. 11001.(a)] SEC. 1192.(e)(1)(A)(ii) for which, as of the selected drug publication date with respect to such initial price applicability year, at least 7 years will have elapsed since the date of such approval; and
332 58.10 - 58.12 [SEC. 11001.(a)] SEC. 1192.(e)(1)(A)(iii) that is not the listed drug for any drug that is approved and marketed under section 505(j) of such Act.
333 58.13 - 58.14 [SEC. 11001.(a)] SEC. 1192.(e)(1)(B) BIOLOGICAL PRODUCTS. A biological product
334 58.15 - 58.17 [SEC. 11001.(a)] SEC. 1192.(e)(1)(B)(i) that is licensed under section 351(a) of the Public Health Service Act and is marketed under section 351 of such Act;
335 58.18 - 58.22 [SEC. 11001.(a)] SEC. 1192.(e)(1)(B)(ii) for which, as of the selected drug publication date with respect to such initial price applicability year, at least 11 years will have elapsed since the date of such licensure; and
336 58.23 - 59.2 [SEC. 11001.(a)] SEC. 1192.(e)(1)(B)(iii) that is not the reference product for any biological product that is licensed and marketed under section 351(k) of such Act.
337 59.3 - 59.4 [SEC. 11001.(a)] SEC. 1192.(e)(2) TREATMENT OF AUTHORIZED GENERIC DRUGS.
338 59.5 - 59.15 [SEC. 11001.(a)] SEC. 1192.(e)(2)(A) IN GENERAL. In the case of a qualifying single source drug described in subparagraph (A) or (B) of paragraph (1) that is the listed drug (as such term is used in section 505(j) of the Federal Food, Drug, and Cosmetic Act) or a product described in clause (ii) of subparagraph (B), with respect to an authorized generic drug, in applying the provisions of this part, such authorized generic drug and such listed drug or such product shall be treated as the same qualifying single source drug.
339 59.16 - 59.18 [SEC. 11001.(a)] SEC. 1192.(e)(2)(B) AUTHORIZED GENERIC DRUG DEFINED. For purposes of this paragraph, the term ‘authorized generic drug’ means
340 59.19 - 59.22 [SEC. 11001.(a)] SEC. 1192.(e)(2)(B)(i) in the case of a drug, an authorized generic drug (as such term is defined in section 505(t)(3) of the Federal Food, Drug, and Cosmetic Act); and
341 59.23 - 59.24 [SEC. 11001.(a)] SEC. 1192.(e)(2)(B)(ii) in the case of a biological product, a product that
342 60.1 - 60.2 [SEC. 11001.(a)] SEC. 1192.(e)(2)(B)(ii)(I) has been licensed under section 351(a) of such Act; and
343 60.3 - 60.11 [SEC. 11001.(a)] SEC. 1192.(e)(2)(B)(ii)(II) is marketed, sold, or distributed directly or indirectly to retail class of trade under a different labeling, packaging (other than repackaging as the reference product in blister packs, unit doses, or similar packaging for use in institutions), product code, labeler code, trade name, or trade mark than the reference product.
344 60.12 - 60.14 [SEC. 11001.(a)] SEC. 1192.(e)(3) EXCLUSIONS. In this part, the term ‘qualifying single source drug’ does not include any of the following:
345 60.15 - 60.20 [SEC. 11001.(a)] SEC. 1192.(e)(3)(A) CERTAIN ORPHAN DRUGS. A drug that is designated as a drug for only one rare disease or condition under section 526 of the Federal Food, Drug, and Cosmetic Act and for which the only approved indication (or indications) is for such disease or condition.
346 60.21 - 60.25 [SEC. 11001.(a)] SEC. 1192.(e)(3)(B) LOW SPEND MEDICARE DRUGS. A drug or biological product with respect to which the total expenditures under parts B and D of title XVIII, as determined by the Secretary in accordance with subsection (d)(3)(B)
347 61.1 - 61.4 [SEC. 11001.(a)] SEC. 1192.(e)(3)(B)(i) with respect to initial price applicability year 2026, is less than, during the period beginning on June 1, 2022, and ending on May 31, 2023, $200,000,000;
348 61.5 - 61.15 [SEC. 11001.(a)] SEC. 1192.(e)(3)(B)(ii) with respect to initial price applicability year 2027, is less than, during the most recent 12-month period applicable under subparagraphs (A) and (B) of subsection (d)(1) for such year, the dollar amount specified in clause (i) increased by the annual percentage increase in the consumer price index for all urban consumers (all items; United States city average) for the period beginning on June 1, 2023, and ending on September 30, 2024; or
349 61.16 - 62.3 [SEC. 11001.(a)] SEC. 1192.(e)(3)(B)(iii) with respect to a subsequent initial price applicability year, is less than, during the most recent 12-month period applicable under subparagraphs (A) and (B) of subsection (d)(1) for such year, the dollar amount specified in this subparagraph for the previous initial price applicability year increased by the annual percentage increase in such consumer price index for the 12month period ending on September 30 of the year prior to the year of the selected drug publication date with respect to such subsequent initial price applicability year.
350 62.4 - 62.6 [SEC. 11001.(a)] SEC. 1192.(e)(3)(C) PLASMA-DERIVED PRODUCTS. A biological product that is derived from human whole blood or plasma.
351 62.7 - 62.7 [SEC. 11001.(a)] PART E SEC. 1193. MANUFACTURER AGREEMENTS.
352 62.8 - 62.13 [SEC. 11001.(a)] SEC. 1193.(a) IN GENERAL. For purposes of section 1191(a)(2), the Secretary shall enter into agreements with manufacturers of selected drugs with respect to a price applicability period, by not later than February 28 following the selected drug publication date with respect to such selected drug, under which
353 62.14 - 62.21 [SEC. 11001.(a)] SEC. 1193.(a)(1) during the negotiation period for the initial price applicability year for the selected drug, the Secretary and the manufacturer, in accordance with section 1194, negotiate to determine (and, by not later than the last date of such period, agree to) a maximum fair price for such selected drug of the manufacturer in order for the manufacturer to provide access to such price
354 62.22 - 63.5 [SEC. 11001.(a)] SEC. 1193.(a)(1)(A) to maximum fair price eligible individuals who with respect to such drug are described in subparagraph (A) of section 1191(c)(2) and are dispensed such drug (and to pharmacies, mail order services, and other dispensers, with respect to such maximum fair price eligible individuals who are dispensed such drugs) during, subject to paragraph (2), the price applicability period; and
355 63.6 - 63.12 [SEC. 11001.(a)] SEC. 1193.(a)(1)(B) to hospitals, physicians, and other providers of services and suppliers with respect to maximum fair price eligible individuals who with respect to such drug are described in subparagraph (B) of such section and are furnished or administered such drug during, subject to paragraph (2), the price applicability period;
356 63.13 - 63.18 [SEC. 11001.(a)] SEC. 1193.(a)(2) the Secretary and the manufacturer shall, in accordance with section 1194, renegotiate (and, by not later than the last date of the period of renegotiation, agree to) the maximum fair price for such drug, in order for the manufacturer to provide access to such maximum fair price (as so renegotiated)
357 63.19 - 64.3 [SEC. 11001.(a)] SEC. 1193.(a)(2)(A) to maximum fair price eligible individuals who with respect to such drug are described in subparagraph (A) of section 1191(c)(2) and are dispensed such drug (and to pharmacies, mail order services, and other dispensers, with respect to such maximum fair price eligible individuals who are dispensed such drugs) during any year during the price applicability period (beginning after such renegotiation) with respect to such selected drug; and
358 64.4 - 64.10 [SEC. 11001.(a)] SEC. 1193.(a)(2)(B) to hospitals, physicians, and other providers of services and suppliers with respect to maximum fair price eligible individuals who with respect to such drug are described in subparagraph (B) of such section and are furnished or administered such drug during any year described in subparagraph (A);
359 64.11 - 64.14 [SEC. 11001.(a)] SEC. 1193.(a)(3) subject to subsection (d), access to the maximum fair price (including as renegotiated pursuant to paragraph (2)), with respect to such a selected drug, shall be provided by the manufacturer to
360 64.15 - 64.25 [SEC. 11001.(a)] SEC. 1193.(a)(3)(A) maximum fair price eligible individuals, who with respect to such drug are described in subparagraph (A) of section 1191(c)(2), at the pharmacy, mail order service, or other dispenser at the point-of-sale of such drug (and shall be provided by the manufacturer to the pharmacy, mail order service, or other dispenser, with respect to such maximum fair price eligible individuals who are dispensed such drugs), as described in paragraph (1)(A) or (2)(A), as applicable; and
361 65.1 - 65.7 [SEC. 11001.(a)] SEC. 1193.(a)(3)(B) hospitals, physicians, and other providers of services and suppliers with respect to maximum fair price eligible individuals who with respect to such drug are described in subparagraph (B) of such section and are furnished or administered such drug, as described in paragraph (1)(B) or (2)(B), as applicable;
362 65.8 - 65.13 [SEC. 11001.(a)] SEC. 1193.(a)(4) the manufacturer submits to the Secretary, in a form and manner specified by the Secretary, for the negotiation period for the price applicability period (and, if applicable, before any period of renegotiation pursuant to section 1194(f)) with respect to such drug
363 65.14 - 65.17 [SEC. 11001.(a)] SEC. 1193.(a)(4)(A) information on the non-Federal average manufacturer price (as defined in section 8126(h)(5) of title 38, United States Code) for the drug for the applicable year or period; and
364 65.18 - 65.20 [SEC. 11001.(a)] SEC. 1193.(a)(4)(B) information that the Secretary requires to carry out the negotiation (or renegotiation process) under this part; and
365 65.21 - 65.24 [SEC. 11001.(a)] SEC. 1193.(a)(5) the manufacturer complies with requirements determined by the Secretary to be necessary for purposes of administering the program and monitoring compliance with the program.
366 66.1 - 66.5 [SEC. 11001.(a)] SEC. 1193.(b) AGREEMENT IN EFFECT UNTIL DRUG IS NO LONGER A SELECTED DRUG. An agreement entered into under this section shall be effective, with respect to a selected drug, until such drug is no longer considered a selected drug under section 1192(c).
367 66.6 - 66.12 [SEC. 11001.(a)] SEC. 1193.(c) CONFIDENTIALITY OF INFORMATION. Information submitted to the Secretary under this part by a manufacturer of a selected drug that is proprietary information of such manufacturer (as determined by the Secretary) shall be used only by the Secretary or disclosed to and used by the Comptroller General of the United States for purposes of carrying out this part.
368 66.13 - 66.15 [SEC. 11001.(a)] SEC. 1193.(d) NONDUPLICATION WITH 340B CEILING PRICE. Under an agreement entered into under this section, the manufacturer of a selected drug
369 66.16 - 67.2 [SEC. 11001.(a)] SEC. 1193.(d)(1) shall not be required to provide access to the maximum fair price under subsection (a)(3), with respect to such selected drug and maximum fair price eligible individuals who are eligible to be furnished, administered, or dispensed such selected drug at a covered entity described in section 340B(a)(4) of the Public Health Service Act, to such covered entity if such selected drug is subject to an agreement described in section 340B(a)(1) of such Act and the ceiling price (defined in section 340B(a)(1) of such Act) is lower than the maximum fair price for such selected drug; and
370 67.3 - 67.10 [SEC. 11001.(a)] SEC. 1193.(d)(2) shall be required to provide access to the maximum fair price to such covered entity with respect to maximum fair price eligible individuals who are eligible to be furnished, administered, or dispensed such selected drug at such entity at such ceiling price in a nonduplicated amount to the ceiling price if such maximum fair price is below the ceiling price for such selected drug.
371 67.11 - 67.11 [SEC. 11001.(a)] PART E SEC. 1194. NEGOTIATION AND RENEGOTIATION PROCESS.
372 67.12 - 67.17 [SEC. 11001.(a)] SEC. 1194.(a) IN GENERAL. For purposes of this part, under an agreement under section 1193 between the Secretary and a manufacturer of a selected drug (or selected drugs), with respect to the period for which such agreement is in effect and in accordance with subsections (b), (c), and (d), the Secretary and the manufacturer
373 67.18 - 67.21 [SEC. 11001.(a)] SEC. 1194.(a)(1) shall during the negotiation period with respect to such drug, in accordance with this section, negotiate a maximum fair price for such drug for the purpose described in section 1193(a)(1); and
374 67.22 - 68.2 [SEC. 11001.(a)] SEC. 1194.(a)(2) renegotiate, in accordance with the process specified pursuant to subsection (f), such maximum fair price for such drug for the purpose described in section 1193(a)(2) if such drug is a renegotiation-eligible drug under such subsection.
375 68.3 - 68.3 [SEC. 11001.(a)] SEC. 1194.(b) NEGOTIATION PROCESS REQUIREMENTS.
376 68.4 - 68.8 [SEC. 11001.(a)] SEC. 1194.(b)(1) METHODOLOGY AND PROCESS. The Secretary shall develop and use a consistent methodology and process, in accordance with paragraph (2), for negotiations under subsection (a) that aims to achieve the lowest maximum fair price for each selected drug.
377 68.9 - 68.14 [SEC. 11001.(a)] SEC. 1194.(b)(2) SPECIFIC ELEMENTS OF NEGOTIATION PROCESS. As part of the negotiation process under this section, with respect to a selected drug and the negotiation period with respect to the initial price applicability year with respect to such drug, the following shall apply:
378 68.15 - 68.21 [SEC. 11001.(a)] SEC. 1194.(b)(2)(A) SUBMISSION OF INFORMATION. Not later than March 1 of the year of the selected drug publication date, with respect to the selected drug, the manufacturer of the drug shall submit to the Secretary, in accordance with section 1193(a)(4), the information described in such section.
379 68.22 - 69.5 [SEC. 11001.(a)] SEC. 1194.(b)(2)(B) INITIAL OFFER BY SECRETARY. Not later than the June 1 following the selected drug publication date, the Secretary shall provide the manufacturer of the selected drug with a written initial offer that contains the Secretary’s proposal for the maximum fair price of the drug and a concise justification based on the factors described in section 1194(e) that were used in developing such offer.
380 69.6 - 69.6 [SEC. 11001.(a)] SEC. 1194.(b)(2)(C) RESPONSE TO INITIAL OFFER.
381 69.7 - 69.11 [SEC. 11001.(a)] SEC. 1194.(b)(2)(C)(i) IN GENERAL. Not later than 30 days after the date of receipt of an initial offer under subparagraph (B), the manufacturer shall either accept such offer or propose a counteroffer to such offer.
382 69.12 - 69.14 [SEC. 11001.(a)] SEC. 1194.(b)(2)(C)(ii) COUNTEROFFER REQUIREMENTS. If a manufacturer proposes a counteroffer, such counteroffer
383 69.15 - 69.15 [SEC. 11001.(a)] SEC. 1194.(b)(2)(C)(ii)(I) shall be in writing; and
384 69.16 - 69.17 [SEC. 11001.(a)] SEC. 1194.(b)(2)(C)(ii)(II) shall be justified based on the factors described in subsection (e).
385 69.18 - 69.21 [SEC. 11001.(a)] SEC. 1194.(b)(2)(D) RESPONSE TO COUNTEROFFER. After receiving a counteroffer under subparagraph (C), the Secretary shall respond in writing to such counteroffer.
386 69.22 - 70.2 [SEC. 11001.(a)] SEC. 1194.(b)(2)(E) DEADLINE. All negotiations between the Secretary and the manufacturer of the selected drug shall end prior to the first day of November following the selected drug publication date, with respect to the initial price applicability year.
387 70.3 - 70.12 [SEC. 11001.(a)] SEC. 1194.(b)(2)(F) LIMITATIONS ON OFFER AMOUNT. In negotiating the maximum fair price of a selected drug, with respect to the initial price applicability year for the selected drug, and, as applicable, in renegotiating the maximum fair price for such drug, with respect to a subsequent year during the price applicability period for such drug, the Secretary shall not offer (or agree to a counteroffer for) a maximum fair price for the selected drug that
388 70.13 - 70.15 [SEC. 11001.(a)] SEC. 1194.(b)(2)(F)(i) exceeds the ceiling determined under subsection (c) for the selected drug and year; or
389 70.16 - 70.18 [SEC. 11001.(a)] SEC. 1194.(b)(2)(F)(ii) as applicable, is less than the floor determined under subsection (d) for the selected drug and year.
390 70.19 - 70.19 [SEC. 11001.(a)] SEC. 1194.(c) CEILING FOR MAXIMUM FAIR PRICE.
391 70.20 - 70.20 [SEC. 11001.(a)] SEC. 1194.(c)(1) GENERAL CEILING.
392 70.21 - 71.2 [SEC. 11001.(a)] SEC. 1194.(c)(1)(A) IN GENERAL. The maximum fair price negotiated under this section for a selected drug, with respect to the first initial price applicability year of the price applicability period with respect to such drug, shall not exceed the lower of the amount under subparagraph (B) or the amount under subparagraph (C).
393 71.3 - 71.4 [SEC. 11001.(a)] SEC. 1194.(c)(1)(B) SUBPARAGRAPH (B) AMOUNT. An amount equal to the following:
394 71.5 - 71.10 [SEC. 11001.(a)] SEC. 1194.(c)(1)(B)(i) COVERED PART D DRUG. In the case of a covered part D drug (as defined in section 1860D–2(e)), the sum of the plan specific enrollment weighted amounts for each prescription drug plan or MA–PD plan (as determined under paragraph (2)).
395 71.11 - 71.20 [SEC. 11001.(a)] SEC. 1194.(c)(1)(B)(ii) PART B DRUG OR BIOLOGICAL. In the case of a drug or biological product for which payment may be made under part B of title XVIII, the payment amount under section 1847A(b)(4) for the drug or biological product for the year prior to the year of the selected drug publication date with respect to the initial price applicability year for the drug or biological product.
396 71.21 - 71.24 [SEC. 11001.(a)] SEC. 1194.(c)(1)(C) SUBPARAGRAPH (C) AMOUNT. An amount equal to the applicable percent described in paragraph (3), with respect to such drug, of the following:
397 72.1 - 72.19 [SEC. 11001.(a)] SEC. 1194.(c)(1)(C)(i) INITIAL PRICE APPLICABILITY YEAR 2026. In the case of a selected drug with respect to which such initial price applicability year is 2026, the average nonFederal average manufacturer price for such drug for 2021 (or, in the case that there is not an average non-Federal average manufacturer price available for such drug for 2021, for the first full year following the market entry for such drug), increased by the percentage increase in the consumer price index for all urban consumers (all items; United States city average) from September 2021 (or December of such first full year following the market entry), as applicable, to September of the year prior to the year of the selected drug publication date with respect to such initial price applicability year.
398 72.20 - 72.24 [SEC. 11001.(a)] SEC. 1194.(c)(1)(C)(ii) INITIAL PRICE APPLICABILITY YEAR 2027 AND SUBSEQUENT YEARS. In the case of a selected drug with respect to which such initial price applicability year is 2027 or a subsequent year, the lower of
399 73.1 - 73.17 [SEC. 11001.(a)] SEC. 1194.(c)(1)(C)(ii)(I) the average non-Federal average manufacturer price for such drug for 2021 (or, in the case that there is not an average non-Federal average manufacturer price available for such drug for 2021, for the first full year following the market entry for such drug), increased by the percentage increase in the consumer price index for all urban consumers (all items; United States city average) from September 2021 (or December of such first full year following the market entry), as applicable, to September of the year prior to the year of the selected drug publication date with respect to such initial price applicability year; or
400 73.18 - 73.22 [SEC. 11001.(a)] SEC. 1194.(c)(1)(C)(ii)(II) the average non-Federal average manufacturer price for such drug for the year prior to the selected drug publication date with respect to such initial price applicability year.
401 73.23 - 74.3 [SEC. 11001.(a)] SEC. 1194.(c)(2) PLAN SPECIFIC ENROLLMENT WEIGHTED AMOUNT. For purposes of paragraph (1)(B)(i), the plan specific enrollment weighted amount for a prescription drug plan or an MA–PD plan with respect to a covered Part D drug is an amount equal to the product of
402 74.4 - 74.9 [SEC. 11001.(a)] SEC. 1194.(c)(2)(A) the negotiated price of the drug under such plan under part D of title XVIII, net of all price concessions received by such plan or pharmacy benefit managers on behalf of such plan, for the most recent year for which data is available; and
403 74.10 - 74.10 [SEC. 11001.(a)] SEC. 1194.(c)(2)(B) a fraction
404 74.11 - 74.13 [SEC. 11001.(a)] SEC. 1194.(c)(2)(B)(i) the numerator of which is the total number of individuals enrolled in such plan in such year; and
405 74.14 - 74.17 [SEC. 11001.(a)] SEC. 1194.(c)(2)(B)(ii) the denominator of which is the total number of individuals enrolled in a prescription drug plan or an MA–PD plan in such year.
406 74.18 - 74.20 [SEC. 11001.(a)] SEC. 1194.(c)(3) APPLICABLE PERCENT DESCRIBED. For purposes of this subsection, the applicable percent described in this paragraph is the following:
407 74.21 - 74.24 [SEC. 11001.(a)] SEC. 1194.(c)(3)(A) SHORT-MONOPOLY DRUGS AND VACCINES. With respect to a selected drug (other than an extended-monopoly drug and a long-monopoly drug), 75 percent.
408 75.1 - 75.3 [SEC. 11001.(a)] SEC. 1194.(c)(3)(B) EXTENDED-MONOPOLY DRUGS. With respect to an extended-monopoly drug, 65 percent.
409 75.4 - 75.5 [SEC. 11001.(a)] SEC. 1194.(c)(3)(C) LONG-MONOPOLY DRUGS. With respect to a long-monopoly drug, 40 percent.
410 75.6 - 75.6 [SEC. 11001.(a)] SEC. 1194.(c)(4) EXTENDED-MONOPOLY DRUG DEFINED.
411 75.7 - 75.16 [SEC. 11001.(a)] SEC. 1194.(c)(4)(A) IN GENERAL. In this part, subject to subparagraph (B), the term ‘extended-monopoly drug’ means, with respect to an initial price applicability year, a selected drug for which at least 12 years, but fewer than 16 years, have elapsed since the date of approval of such drug under section 505(c) of the Federal Food, Drug, and Cosmetic Act or since the date of licensure of such drug under section 351(a) of the Public Health Service Act, as applicable.
412 75.17 - 75.19 [SEC. 11001.(a)] SEC. 1194.(c)(4)(B) EXCLUSIONS. The term ‘extended-monopoly drug’ shall not include any of the following:
413 75.20 - 75.22 [SEC. 11001.(a)] SEC. 1194.(c)(4)(B)(i) A vaccine that is licensed under section 351 of the Public Health Service Act and marketed pursuant to such section.
414 75.23 - 76.2 [SEC. 11001.(a)] SEC. 1194.(c)(4)(B)(ii) A selected drug for which a manufacturer had an agreement under this part with the Secretary with respect to an initial price applicability year that is before 2030.
415 76.3 - 76.7 [SEC. 11001.(a)] SEC. 1194.(c)(4)(C) CLARIFICATION. Nothing in subparagraph (B)(ii) shall limit the transition of a selected drug described in paragraph (3)(A) to a long-monopoly drug if the selected drug meets the definition of a long-monopoly drug.
416 76.8 - 76.8 [SEC. 11001.(a)] SEC. 1194.(c)(5) LONG-MONOPOLY DRUG DEFINED.
417 76.9 - 76.18 [SEC. 11001.(a)] SEC. 1194.(c)(5)(A) IN GENERAL. In this part, subject to subparagraph (B), the term ‘long-monopoly drug’ means, with respect to an initial price applicability year, a selected drug for which at least 16 years have elapsed since the date of approval of such drug under section 505(c) of the Federal Food, Drug, and Cosmetic Act or since the date of licensure of such drug under section 351(a) of the Public Health Service Act, as applicable.
418 76.19 - 76.23 [SEC. 11001.(a)] SEC. 1194.(c)(5)(B) EXCLUSION. The term ‘long-monopoly drug’ shall not include a vaccine that is licensed under section 351 of the Public Health Service Act and marketed pursuant to such section.
419 76.24 - 77.5 [SEC. 11001.(a)] SEC. 1194.(c)(6) AVERAGE NON-FEDERAL AVERAGE MANUFACTURER PRICE. In this part, the term ‘average non-Federal average manufacturer price’ means the average of the non-Federal average manufacturer price (as defined in section 8126(h)(5) of title 38, United States Code) for the 4 calendar quarters of the year involved.
420 77.6 - 77.24 [SEC. 11001.(a)] SEC. 1194.(d) TEMPORARY FLOOR FOR SMALL BIOTECH DRUGS. In the case of a selected drug that is a qualifying single source drug described in section 1192(d)(2) and with respect to which the first initial price applicability year of the price applicability period with respect to such drug is 2029 or 2030, the maximum fair price negotiated under this section for such drug for such initial price applicability year may not be less than 66 percent of the average nonFederal average manufacturer price for such drug (as defined in subsection (c)(6)) for 2021 (or, in the case that there is not an average non-Federal average manufacturer price available for such drug for 2021, for the first full year following the market entry for such drug), increased by the percentage increase in the consumer price index for all urban consumers (all items; United States city average) from September 2021 (or December of such first full year following the market entry), as applicable, to September of the year prior to the selected drug publication date with respect to the initial price applicability year.
421 78.1 - 78.6 [SEC. 11001.(a)] SEC. 1194.(e) FACTORS. For purposes of negotiating the maximum fair price of a selected drug under this part with the manufacturer of the drug, the Secretary shall consider the following factors, as applicable to the drug, as the basis for determining the offers and counteroffers under subsection (b) for the drug:
422 78.7 - 78.9 [SEC. 11001.(a)] SEC. 1194.(e)(1) MANUFACTURER-SPECIFIC DATA. The following data, with respect to such selected drug, as submitted by the manufacturer:
423 78.10 - 78.13 [SEC. 11001.(a)] SEC. 1194.(e)(1)(A) Research and development costs of the manufacturer for the drug and the extent to which the manufacturer has recouped research and development costs.
424 78.14 - 78.15 [SEC. 11001.(a)] SEC. 1194.(e)(1)(B) Current unit costs of production and distribution of the drug.
425 78.16 - 78.18 [SEC. 11001.(a)] SEC. 1194.(e)(1)(C) Prior Federal financial support for novel therapeutic discovery and development with respect to the drug.
426 78.19 - 78.24 [SEC. 11001.(a)] SEC. 1194.(e)(1)(D) Data on pending and approved patent applications, exclusivities recognized by the Food and Drug Administration, and applications and approvals under section 505(c) of the Federal Food, Drug, and Cosmetic Act or section 351(a) of the Public Health Service Act for the drug.
427 79.1 - 79.2 [SEC. 11001.(a)] SEC. 1194.(e)(1)(E) Market data and revenue and sales volume data for the drug in the United States.
428 79.3 - 79.6 [SEC. 11001.(a)] SEC. 1194.(e)(2) EVIDENCE ABOUT ALTERNATIVE TREATMENTS. The following evidence, as available, with respect to such selected drug and therapeutic alternatives to such drug:
429 79.7 - 79.10 [SEC. 11001.(a)] SEC. 1194.(e)(2)(A) The extent to which such drug represents a therapeutic advance as compared to existing therapeutic alternatives and the costs of such existing therapeutic alternatives.
430 79.11 - 79.13 [SEC. 11001.(a)] SEC. 1194.(e)(2)(B) Prescribing information approved by the Food and Drug Administration for such drug and therapeutic alternatives to such drug.
431 79.14 - 79.20 [SEC. 11001.(a)] SEC. 1194.(e)(2)(C) Comparative effectiveness of such drug and therapeutic alternatives to such drug, taking into consideration the effects of such drug and therapeutic alternatives to such drug on specific populations, such as individuals with disabilities, the elderly, the terminally ill, children, and other patient populations.
432 79.21 - 80.7 [SEC. 11001.(a)] SEC. 1194.(e)(2)(D) The extent to which such drug and therapeutic alternatives to such drug address unmet medical needs for a condition for which treatment or diagnosis is not addressed adequately by available therapy. In using evidence described in subparagraph (C), the Secretary shall not use evidence from comparative clinical effectiveness research in a manner that treats extending the life of an elderly, disabled, or terminally ill individual as of lower value than extending the life of an individual who is younger, nondisabled, or not terminally ill.
433 80.8 - 80.8 [SEC. 11001.(a)] SEC. 1194.(f) RENEGOTIATION PROCESS.
434 80.9 - 80.15 [SEC. 11001.(a)] SEC. 1194.(f)(1) IN GENERAL. In the case of a renegotiation-eligible drug (as defined in paragraph (2)) that is selected under paragraph (3), the Secretary shall provide for a process of renegotiation (for years (beginning with 2028) during the price applicability period, with respect to such drug) of the maximum fair price for such drug consistent with paragraph (4).
435 80.16 - 80.19 [SEC. 11001.(a)] SEC. 1194.(f)(2) RENEGOTIATION-ELIGIBLE DRUG DEFINED. In this section, the term ‘renegotiation-eligible drug’ means a selected drug that is any of the following:
436 80.20 - 80.22 [SEC. 11001.(a)] SEC. 1194.(f)(2)(A) ADDITION OF NEW INDICATION. A selected drug for which a new indication is added to the drug.
437 80.23 - 80.24 [SEC. 11001.(a)] SEC. 1194.(f)(2)(B) CHANGE OF STATUS TO AN EXTENDEDMONOPOLY DRUG. A selected drug that
438 81.1 - 81.2 [SEC. 11001.(a)] SEC. 1194.(f)(2)(B)(i) is not an extended-monopoly or a long-monopoly drug; and
439 81.3 - 81.5 [SEC. 11001.(a)] SEC. 1194.(f)(2)(B)(ii) for which there is a change in status to that of an extended-monopoly drug.
440 81.6 - 81.7 [SEC. 11001.(a)] SEC. 1194.(f)(2)(C) CHANGE OF STATUS TO A LONG-MONOPOLY DRUG. A selected drug that
441 81.8 - 81.8 [SEC. 11001.(a)] SEC. 1194.(f)(2)(C)(i) is not a long-monopoly drug; and
442 81.9 - 81.10 [SEC. 11001.(a)] SEC. 1194.(f)(2)(C)(ii) for which there is a change in status to that of a long-monopoly drug.
443 81.11 - 81.14 [SEC. 11001.(a)] SEC. 1194.(f)(2)(D) MATERIAL CHANGES. A selected drug for which the Secretary determines there has been a material change of any of the factors described in paragraph (1) or (2) of subsection (e).
444 81.15 - 81.18 [SEC. 11001.(a)] SEC. 1194.(f)(3) SELECTION OF DRUGS FOR RENEGOTIATION. For each year (beginning with 2028), the Secretary shall select among renegotiation-eligible drugs for renegotiation as follows:
445 81.19 - 81.22 [SEC. 11001.(a)] SEC. 1194.(f)(3)(A) ALL EXTENDED-MONOPOLY NEGOTIATION-ELIGIBLE DRUGS. The Secretary shall select all renegotiation-eligible drugs described in paragraph (2)(B).
446 81.23 - 82.2 [SEC. 11001.(a)] SEC. 1194.(f)(3)(B) ALL LONG-MONOPOLY NEGOTIATIONELIGIBLE DRUGS. The Secretary shall select all renegotiation-eligible drugs described in paragraph (2)(C).
447 82.3 - 82.9 [SEC. 11001.(a)] SEC. 1194.(f)(3)(C) REMAINING DRUGS. Among the remaining renegotiation-eligible drugs described in subparagraphs (A) and (D) of paragraph (2), the Secretary shall select renegotiation-eligible drugs for which the Secretary expects renegotiation is likely to result in a significant change in the maximum fair price otherwise negotiated.
448 82.10 - 82.10 [SEC. 11001.(a)] SEC. 1194.(f)(4) RENEGOTIATION PROCESS.
449 82.11 - 82.15 [SEC. 11001.(a)] SEC. 1194.(f)(4)(A) IN GENERAL. The Secretary shall specify the process for renegotiation of maximum fair prices with the manufacturer of a renegotiation-eligible drug selected for renegotiation under this subsection.
450 82.16 - 83.8 [SEC. 11001.(a)] SEC. 1194.(f)(4)(B) CONSISTENT WITH NEGOTIATION PROCESS. The process specified under subparagraph (A) shall, to the extent practicable, be consistent with the methodology and process established under subsection (b) and in accordance with subsections (c), (d), and (e), and for purposes of applying subsections (c)(1)(A) and (d), the reference to the first initial price applicability year of the price applicability period with respect to such drug shall be treated as the first initial price applicability year of such period for which the maximum fair price established pursuant to such renegotiation applies, including for applying subsection (c)(3)(B) in the case of renegotiation-eligible drugs described in paragraph (3)(A) of this subsection and subsection (c)(3)(C) in the case of renegotiation-eligible drugs described in paragraph (3)(B) of this subsection.
452 83.9 - 83.13 [SEC. 11001.(a)] SEC. 1194.(f)(5) CLARIFICATION. A renegotiation-eligible drug for which the Secretary makes a determination described in section 1192(c)(1) before or during the period of renegotiation shall not be subject to the renegotiation process under this section.
453 83.14 - 83.18 [SEC. 11001.(a)] SEC. 1194.(g) CLARIFICATION. The maximum fair price for a selected drug described in subparagraph (A) or (B) of paragraph (1) shall take effect no later than the first day of the first calendar quarter that begins after the date described in subparagraph (A) or (B), as applicable.
454 83.19 - 83.19 [SEC. 11001.(a)] PART E SEC. 1195. PUBLICATION OF MAXIMUM FAIR PRICES.
455 83.20 - 83.22 [SEC. 11001.(a)] SEC. 1195.(a) IN GENERAL. With respect to an initial price applicability year and a selected drug with respect to such year
456 83.23 - 84.2 [SEC. 11001.(a)] SEC. 1195.(a)(1) not later than November 30 of the year that is 2 years prior to such initial price applicability year, the Secretary shall publish the maximum fair price for such drug negotiated with the manufacturer of such drug under this part; and
457 84.3 - 84.8 [SEC. 11001.(a)] SEC. 1195.(a)(2) not later than March 1 of the year prior to such initial price applicability year, the Secretary shall publish, subject to section 1193(c), the explanation for the maximum fair price with respect to the factors as applied under section 1194(e) for such drug described in paragraph (1).
458 84.9 - 84.9 [SEC. 11001.(a)] SEC. 1195.(b) UPDATES.
459 84.10 - 84.19 [SEC. 11001.(a)] SEC. 1195.(b)(1) SUBSEQUENT YEAR MAXIMUM FAIR PRICES. For a selected drug, for each year subsequent to the first initial price applicability year of the price applicability period with respect to such drug, with respect to which an agreement for such drug is in effect under section 1193, not later than November 30 of the year that is 2 years prior to such subsequent year, the Secretary shall publish the maximum fair price applicable to such drug and year, which shall be
460 84.20 - 85.2 [SEC. 11001.(a)] SEC. 1195.(b)(1)(A) subject to subparagraph (B), the amount equal to the maximum fair price published for such drug for the previous year, increased by the annual percentage increase in the consumer price index for all urban consumers (all items; United States city average) for the 12-month period ending with the July immediately preceding such November 30; or
461 85.3 - 85.6 [SEC. 11001.(a)] SEC. 1195.(b)(1)(B) in the case the maximum fair price for such drug was renegotiated, for the first year for which such price as so renegotiated applies, such renegotiated maximum fair price.
462 85.7 - 85.14 [SEC. 11001.(a)] SEC. 1195.(b)(2) PRICES NEGOTIATED AFTER DEADLINE. In the case of a selected drug with respect to an initial price applicability year for which the maximum fair price is determined under this part after the date of publication under this section, the Secretary shall publish such maximum fair price by not later than 30 days after the date such maximum price is so determined.
463 85.15 - 85.16 [SEC. 11001.(a)] PART E SEC. 1196. ADMINISTRATIVE DUTIES AND COMPLIANCE MONITORING.
464 85.17 - 85.19 [SEC. 11001.(a)] SEC. 1196.(a) ADMINISTRATIVE DUTIES. For purposes of section 1191(a)(4), the administrative duties described in this section are the following:
465 85.20 - 85.22 [SEC. 11001.(a)] SEC. 1196.(a)(1) The establishment of procedures to ensure that the maximum fair price for a selected drug is applied before
466 85.23 - 86.3 [SEC. 11001.(a)] SEC. 1196.(a)(1)(A) any coverage or financial assistance under other health benefit plans or programs that provide coverage or financial assistance for the purchase or provision of prescription drug coverage on behalf of maximum fair price eligible individuals; and
467 86.4 - 86.4 [SEC. 11001.(a)] SEC. 1196.(a)(1)(B) any other discounts.
468 86.5 - 86.9 [SEC. 11001.(a)] SEC. 1196.(a)(2) The establishment of procedures to compute and apply the maximum fair price across different strengths and dosage forms of a selected drug and not based on the specific formulation or package size or package type of such drug.
469 86.10 - 86.12 [SEC. 11001.(a)] SEC. 1196.(a)(3) The establishment of procedures to carry out the provisions of this part, as applicable, with respect to
470 86.13 - 86.16 [SEC. 11001.(a)] SEC. 1196.(a)(3)(A) maximum fair price eligible individuals who are enrolled in a prescription drug plan under part D of title XVIII or an MA–PD plan under part C of such title; and
471 86.17 - 86.20 [SEC. 11001.(a)] SEC. 1196.(a)(3)(B) maximum fair price eligible individuals who are enrolled under part B of such title, including who are enrolled in an MA plan under part C of such title.
472 86.21 - 86.23 [SEC. 11001.(a)] SEC. 1196.(a)(4) The establishment of a negotiation process and renegotiation process in accordance with section 1194.
473 87.1 - 87.3 [SEC. 11001.(a)] SEC. 1196.(a)(5) The establishment of a process for manufacturers to submit information described in section 1194(b)(2)(A).
474 87.4 - 87.11 [SEC. 11001.(a)] SEC. 1196.(a)(6) The sharing with the Secretary of the Treasury of such information as is necessary to determine the tax imposed by section 5000D of the Internal Revenue Code of 1986, including the application of such tax to a manufacturer, producer, or importer or the determination of any date described in section 5000D(c)(1) of such Code. For purposes of the preceding sentence, such information shall include
475 87.12 - 87.17 [SEC. 11001.(a)] SEC. 1196.(a)(6)(A) the date on which the Secretary receives notification of any termination of an agreement under the Medicare coverage gap discount program under section 1860D-14A and the date on which any subsequent agreement under such program is entered into;
476 87.18 - 87.23 [SEC. 11001.(a)] SEC. 1196.(a)(6)(B) the date on which the Secretary receives notification of any termination of an agreement under the manufacturer discount program under section 1860D-14C and the date on which any subsequent agreement under such program is entered into; and
477 87.24 - 88.3 [SEC. 11001.(a)] SEC. 1196.(a)(6)(C) the date on which the Secretary receives notification of any termination of a rebate agreement described in section 1927(b) and the date on which any subsequent rebate agreement described in such section is entered into.
478 88.4 - 88.5 [SEC. 11001.(a)] SEC. 1196.(a)(7) The establishment of procedures for purposes of applying section 1192(d)(2)(B).
479 88.6 - 88.10 [SEC. 11001.(a)] SEC. 1196.(b) COMPLIANCE MONITORING. The Secretary shall monitor compliance by a manufacturer with the terms of an agreement under section 1193 and establish a mechanism through which violations of such terms shall be reported.
480 88.11 - 88.11 [SEC. 11001.(a)] PART E SEC. 1197. CIVIL MONETARY PENALTIES.
481 88.12 - 88.18 [SEC. 11001.(a)] SEC. 1197.(a) VIOLATIONS RELATING TO OFFERING OF MAXIMUM FAIR PRICE. Any manufacturer of a selected drug that has entered into an agreement under section 1193, with respect to a year during the price applicability period with respect to such drug, that does not provide access to a price that is equal to or less than the maximum fair price for such drug for such year
482 88.19 - 88.25 [SEC. 11001.(a)] SEC. 1197.(a)(1) to a maximum fair price eligible individual who with respect to such drug is described in subparagraph (A) of section 1191(c)(2) and who is dispensed such drug during such year (and to pharmacies, mail order services, and other dispensers, with respect to such maximum fair price eligible individuals who are dispensed such drugs); or
483 89.1 - 89.15 [SEC. 11001.(a)] SEC. 1197.(a)(2) to a hospital, physician, or other provider of services or supplier with respect to maximum fair price eligible individuals who with respect to such drug is described in subparagraph (B) of such section and is furnished or administered such drug by such hospital, physician, or provider or supplier during such year; shall be subject to a civil monetary penalty equal to ten times the amount equal to the product of the number of units of such drug so furnished, dispensed, or administered during such year and the difference between the price for such drug made available for such year by such manufacturer with respect to such individual or hospital, physician, provider of services, or supplier and the maximum fair price for such drug for such year.
484 89.16 - 89.24 [SEC. 11001.(a)] SEC. 1197.(b) VIOLATIONS OF CERTAIN TERMS OF AGREEMENT. Any manufacturer of a selected drug that has entered into an agreement under section 1193, with respect to a year during the price applicability period with respect to such drug, that is in violation of a requirement imposed pursuant to section 1193(a)(5), including the requirement to submit information pursuant to section 1193(a)(4), shall be subject to a civil monetary penalty equal to $1,000,000 for each day of such violation.
485 90.1 - 90.4 [SEC. 11001.(a)] SEC. 1197.(c) FALSE INFORMATION. Any manufacturer that knowingly provides false information pursuant to section 1196(a)(7) shall be subject to a civil monetary penalty equal to $100,000,000 for each item of such false information.
486 90.5 - 90.9 [SEC. 11001.(a)] SEC. 1197.(d) APPLICATION. The provisions of section 1128A (other than subsections (a) and (b)) shall apply to a civil monetary penalty under this section in the same manner as such provisions apply to a penalty or proceeding under section 1128A(a).
487 90.10 - 90.13 [SEC. 11001.(a)] PART E SEC. 1198. LIMITATION ON ADMINISTRATIVE AND JUDICIAL REVIEW. ‘‘There shall be no administrative or judicial review of any of the following:
488 90.14 - 90.16 [SEC. 11001.(a)] SEC. 1198.(1) The determination of a unit, with respect to a drug or biological product, pursuant to section 1191(c)(6).
489 90.17 - 90.20 [SEC. 11001.(a)] SEC. 1198.(2) The selection of drugs under section 1192(b), the determination of negotiation-eligible drugs under section 1192(d), and the determination of qualifying single source drugs under section 1192(e).
490 90.21 - 90.22 [SEC. 11001.(a)] SEC. 1198.(3) The determination of a maximum fair price under subsection (b) or (f) of section 1194.
491 90.23 - 90.25 [SEC. 11001.(a)] SEC. 1198.(4) The determination of renegotiation-eligible drugs under section 1194(f)(2) and the selection of renegotiation-eligible drugs under section 1194(f)(3).’’.
492 91.1 - 91.2 SEC. 11001.(b) APPLICATION OF MAXIMUM FAIR PRICES AND CONFORMING AMENDMENTS.
493 91.3 - 91.3 SEC. 11001.(b)(1) UNDER MEDICARE.
494 91.4 - 91.14 SEC. 11001.(b)(1)(A) APPLICATION TO PAYMENTS UNDER PART B. Section 1847A(b)(1)(B) of the Social Security Act (42 U.S.C. 1395w–3a(b)(1)(B)) is amended by inserting ‘‘or in the case of such a drug or biological product that is a selected drug (as referred to in section 1192(c)), with respect to a price applicability period (as defined in section 1191(b)(2)), 106 percent of the maximum fair price (as defined in section 1191(c)(3)) applicable for such drug and a year during such period’’ after ‘‘paragraph (4)’’.
496 91.15 - 91.19 SEC. 11001.(b)(1)(B) APPLICATION UNDER MA OF COSTSHARING FOR PART B DRUGS BASED OFF OF NEGOTIATED PRICE. Section 1852(a)(1)(B)(iv) of the Social Security Act (42 U.S.C. 1395w– 22(a)(1)(B)(iv)) is amended
497 91.20 - 91.21 SEC. 11001.(b)(1)(B)(i) by redesignating subclause (VII) as subclause (VIII); and
498 91.22 - 91.23 SEC. 11001.(b)(1)(B)(ii) by inserting after subclause (VI) the following subclause:
499 92.1 - 92.3 [SEC. 11001.(b)(1)(B)(ii)] (VII) A drug or biological product that is a selected drug (as referred to in section 1192(c)).’’.
500 92.4 - 92.7 SEC. 11001.(b)(1)(C) EXCEPTION TO PART D NON-INTERFERENCE. Section 1860D–11(i) of the Social Security Act (42 U.S.C. 1395w–111(i)) is amended
501 92.8 - 92.9 SEC. 11001.(b)(1)(C)(i) in paragraph (1), by striking ‘‘and’’ at the end;
502 92.10 - 92.14 SEC. 11001.(b)(1)(C)(ii) in paragraph (2), by striking ‘‘or institute a price structure for the reimbursement of covered part D drugs.’’ and inserting ‘‘, except as provided under section 1860D–4(b)(3)(l); and’’; and
503 92.15 - 92.16 SEC. 11001.(b)(1)(C)(iii) by adding at the end the following new paragraph:
504 92.17 - 92.19 [SEC. 11001.(b)(1)(C)(iii)] (3) may not institute a price structure for the reimbursement of covered part D drugs, except as provided under part E of title XI.’’.
505 92.20 - 92.23 SEC. 11001.(b)(1)(D) APPLICATION AS NEGOTIATED PRICE UNDER PART D. Section 1860D–2(d)(1) of the Social Security Act (42 U.S.C. 1395w– 102(d)(1)) is amended
506 93.1 - 93.3 SEC. 11001.(b)(1)(D)(i) in subparagraph (B), by inserting ‘‘, subject to subparagraph (D),’’ after ‘‘negotiated prices’’; and
507 93.4 - 93.5 SEC. 11001.(b)(1)(D)(ii) by adding at the end the following new subparagraph:
508 93.6 - 93.17 [SEC. 11001.(b)(1)(D)(ii)] (D) APPLICATION OF MAXIMUM FAIR PRICE FOR SELECTED DRUGS. In applying this section, in the case of a covered part D drug that is a selected drug (as referred to in section 1192(c)), with respect to a price applicability period (as defined in section 1191(b)(2)), the negotiated prices used for payment (as described in this subsection) shall be no greater than the maximum fair price (as defined in section 1191(c)(3)) for such drug and for each year during such period plus any dispensing fees for such drug.’’.
509 93.18 - 93.22 SEC. 11001.(b)(1)(E) COVERAGE OF SELECTED DRUGS. Section 1860D–4(b)(3) of the Social Security Act (42 U.S.C. 1395w–104(b)(3)) is amended by adding at the end the following new subparagraph:
510 93.23 - 93.24 [SEC. 11001.(b)(1)(E)] (I) REQUIRED INCLUSION OF SELECTED DRUGS.
511 94.1 - 94.7 [SEC. 11001.(b)(1)(E)] (i) IN GENERAL. For 2026 and each subsequent year, the PDP sponsor offering a prescription drug plan shall include each covered part D drug that is a selected drug under section 1192 for which a maximum fair price (as defined in section 1191(c)(3)) is in effect with respect to the year.
512 94.8 - 94.14 [SEC. 11001.(b)(1)(E)] (ii) CLARIFICATION. Nothing in clause (i) shall be construed as prohibiting a PDP sponsor from removing such a selected drug from a formulary if such removal would be permitted under section 423.120(b)(5)(iv) of title 42, Code of Federal Regulations (or any successor regulation).’’.
513 94.15 - 94.16 SEC. 11001.(b)(1)(F) INFORMATION FROM PRESCRIPTION DRUG PLANS AND MA–PD PLANS REQUIRED.
514 94.17 - 94.21 SEC. 11001.(b)(1)(F)(i) PRESCRIPTION DRUG PLANS. Section 1860D–12(b) of the Social Security Act (42 U.S.C. 1395w–112(b)) is amended by adding at the end the following new paragraph:
515 94.22 - 95.3 [SEC. 11001.(b)(1)(F)(i)] (8) PROVISION OF INFORMATION RELATED TO MAXIMUM FAIR PRICES. Each contract entered into with a PDP sponsor under this part with respect to a prescription drug plan offered by such sponsor shall require the sponsor to provide information to the Secretary as requested by the Secretary for purposes of carrying out section 1194.’’.
516 95.4 - 95.8 SEC. 11001.(b)(1)(F)(ii) MA–PD PLANS. Section 1857(f)(3) of the Social Security Act (42 U.S.C. 1395w–27(f)(3)) is amended by adding at the end the following new subparagraph:
517 95.9 - 95.11 [SEC. 11001.(b)(1)(F)(ii)] (E) PROVISION OF INFORMATION RELATED TO MAXIMUM FAIR PRICES. Section 1860D– 12(b)(8).’’.
518 95.12 - 95.12 SEC. 11001.(b)(1)(G) CONDITIONS FOR COVERAGE.
519 95.13 - 95.15 SEC. 11001.(b)(1)(G)(i) MEDICARE PART D. Section 1860D–43(c) of the Social Security Act (42 U.S.C. 1395w–153(c)) is amended
520 95.16 - 95.18 SEC. 11001.(b)(1)(G)(i)(I) by redesignating paragraphs (1) and (2) as subparagraphs (A) and (B), respectively;
523 95.19 - 95.23 SEC. 11001.(b)(1)(G)(i)(II) by striking ‘‘AGREEMENTS. Subsection’’ and inserting the following: ‘‘AGREEMENTS. (1) IN GENERAL. Subject to paragraph (2), subsection’’; and
525 95.24 - 95.25 SEC. 11001.(b)(1)(G)(i)(III) by adding at the end the following new paragraph:
526 96.1 - 96.5 [SEC. 11001.(b)(1)(G)(i)(III)] (2) EXCEPTION. Paragraph (1)(A) shall not apply to a covered part D drug of a manufacturer for any period described in section 5000D(c)(1) of the Internal Revenue Code of 1986 with respect to the manufacturer.’’.
527 96.6 - 96.15 SEC. 11001.(b)(1)(G)(ii) MEDICAID AND MEDICARE PART B. Section 1927(a)(3) of the Social Security Act (42 U.S.C. 1396r–8(a)(3)) is amended by adding at the end the following new sentence: ‘‘The preceding sentence shall not apply to a single source drug or innovator multiple source drug of a manufacturer for any period described in section 5000D(c)(1) of the Internal Revenue Code of 1986 with respect to the manufacturer.’’.
528 96.16 - 96.17 SEC. 11001.(b)(1)(H) DISCLOSURE OF INFORMATION UNDER MEDICARE PART D.
529 96.18 - 96.23 SEC. 11001.(b)(1)(H)(i) CONTRACT REQUIREMENTS. Section 1860D–12(b)(3)(D)(i) of the Social Security Act (42 U.S.C. 1395w– 112(b)(3)(D)(i)) is amended by inserting ‘‘, or carrying out part E of title XI’’ after ‘‘appropriate)’’.
530 96.24 - 97.3 SEC. 11001.(b)(1)(H)(ii) SUBSIDIES. Section 1860D– 15(f)(2)(A)(i) of the Social Security Act (42 U.S.C. 1395w–115(f)(2)(A)(i)) is amended by inserting ‘‘or part E of title XI’’ after ‘‘this section’’.
531 97.4 - 97.7 SEC. 11001.(b)(2) DRUG PRICE NEGOTIATION PROGRAM PRICES INCLUDED IN BEST PRICE. Section 1927(c)(1)(C) of the Social Security Act (42 U.S.C. 1396r–8(c)(1)(C)) is amended
532 97.8 - 97.10 SEC. 11001.(b)(2)(A) in clause (i)(VI), by striking ‘‘any prices charged’’ and inserting ‘‘subject to clause (ii)(V), any prices charged’’; and
534 97.11 - 97.11 SEC. 11001.(b)(2)(B) in clause (ii)
535 97.12 - 97.13 SEC. 11001.(b)(2)(B)(i) in subclause (III), by striking ‘‘; and’’ at the end;
536 97.14 - 97.16 SEC. 11001.(b)(2)(B)(ii) in subclause (IV), by striking the period at the end and inserting ‘‘; and’’; and
537 97.17 - 97.18 SEC. 11001.(b)(2)(B)(iii) by adding at the end the following new subclause:
538 97.19 - 98.2 [SEC. 11001.(b)(2)(B)(iii)] (V) in the case of a rebate period and a covered outpatient drug that is a selected drug (as referred to in section 1192(c)) during such rebate period, shall be inclusive of the maximum fair price (as defined in section 1191(c)(3)) for such drug with respect to such period.’’.
539 98.3 - 98.6 SEC. 11001.(b)(3) MAXIMUM FAIR PRICES EXCLUDED FROM AVERAGE MANUFACTURER PRICE. Section 1927(k)(1)(B)(i) of the Social Security Act (42 U.S.C. 1396r–8(k)(1)(B)(i)) is amended
540 98.7 - 98.8 SEC. 11001.(b)(3)(A) in subclause (IV) by striking ‘‘; and’’ at the end;
541 98.9 - 98.10 SEC. 11001.(b)(3)(B) in subclause (V) by striking the period at the end and inserting ‘‘; and’’; and
542 98.11 - 98.12 SEC. 11001.(b)(3)(C) by adding at the end the following new subclause:
543 98.13 - 98.16 [SEC. 11001.(b)(3)(C)] (VI) any reduction in price paid during the rebate period to the manufacturer for a drug by reason of application of part E of title XI.’’.
544 98.17 - 98.21 SEC. 11001.(c) IMPLEMENTATION FOR 2026 THROUGH 2028. The Secretary of Health and Human Services shall implement this section, including the amendments made by this section, for 2026, 2027, and 2028 by program instruction or other forms of program guidance.
545 99.1 - 99.3 TITLE I Subtitle B PART 1 SEC. 11002. SPECIAL RULE TO DELAY SELECTION AND NEGOTIATION OF BIOLOGICS FOR BIOSIMILAR MARKET ENTRY.
546 99.4 - 99.5 SEC. 11002.(a) IN GENERAL. Part E of title XI of the Social Security Act, as added by section 11001, is amended
547 99.6 - 99.6 SEC. 11002.(a)(1) in section 1192
548 99.7 - 99.9 SEC. 11002.(a)(1)(A) in subsection (a), in the flush matter following paragraph (4), by inserting ‘‘and subsection (b)(3)’’ after ‘‘the previous sentence’’;
549 99.10 - 99.10 SEC. 11002.(a)(1)(B) in subsection (b)
550 99.11 - 99.12 SEC. 11002.(a)(1)(B)(i) in paragraph (1), by adding at the end the following new subparagraph:
551 99.13 - 99.19 [SEC. 11002.(a)(1)(B)(i)] (C) In the case of a biological product for which the inclusion of the biological product as a selected drug on a list published under subsection (a) has been delayed under subsection (f)(2), remove such biological product from the rankings under subparagraph (A) before making the selections under subparagraph (B).’’; and
553 99.20 - 99.21 SEC. 11002.(a)(1)(B)(ii) by adding at the end the following new paragraph:
554 99.22 - 100.3 [SEC. 11002.(a)(1)(B)(ii)] (3) INCLUSION OF DELAYED BIOLOGICAL PRODUCTS. Pursuant to subparagraphs (B)(ii)(I) and (C)(i) of subsection (f)(2), the Secretary shall select and include on the list published under subsection (a) the biological products described in such subparagraphs. Such biological products shall count towards the required number of drugs to be selected under subsection (a)(1).’’; and
556 100.4 - 100.5 SEC. 11002.(a)(1)(C) by adding at the end the following new subsection:
557 100.6 - 100.8 [SEC. 11002.(a)(1)(C)] (f) SPECIAL RULE TO DELAY SELECTION AND NEGOTIATION OF BIOLOGICS FOR BIOSIMILAR MARKET ENTRY.
558 100.9 - 100.9 [SEC. 11002.(a)(1)(C)] (f)(1) APPLICATION.
559 100.10 - 101.2 [SEC. 11002.(a)(1)(C)] (f)(1)(A) IN GENERAL. Subject to subparagraph (B), in the case of a biological product that would (but for this subsection) be an extended-monopoly drug (as defined in section 1194(c)(4)) included as a selected drug on the list published under subsection (a) with respect to an initial price applicability year, the rules described in paragraph (2) shall apply if the Secretary determines that there is a high likelihood (as described in paragraph (3)) that a biosimilar biological product (for which such biological product will be the reference product) will be licensed and marketed under section 351(k) of the Public Health Service Act before the date that is 2 years after the selected drug publication date with respect to such initial price applicability year.
560 101.3 - 101.3 [SEC. 11002.(a)(1)(C)] (f)(1)(B) REQUEST REQUIRED.
561 101.4 - 101.5 [SEC. 11002.(a)(1)(C)] (f)(1)(B)(i) IN GENERAL. The Secretary shall not provide for a delay under
562 101.6 - 101.16 [SEC. 11002.(a)(1)(C)] (f)(1)(B)(i)(I) paragraph (2)(A) unless a request is made for such a delay by a manufacturer of a biosimilar biological product prior to the selected drug publication date for the list published under subsection (a) with respect to the initial price applicability year for which the biological product may have been included as a selected drug on such list but for subparagraph (2)(A); or
563 101.17 - 102.3 [SEC. 11002.(a)(1)(C)] (f)(1)(B)(i)(II) paragraph (2)(B)(iii) unless a request is made for such a delay by such a manufacturer prior to the selected drug publication date for the list published under subsection (a) with respect to the initial price applicability year that is 1 year after the initial price applicability year for which the biological product described in subsection (a) would have been included as a selected drug on such list but for paragraph (2)(A).
564 102.4 - 102.5 [SEC. 11002.(a)(1)(C)] (f)(1)(B)(ii) INFORMATION AND DOCUMENTS.
565 102.6 - 102.11 [SEC. 11002.(a)(1)(C)] (f)(1)(B)(ii)(I) IN GENERAL. A request made under clause (i) shall be submitted to the Secretary by such manufacturer at a time and in a form and manner specified by the Secretary, and contain
566 102.12 - 102.18 [SEC. 11002.(a)(1)(C)] (f)(1)(B)(ii)(I)(aa) information and documents necessary for the Secretary to make determinations under this subsection, as specified by the Secretary and including, to the extent available, items described in subclause (III); and
567 102.19 - 103.2 [SEC. 11002.(a)(1)(C)] (f)(1)(B)(ii)(I)(bb) all agreements related to the biosimilar biological product filed with the Federal Trade Commission or the Assistant Attorney General pursuant to subsections (a) and (c) of section 1112 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003.
568 103.3 - 103.11 [SEC. 11002.(a)(1)(C)] (f)(1)(B)(ii)(II) ADDITIONAL INFORMATION AND DOCUMENTS. After the Secretary has reviewed the request and materials submitted under subclause (I), the manufacturer shall submit any additional information and documents requested by the Secretary necessary to make determinations under this subsection.
569 103.12 - 103.14 [SEC. 11002.(a)(1)(C)] (f)(1)(B)(ii)(III) ITEMS DESCRIBED. The items described in this clause are the following:
570 103.15 - 103.20 [SEC. 11002.(a)(1)(C)] (f)(1)(B)(ii)(III)(aa) The manufacturing schedule for such biosimilar biological product submitted to the Food and Drug Administration during its review of the application under such section 351(k).
571 103.21 - 104.14 [SEC. 11002.(a)(1)(C)] (f)(1)(B)(ii)(III)(bb) Disclosures (in filings by the manufacturer of such biosimilar biological product with the Securities and Exchange Commission required under section 12(b), 12(g), 13(a), or 15(d) of the Securities Exchange Act of 1934 about capital investment, revenue expectations, and actions taken by the manufacturer that are typical of the normal course of business in the year (or the 2 years, as applicable) before marketing of a biosimilar biological product) that pertain to the marketing of such biosimilar biological product, or comparable documentation that is distributed to the shareholders of privately held companies.
572 104.15 - 104.15 [SEC. 11002.(a)(1)(C)] (f)(1)(C) AGGREGATION RULE.
573 104.16 - 104.21 [SEC. 11002.(a)(1)(C)] (f)(1)(C)(i) IN GENERAL. All persons treated as a single employer under subsection (a) or (b) of section 52 of the Internal Revenue Code of 1986, or in a partnership, shall be treated as one manufacturer for purposes of paragraph (2)(D)(iv).
575 104.22 - 105.4 [SEC. 11002.(a)(1)(C)] (f)(1)(C)(ii) PARTNERSHIP DEFINED. In clause (i), the term ‘partnership’ means a syndicate, group, pool, joint venture, or other organization through or by means of which any business, financial operation, or venture is carried on by the manufacturer of the biological product and the manufacturer of the biosimilar biological product.
576 105.5 - 105.6 [SEC. 11002.(a)(1)(C)] (f)(2) RULES DESCRIBED. The rules described in this paragraph are the following:
577 105.7 - 105.17 [SEC. 11002.(a)(1)(C)] (f)(2)(A) DELAYED SELECTION AND NEGOTIATION FOR 1 YEAR. If a determination of high likelihood is made under paragraph (3), the Secretary shall delay the inclusion of the biological product as a selected drug on the list published under subsection (a) until such list is published with respect to the initial price applicability year that is 1 year after the initial price applicability year for which the biological product would have been included as a selected drug on such list.
578 105.18 - 105.19 [SEC. 11002.(a)(1)(C)] (f)(2)(B) IF NOT LICENSED AND MARKETED DURING THE INITIAL DELAY.
579 105.20 - 106.15 [SEC. 11002.(a)(1)(C)] (f)(2)(B)(i) IN GENERAL. If, during the time period between the selected drug publication date on which the biological product would have been included on the list as a selected drug pursuant to subsection (a) but for subparagraph (A) and the selected drug publication date with respect to the initial price applicability year that is 1 year after the initial price applicability year for which such biological product would have been included as a selected drug on such list, the Secretary determines that the biosimilar biological product for which the manufacturer submitted the request under paragraph (1)(B)(i)(II) (and for which the Secretary previously made a high likelihood determination under paragraph (3)) has not been licensed and marketed under section 351(k) of the Public Health Service Act, the Secretary shall, at the request of such manufacturer
581 106.16 - 107.2 [SEC. 11002.(a)(1)(C)] (f)(2)(B)(i)(I) reevaluate whether there is a high likelihood (as described in paragraph (3)) that such biosimilar biological product will be licensed and marketed under such section 351(k) before the date that is 2 years after the selected drug publication date for which such biological product would have been included as a selected drug on such list published but for subparagraph (A); and
582 107.3 - 107.16 [SEC. 11002.(a)(1)(C)] (f)(2)(B)(i)(II) evaluate whether, on the basis of clear and convincing evidence, the manufacturer of such biosimilar biological product has made a significant amount of progress (as determined by the Secretary) towards both such licensure and the marketing of such biosimilar biological product (based on information from items described in subclauses (I)(bb) and (II) of paragraph (1)(B)(ii)) since the receipt by the Secretary of the request made by such manufacturer under paragraph (1)(B)(i)(I).
584 107.17 - 107.23 [SEC. 11002.(a)(1)(C)] (f)(2)(B)(ii) SELECTION AND NEGOTIATION. If the Secretary determines that there is not a high likelihood that such biosimilar biological product will be licensed and marketed as described in clause (i)(I) or there has not been a significant amount of progress as described in clause (i)(II)
585 107.24 - 108.8 [SEC. 11002.(a)(1)(C)] (f)(2)(B)(ii)(I) the Secretary shall include the biological product as a selected drug on the list published under subsection (a) with respect to the initial price applicability year that is 1 year after the initial price applicability year for which such biological product would have been included as a selected drug on such list but for subparagraph (A); and
587 108.9 - 108.15 [SEC. 11002.(a)(1)(C)] (f)(2)(B)(ii)(II) the manufacturer of such biological product shall pay a rebate under paragraph (4) with respect to the year for which such manufacturer would have provided access to a maximum fair price for such biological product but for subparagraph (A).
588 108.16 - 109.9 [SEC. 11002.(a)(1)(C)] (f)(2)(B)(iii) SECOND 1-YEAR DELAY. If the Secretary determines that there is a high likelihood that such biosimilar biological product will be licensed and marketed (as described in clause (i)(I)) and a significant amount of progress has been made by the manufacturer of such biosimilar biological product towards such licensure and marketing (as described in clause (i)(II)), the Secretary shall delay the inclusion of the biological product as a selected drug on the list published under subsection (a) until the selected drug publication date of such list with respect to the initial price applicability year that is 2 years after the initial price applicability year for which such biological product would have been included as a selected drug on such list but for this subsection.
589 109.10 - 109.23 [SEC. 11002.(a)(1)(C)] (f)(2)(C) IF NOT LICENSED AND MARKETED DURING THE YEAR TWO DELAY. If, during the time period between the selected drug publication date of the list for which the biological product would have been included as a selected drug but for subparagraph (B)(iii) and the selected drug publication date with respect to the initial price applicability year that is 2 years after the initial price applicability year for which such biological product would have been included as a selected drug on such list but for this subsection, the Secretary determines that such biosimilar biological product has not been licensed and marketed
590 109.24 - 110.5 [SEC. 11002.(a)(1)(C)] (f)(2)(C)(i) the Secretary shall include such biological product as a selected drug on such list with respect to the initial price applicability year that is 2 years after the initial price applicability year for which such biological product would have been included as a selected drug on such list; and
591 110.6 - 110.12 [SEC. 11002.(a)(1)(C)] (f)(2)(C)(ii) the manufacturer of such biological product shall pay a rebate under paragraph (4) with respect to the years for which such manufacturer would have provided access to a maximum fair price for such biological product but for this subsection.
592 110.13 - 110.13 [SEC. 11002.(a)(1)(C)] (f)(2)(D) LIMITATIONS ON DELAYS.
593 110.14 - 110.17 [SEC. 11002.(a)(1)(C)] (f)(2)(D)(i) LIMITED TO 2 YEARS. In no case shall the Secretary delay the inclusion of a biological product on the list published under subsection (a) for more than 2 years.
594 110.18 - 111.5 [SEC. 11002.(a)(1)(C)] (f)(2)(D)(ii) EXCLUSION OF BIOLOGICAL PRODUCTS THAT TRANSITIONED TO A LONGMONOPOLY DRUG DURING THE DELAY. In the case of a biological product for which the inclusion on the list published pursuant to subsection (a) was delayed by 1 year under subparagraph (A) and for which there would have been a change in status to a long-monopoly drug (as defined in section 1194(c)(5)) if such biological product had been a selected drug, in no case may the Secretary provide for a second 1-year delay under subparagraph (B)(iii).
595 111.6 - 111.16 [SEC. 11002.(a)(1)(C)] (f)(2)(D)(iii) EXCLUSION OF BIOLOGICAL PRODUCTS IF MORE THAN 1 YEAR SINCE LICENSURE. In no case shall the Secretary delay the inclusion of a biological product on the list published under subsection (a) if more than 1 year has elapsed since the biosimilar biological product has been licensed under section 351(k) of the Public Health Service Act and marketing has not commenced for such biosimilar biological product.
596 111.17 - 111.25 [SEC. 11002.(a)(1)(C)] (f)(2)(D)(iv) CERTAIN MANUFACTURERS OF BIOSIMILAR BIOLOGICAL PRODUCTS EXCLUDED. In no case shall the Secretary delay the inclusion of a biological product as a selected drug on the list published under subsection (a) if Secretary determined that the manufacturer of the biosimilar biological product described in paragraph (1)(A)
597 112.1 - 112.5 [SEC. 11002.(a)(1)(C)] (f)(2)(D)(iv)(I) is the same as the manufacturer of the reference product described in such paragraph or is treated as being the same pursuant to paragraph (1)(C); or
599 112.6 - 112.12 [SEC. 11002.(a)(1)(C)] (f)(2)(D)(iv)(II) has, based on information from items described in paragraph (1)(B)(ii)(I)(bb), entered into any agreement described in such paragraph with the manufacturer of the reference product described in paragraph (1)(A) that
601 112.13 - 112.17 [SEC. 11002.(a)(1)(C)] (f)(2)(D)(iv)(II)(aa) requires or incentivizes the manufacturer of the biosimilar biological product to submit a request described in paragraph (1)(B); or
603 112.18 - 112.23 [SEC. 11002.(a)(1)(C)] (f)(2)(D)(iv)(II)(bb) restricts the quantity (either directly or indirectly) of the biosimilar biological product that may be sold in the United States over a specified period of time.
604 112.24 - 113.2 [SEC. 11002.(a)(1)(C)] (f)(3) HIGH LIKELIHOOD. For purposes of this subsection, there is a high likelihood described in paragraph (1) or paragraph (2), as applicable, if the Secretary finds that
605 113.3 - 113.7 [SEC. 11002.(a)(1)(C)] (f)(3)(A) an application for licensure under section 351(k) of the Public Health Service Act for the biosimilar biological product has been accepted for review or approved by the Food and Drug Administration; and
606 113.8 - 113.15 [SEC. 11002.(a)(1)(C)] (f)(3)(B) information from items described in sub clauses (I)(bb) and (III) of paragraph (1)(B)(ii) submitted to the Secretary by the manufacturer requesting a delay under such paragraph provides clear and convincing evidence that such biosimilar biological product will, within the time period specified under paragraph (1)(A) or (2)(B)(i)(I), be marketed.
608 113.16 - 113.16 [SEC. 11002.(a)(1)(C)] (f)(4) REBATE.
609 113.17 - 114.2 [SEC. 11002.(a)(1)(C)] (f)(4)(A) IN GENERAL. For purposes of subparagraphs (B)(ii)(II) and (C)(ii) of paragraph (2), in the case of a biological product for which the inclusion on the list under subsection (a) was delayed under this subsection and for which the Secretary has negotiated and entered into an agreement under section 1193 with respect to such biological product, the manufacturer shall be required to pay a rebate to the Secretary at such time and in such manner as determined by the Secretary.
611 114.3 - 114.6 [SEC. 11002.(a)(1)(C)] (f)(4)(B) AMOUNT. Subject to subparagraph (C), the amount of the rebate under subparagraph (A) with respect to a biological product shall be equal to the estimated amount
613 114.7 - 114.10 [SEC. 11002.(a)(1)(C)] (f)(4)(B)(i) in the case of a biological product that is a covered part D drug (as defined in section 1860D–2(e)), that is the sum of the products of
614 114.11 - 114.12 [SEC. 11002.(a)(1)(C)] (f)(4)(B)(i)(I) 75 percent of the amount by which
615 114.13 - 115.2 [SEC. 11002.(a)(1)(C)] (f)(4)(B)(i)(I)(aa) the average manufacturer price, as reported by the manufacturer of such covered part D drug under section 1927 (or, if not reported by such manufacturer under section 1927, as reported by such manufacturer to the Secretary pursuant to the agreement under section 1193(a)) for such biological product, with respect to each of the calendar quarters of the price applicability period that would have applied but for this subsection; exceeds
616 115.3 - 115.5 [SEC. 11002.(a)(1)(C)] (f)(4)(B)(i)(I)(bb) in the initial price applicability year that would have applied but for a delay under
617 115.6 - 115.11 [SEC. 11002.(a)(1)(C)] (f)(4)(B)(i)(I)(bb)(AA) paragraph (2)(A), the maximum fair price negotiated under section 1194 for such biological product under such agreement; or
619 115.12 - 115.16 [SEC. 11002.(a)(1)(C)] (f)(4)(B)(i)(I)(bb)(BB) paragraph (2)(B)(iii), such maximum fair price, increased as described in section 1195(b)(1)(A); and
621 115.17 - 115.21 [SEC. 11002.(a)(1)(C)] (f)(4)(B)(i)(II) the number of units dispensed under part D of title XVIII for such covered part D drug during each such calendar quarter of such price applicability period; and
622 115.22 - 115.25 [SEC. 11002.(a)(1)(C)] (f)(4)(B)(ii) in the case of a biological product for which payment may be made under part B of title XVIII, that is the sum of the products of
623 116.1 - 116.2 [SEC. 11002.(a)(1)(C)] (f)(4)(B)(ii)(I) 80 percent of the amount by which
624 116.3 - 116.9 [SEC. 11002.(a)(1)(C)] (f)(4)(B)(ii)(I)(aa) the payment amount for such biological product under section 1847A(b), with respect to each of the calendar quarters of the price applicability period that would have applied but for this subsection; exceeds
625 116.10 - 116.12 [SEC. 11002.(a)(1)(C)] (f)(4)(B)(ii)(I)(bb) in the initial price applicability year that would have applied but for a delay under
626 116.13 - 116.18 [SEC. 11002.(a)(1)(C)] (f)(4)(B)(ii)(I)(bb)(AA) paragraph (2)(A), the maximum fair price negotiated under section 1194 for such biological product under such agreement; or
628 116.19 - 116.23 [SEC. 11002.(a)(1)(C)] (f)(4)(B)(ii)(I)(bb)(BB) paragraph (2)(B)(iii), such maximum fair price, increased as described in section 1195(b)(1)(A); and
630 116.24 - 117.8 [SEC. 11002.(a)(1)(C)] (f)(4)(B)(ii)(II) the number of units (excluding units that are packaged into the payment amount for an item or service and are not separately payable under such part B) of the billing and payment code of such biological product administered or furnished under such part B during each such calendar quarter of such price applicability period.
631 117.9 - 117.11 [SEC. 11002.(a)(1)(C)] (f)(4)(C) SPECIAL RULE FOR DELAYED BIOLOGICAL PRODUCTS THAT ARE LONG-MONOPOLY DRUGS.
632 117.12 - 117.24 [SEC. 11002.(a)(1)(C)] (f)(4)(C)(i) IN GENERAL. In the case of a biological product with respect to which a rebate is required to be paid under this paragraph, if such biological product qualifies as a long-monopoly drug (as defined in section 1194(c)(5)) at the time of its inclusion on the list published under subsection (a), in determining the amount of the rebate for such biological product under subparagraph (B), the amount described in clause (ii) shall be substituted for the maximum fair price described in clause (i)(I) or (ii)(I) of such subparagraph (B), as applicable.
634 118.1 - 118.19 [SEC. 11002.(a)(1)(C)] (f)(4)(C)(ii) AMOUNT DESCRIBED. The amount described in this clause is an amount equal to 65 percent of the average non-Federal average manufacturer price for the biological product for 2021 (or, in the case that there is not an average non-Federal average manufacturer price available for such biological product for 2021, for the first full year following the market entry for such biological product), increased by the percentage increase in the consumer price index for all urban consumers (all items; United States city average) from September 2021 (or December of such first full year following the market entry), as applicable, to September of the year prior to the selected drug publication date with respect to the initial price applicability year that would have applied but for this subsection.
635 118.20 - 118.22 [SEC. 11002.(a)(1)(C)] (f)(4)(D) REBATE DEPOSITS. Amounts paid as rebates under this paragraph shall be deposited into
636 118.23 - 119.2 [SEC. 11002.(a)(1)(C)] (f)(4)(D)(i) in the case payment is made for such biological product under part B of title XVIII, the Federal Supplementary Medical Insurance Trust Fund established under section 1841; and
637 119.3 - 119.7 [SEC. 11002.(a)(1)(C)] (f)(4)(D)(ii) in the case such biological product is a covered part D drug (as defined in section 1860D–2(e)), the Medicare Prescription Drug Account under section 1860D–16 in such Trust Fund.
638 119.8 - 119.11 [SEC. 11002.(a)(1)(C)] (f)(5) DEFINITIONS OF BIOSIMILAR BIOLOGICAL PRODUCT. In this subsection, the term ‘biosimilar biological product’ has the meaning given such term in section 1847A(c)(6).’’;
639 119.12 - 119.12 SEC. 11002.(a)(2) in section 1193(a)(4)
640 119.13 - 119.15 SEC. 11002.(a)(2)(A) in the matter preceding subparagraph (A), by inserting ‘‘, and for section 1192(f),’’ after ‘‘section 1194(f))’’;
642 119.16 - 119.17 SEC. 11002.(a)(2)(B) in subparagraph (A), by striking ‘‘and’’ at the end;
643 119.18 - 119.19 SEC. 11002.(a)(2)(C) by adding at the end the following new subparagraph:
644 119.20 - 119.22 [SEC. 11002.(a)(2)(C)] (C) information that the Secretary requires to carry out section 1192(f), including rebates under paragraph (4) of such section; and’’;
645 119.23 - 119.25 SEC. 11002.(a)(3) in section 1196(a)(7), by striking ‘‘section 1192(d)(2)(B)’’ and inserting ‘‘subsections (d)(2)(B) and (f)(1)(C) of section 1192’’;
646 120.1 - 120.1 SEC. 11002.(a)(4) in section 1197
647 120.2 - 120.4 SEC. 11002.(a)(4)(A) by redesignating subsections (b), (c), and (d) as subsections (c), (d), and (e), respectively; and
648 120.5 - 120.6 SEC. 11002.(a)(4)(B) by inserting after subsection (a) the following new subsection:
649 120.7 - 120.12 [SEC. 11002.(a)(4)(B)] (b) VIOLATIONS RELATING TO PROVIDING REBATES. Any manufacturer that fails to comply with the rebate requirements under section 1192(f)(4) shall be subject to a civil monetary penalty equal to 10 times the amount of the rebate the manufacturer failed to pay under such section.’’; and
650 120.13 - 120.14 SEC. 11002.(a)(5) in section 1198(b)(2), by inserting ‘‘the application of section 1192(f),’’ after ‘‘section 1192(e)’’.
651 120.15 - 120.20 SEC. 11002.(b) CONFORMING AMENDMENTS FOR DISCLOSURE OF CERTAIN INFORMATION. Section 1927(b)(3)(D)(i) of the Social Security Act (42 U.S.C. 1396r–8(b)(3)(D)(i)) is amended by striking ‘‘or to carry out section 1847B’’ and inserting ‘‘or to carry out section 1847B or section 1192(f), including rebates under paragraph (4) of such section’’.
652 120.21 - 120.25 SEC. 11002.(c) IMPLEMENTATION FOR 2026 THROUGH 2028. The Secretary of Health and Human Services shall implement this section, including the amendments made by this section, for 2026, 2027, and 2028 by program instruction or other forms of program guidance.
653 121.1 - 121.2 TITLE I Subtitle B PART 1 SEC. 11003. EXCISE TAX IMPOSED ON DRUG MANUFACTURERS DURING NONCOMPLIANCE PERIODS.
654 121.3 - 121.5 SEC. 11003.(a) IN GENERAL. Subtitle D of the Internal Revenue Code of 1986 is amended by adding at the end the following new chapter:
655 121.6 - 121.6 [SEC. 11003.(a)] CHAPTER 50 A DESIGNATED DRUGS
656 121.7 - 121.8 [SEC. 11003.(a)] CHAPTER 50 SEC. 5000D. DESIGNATED DRUGS DURING NONCOMPLIANCE PERIODS.
657 121.9 - 121.13 [SEC. 11003.(a)] SEC. 5000D.(a) IN GENERAL. There is hereby imposed on the sale by the manufacturer, producer, or importer of any designated drug during a day described in subsection (b) a tax in an amount such that the applicable percentage is equal to the ratio of
658 121.14 - 121.14 [SEC. 11003.(a)] SEC. 5000D.(a)(1) such tax, divided by
659 121.15 - 121.16 [SEC. 11003.(a)] SEC. 5000D.(a)(2) the sum of such tax and the price for which so sold.
660 121.17 - 121.19 [SEC. 11003.(a)] SEC. 5000D.(b) NONCOMPLIANCE PERIODS. A day is described in this subsection with respect to a designated drug if it is a day during one of the following periods:
661 121.20 - 121.25 [SEC. 11003.(a)] SEC. 5000D.(b)(1) The period beginning on the March 1st (or, in the case of initial price applicability year 2026, the October 2nd) immediately following the date on which such drug is included on the list published under section 1192(a) of the Social Security Act and ending on the earlier of
662 122.1 - 122.4 [SEC. 11003.(a)] SEC. 5000D.(b)(1)(A) the first date on which the manufacturer of such designated drug has in place an agreement described in section 1193(a) of such Act with respect to such drug, or
663 122.5 - 122.8 [SEC. 11003.(a)] SEC. 5000D.(b)(1)(B) the date that the Secretary of Health and Human Services has made a determination described in section 1192(c)(1) of such Act with respect to such designated drug.
664 122.9 - 122.14 [SEC. 11003.(a)] SEC. 5000D.(b)(2) The period beginning on the November 2nd immediately following the March 1st described in paragraph (1) (or, in the case of initial price applicability year 2026, the August 2nd immediately following the October 2nd described in such paragraph) and ending on the earlier of
665 122.15 - 122.20 [SEC. 11003.(a)] SEC. 5000D.(b)(2)(A) the first date on which the manufacturer of such designated drug and the Secretary of Health and Human Services have agreed to a maximum fair price under an agreement described in section 1193(a) of the Social Security Act, or
666 122.21 - 122.24 [SEC. 11003.(a)] SEC. 5000D.(b)(2)(B) the date that the Secretary of Health and Human Services has made a determination described in section 1192(c)(1) of such Act with respect to such designated drug.
667 123.1 - 123.10 [SEC. 11003.(a)] SEC. 5000D.(b)(3) In the case of any designated drug which is a selected drug (as defined in section 1192(c) of the Social Security Act) that the Secretary of Health and Human Services has selected for renegotiation under section 1194(f) of such Act, the period beginning on the November 2nd of the year that begins 2 years prior to the first initial price applicability year of the price applicability period for which the maximum fair price established pursuant to such renegotiation applies and ending on the earlier of
668 123.11 - 123.14 [SEC. 11003.(a)] SEC. 5000D.(b)(3)(A) the first date on which the manufacturer of such designated drug has agreed to a renegotiated maximum fair price under such agreement, or
669 123.15 - 123.18 [SEC. 11003.(a)] SEC. 5000D.(b)(3)(B) the date that the Secretary of Health and Human Services has made a determination described in section 1192(c)(1) of such Act with respect to such designated drug.
670 123.19 - 123.25 [SEC. 11003.(a)] SEC. 5000D.(b)(4) With respect to information that is required to be submitted to the Secretary of Health and Human Services under an agreement described in section 1193(a) of the Social Security Act, the period beginning on the date on which such Secretary certifies that such information is overdue and ending on the date that such information is so submitted.
671 124.1 - 124.1 [SEC. 11003.(a)] SEC. 5000D.(c) SUSPENSION OF TAX.
672 124.2 - 124.5 [SEC. 11003.(a)] SEC. 5000D.(c)(1) IN GENERAL. A day shall not be taken into account as a day during a period described in subsection (b) if such day is also a day during the period
673 124.6 - 124.6 [SEC. 11003.(a)] SEC. 5000D.(c)(1)(A) beginning on the first date on which
674 124.7 - 124.10 [SEC. 11003.(a)] SEC. 5000D.(c)(1)(A)(i) the notice of terminations of all applicable agreements of the manufacturer have been received by the Secretary of Health and Human Services, and
675 124.11 - 124.14 [SEC. 11003.(a)] SEC. 5000D.(c)(1)(A)(ii) none of the drugs of the manufacturer of the designated drug are covered by an agreement under section 1860D-14A or 1860D-14C of the Social Security Act, and
676 124.15 - 124.16 [SEC. 11003.(a)] SEC. 5000D.(c)(1)(B) ending on the last day of February following the earlier of
677 124.17 - 124.20 [SEC. 11003.(a)] SEC. 5000D.(c)(1)(B)(i) the first day after the date described in subparagraph (A) on which the manufacturer enters into any subsequent applicable agreement, or
678 124.21 - 124.25 [SEC. 11003.(a)] SEC. 5000D.(c)(1)(B)(ii) the first date any drug of the manufacturer of the designated drug is covered by an agreement under section 1860D14A or 1860D-14C of the Social Security Act.
679 125.1 - 125.3 [SEC. 11003.(a)] SEC. 5000D.(c)(2) APPLICABLE AGREEMENT. For purposes of this subsection, the term ‘applicable agreement’ means the following:
680 125.4 - 125.4 [SEC. 11003.(a)] SEC. 5000D.(c)(2)(A) An agreement under
681 125.5 - 125.7 [SEC. 11003.(a)] SEC. 5000D.(c)(2)(A)(i) the Medicare coverage gap discount program under section 1860D-14A of the Social Security Act, or
682 125.8 - 125.9 [SEC. 11003.(a)] SEC. 5000D.(c)(2)(A)(ii) the manufacturer discount program under section 1860D-14C of such Act.
683 125.10 - 125.11 [SEC. 11003.(a)] SEC. 5000D.(c)(2)(B) A rebate agreement described in section 1927(b) of such Act.
684 125.12 - 125.13 [SEC. 11003.(a)] SEC. 5000D.(d) APPLICABLE PERCENTAGE. For purposes of this section, the term ‘applicable percentage’ means
685 125.14 - 125.16 [SEC. 11003.(a)] SEC. 5000D.(d)(1) in the case of sales of a designated drug during the first 90 days described in subsection (b) with respect to such drug, 65 percent,
686 125.17 - 125.19 [SEC. 11003.(a)] SEC. 5000D.(d)(2) in the case of sales of such drug during the 91st day through the 180th day described in subsection (b) with respect to such drug, 75 percent,
687 125.20 - 125.22 [SEC. 11003.(a)] SEC. 5000D.(d)(3) in the case of sales of such drug during the 181st day through the 270th day described in subsection (b) with respect to such drug, 85 percent, and
688 125.23 - 125.24 [SEC. 11003.(a)] SEC. 5000D.(d)(4) in the case of sales of such drug during any subsequent day, 95 percent.
689 125.25 - 125.25 [SEC. 11003.(a)] SEC. 5000D.(e) DEFINITIONS. For purposes of this section
690 126.1 - 126.7 [SEC. 11003.(a)] SEC. 5000D.(e)(1) DESIGNATED DRUG. The term ‘designated drug’ means any negotiation-eligible drug (as defined in section 1192(d) of the Social Security Act) included on the list published under section 1192(a) of such Act which is manufactured or produced in the United States or entered into the United States for consumption, use, or warehousing.
691 126.8 - 126.10 [SEC. 11003.(a)] SEC. 5000D.(e)(2) UNITED STATES. The term ‘United States’ has the meaning given such term by section 4612(a)(4).
692 126.11 - 126.14 [SEC. 11003.(a)] SEC. 5000D.(e)(3) OTHER TERMS. The terms ‘initial price applicability year’, ‘price applicability period’, and ‘maximum fair price’ have the meaning given such terms in section 1191 of the Social Security Act.
693 126.15 - 126.15 [SEC. 11003.(a)] SEC. 5000D.(f) SPECIAL RULES.
694 126.16 - 126.19 [SEC. 11003.(a)] SEC. 5000D.(f)(1) COORDINATION WITH RULES FOR POSSESSIONS OF THE UNITED STATES. Rules similar to the rules of paragraphs (2) and (4) of section 4132(c) shall apply for purposes of this section.
695 126.20 - 126.24 [SEC. 11003.(a)] SEC. 5000D.(f)(2) ANTI-ABUSE RULE. In the case of a sale which was timed for the purpose of avoiding the tax imposed by this section, the Secretary may treat such sale as occurring during a day described in subsection (b).
697 127.1 - 127.3 [SEC. 11003.(a)] SEC. 5000D.(g) EXPORTS. Rules similar to the rules of section 4662(e) (other than section 4662(e)(2)(A)(ii)(II)) shall apply for purposes of this chapter.
698 127.4 - 127.6 [SEC. 11003.(a)] SEC. 5000D.(h) REGULATIONS. The Secretary shall prescribe such regulations and other guidance as may be necessary to carry out this section.’’.
699 127.7 - 127.9 SEC. 11003.(b) NO DEDUCTION FOR EXCISE TAX PAYMENTS. Section 275(a)(6) of the Internal Revenue Code of 1986 is amended by inserting ‘‘50A,’’ after ‘‘46,’’.
701 127.10 - 127.12 SEC. 11003.(c) CLERICAL AMENDMENT. The table of chapters for subtitle D of the Internal Revenue Code of 1986 is amended by adding at the end the following new item:
702 127.13 - 127.15 SEC. 11003.(d) EFFECTIVE DATE. The amendments made by this section shall apply to sales after the date of the enactment of this Act.
703 127.16 - 127.22 TITLE I Subtitle B PART 1 SEC. 11004. FUNDING. In addition to amounts otherwise available, there is appropriated to the Centers for Medicare & Medicaid Services, out of any money in the Treasury not otherwise appropriated, $3,000,000,000 for fiscal year 2022, to remain available until expended, to carry out the provisions of, including the amendments made by, this part.
704 128.1 - 128.2 TITLE I Subtitle B PART 2 PRESCRIPTION DRUG INFLATION REBATES
705 128.3 - 128.4 TITLE I Subtitle B PART 2 SEC. 11101. MEDICARE PART B REBATE BY MANUFACTURERS.
706 128.5 - 128.8 SEC. 11101.(a) IN GENERAL. Section 1847A of the Social Security Act (42 U.S.C. 1395w–3a) is amended by redesignating subsection (i) as subsection (j) and by inserting after subsection (h) the following subsection:
707 128.9 - 128.11 [SEC. 11101.(a)] (i) REBATE BY MANUFACTURERS FOR SINGLE SOURCE DRUGS AND BIOLOGICALS WITH PRICES INCREASING FASTER THAN INFLATION.
708 128.12 - 128.12 [SEC. 11101.(a)] (i)(1) REQUIREMENTS.
709 128.13 - 128.19 [SEC. 11101.(a)] (i)(1)(A) SECRETARIAL PROVISION OF INFORMATION. Not later than 6 months after the end of each calendar quarter beginning on or after January 1, 2023, the Secretary shall, for each part B rebatable drug, report to each manufacturer of such part B rebatable drug the following for such calendar quarter:
710 128.20 - 128.24 [SEC. 11101.(a)] (i)(1)(A)(i) Information on the total number of units of the billing and payment code described in subparagraph (A)(i) of paragraph (3) with respect to such drug and calendar quarter.
711 128.25 - 129.3 [SEC. 11101.(a)] (i)(1)(A)(ii) Information on the amount (if any) of the excess average sales price increase described in subparagraph (A)(ii) of such paragraph for such drug and calendar quarter.
712 129.4 - 129.6 [SEC. 11101.(a)] (i)(1)(A)(iii) The rebate amount specified under such paragraph for such part B rebatable drug and calendar quarter.
713 129.7 - 129.16 [SEC. 11101.(a)] (i)(1)(B) MANUFACTURER REQUIREMENT. For each calendar quarter beginning on or after January 1, 2023, the manufacturer of a part B rebatable drug shall, for such drug, not later than 30 days after the date of receipt from the Secretary of the information described in subparagraph (A) for such calendar quarter, provide to the Secretary a rebate that is equal to the amount specified in paragraph (3) for such drug for such calendar quarter.
714 129.17 - 129.22 [SEC. 11101.(a)] (i)(1)(C) TRANSITION RULE FOR REPORTING. The Secretary may, for each part B rebatable drug, delay the timeframe for reporting the information described in subparagraph (A) for calendar quarters beginning in 2023 and 2024 until not later than September 30, 2025.
715 129.23 - 129.23 [SEC. 11101.(a)] (i)(2) PART B REBATABLE DRUG DEFINED.
716 129.24 - 130.9 [SEC. 11101.(a)] (i)(2)(A) IN GENERAL. In this subsection, the term ‘part B rebatable drug’ means a single source drug or biological (as defined in subparagraph (D) of subsection (c)(6)), including a biosimilar biological product (as defined in subparagraph (H) of such subsection) but excluding a qualifying biosimilar biological product (as defined in subsection (b)(8)(B)(iii)), for which payment is made under this part, except such term shall not include such a drug or biological
717 130.10 - 130.15 [SEC. 11101.(a)] (i)(2)(A)(i) if, as determined by the Secretary, the average total allowed charges for such drug or biological under this part for a year per individual that uses such a drug or biological are less than, subject to subparagraph (B), $100; or
718 130.16 - 130.17 [SEC. 11101.(a)] (i)(2)(A)(ii) that is a vaccine described in subparagraph (A) or (B) of section 1861(s)(10).
719 130.18 - 130.19 [SEC. 11101.(a)] (i)(2)(B) INCREASE. The dollar amount applied under subparagraph (A)(i)
720 130.20 - 131.2 [SEC. 11101.(a)] (i)(2)(B)(i) for 2024, shall be the dollar amount specified under such subparagraph for 2023, increased by the percentage increase in the consumer price index for all urban consumers (United States city average) for the 12-month period ending with June of the previous year; and
721 131.3 - 131.10 [SEC. 11101.(a)] (i)(2)(B)(ii) for a subsequent year, shall be the dollar amount specified in this clause (or clause (i)) for the previous year (without application of subparagraph (C)), increased by the percentage increase in the consumer price index for all urban consumers (United States city average) for the 12-month period ending with June of the previous year.
722 131.11 - 131.14 [SEC. 11101.(a)] (i)(2)(C) ROUNDING. Any dollar amount determined under subparagraph (B) that is not a multiple of $10 shall be rounded to the nearest multiple of $10.
723 131.15 - 131.15 [SEC. 11101.(a)] (i)(3) REBATE AMOUNT.
724 131.16 - 131.22 [SEC. 11101.(a)] (i)(3)(A) IN GENERAL. For purposes of paragraph (1), the amount specified in this paragraph for a part B rebatable drug assigned to a billing and payment code for a calendar quarter is, subject to subparagraphs (B) and (G) and paragraph (4), the estimated amount equal to the product of
725 131.23 - 131.25 [SEC. 11101.(a)] (i)(3)(A)(i) the total number of units determined under subparagraph (B) for the billing and payment code of such drug; and
726 132.1 - 132.1 [SEC. 11101.(a)] (i)(3)(A)(ii) the amount (if any) by which
727 132.2 - 132.2 [SEC. 11101.(a)] (i)(3)(A)(ii)(I) the amount equal to
728 132.3 - 132.9 [SEC. 11101.(a)] (i)(3)(A)(ii)(I)(aa) in the case of a part B rebatable drug described in paragraph (1)(B) of subsection (b), 106 percent of the amount determined under paragraph (4) of such section for such drug during the calendar quarter; or
729 132.10 - 132.15 [SEC. 11101.(a)] (i)(3)(A)(ii)(I)(bb) in the case of a part B rebatable drug described in paragraph (1)(C) of such subsection, the payment amount under such paragraph for such drug during the calendar quarter; exceeds
730 132.16 - 132.20 [SEC. 11101.(a)] (i)(3)(A)(ii)(II) the inflation-adjusted payment amount determined under subparagraph (C) for such part B rebatable drug during the calendar quarter.
731 132.21 - 133.2 [SEC. 11101.(a)] (i)(3)(B) TOTAL NUMBER OF UNITS. For purposes of subparagraph (A)(i), the total number of units for the billing and payment code with respect to a part B rebatable drug furnished during a calendar quarter described in subparagraph (A) is equal to
732 133.3 - 133.5 [SEC. 11101.(a)] (i)(3)(B)(i) the number of units for the billing and payment code of such drug furnished during such calendar quarter, minus
733 133.6 - 133.8 [SEC. 11101.(a)] (i)(3)(B)(ii) the number of units for such billing and payment code of such drug furnished during such calendar quarter
734 133.9 - 133.13 [SEC. 11101.(a)] (i)(3)(B)(ii)(I) with respect to which the manufacturer provides a discount under the program under section 340B of the Public Health Service Act or a rebate under section 1927; or
735 133.14 - 133.16 [SEC. 11101.(a)] (i)(3)(B)(ii)(II) that are packaged into the payment amount for an item or service and are not separately payable.
736 133.17 - 133.21 [SEC. 11101.(a)] (i)(3)(C) DETERMINATION OF INFLATION-ADJUSTED PAYMENT AMOUNT. The inflation-adjusted payment amount determined under this subparagraph for a part B rebatable drug for a calendar quarter is
737 133.22 - 133.25 [SEC. 11101.(a)] (i)(3)(C)(i) the payment amount for the billing and payment code for such drug in the payment amount benchmark quarter (as defined in subparagraph (D)); increased by
738 134.1 - 134.5 [SEC. 11101.(a)] (i)(3)(C)(ii) the percentage by which the rebate period CPI–U (as defined in subparagraph (F)) for the calendar quarter exceeds the benchmark period CPI–U (as defined in subparagraph (E)).
740 134.6 - 134.9 [SEC. 11101.(a)] (i)(3)(D) PAYMENT AMOUNT BENCHMARK QUARTER. The term ‘payment amount benchmark quarter’ means the calendar quarter beginning July 1, 2021.
741 134.10 - 134.13 [SEC. 11101.(a)] (i)(3)(E) BENCHMARK PERIOD CPI–U. The term ‘benchmark period CPI–U’ means the consumer price index for all urban consumers (United States city average) for January 2021.
742 134.14 - 134.22 [SEC. 11101.(a)] (i)(3)(F) REBATE PERIOD CPI–U. The term ‘rebate period CPI–U’ means, with respect to a calendar quarter described in subparagraph (C), the greater of the benchmark period CPI–U and the consumer price index for all urban consumers (United States city average) for the first month of the calendar quarter that is two calendar quarters prior to such described calendar quarter.
743 134.23 - 135.3 [SEC. 11101.(a)] (i)(3)(G) REDUCTION OR WAIVER FOR SHORTAGES AND SEVERE SUPPLY CHAIN DISRUPTIONS. The Secretary shall reduce or waive the amount under subparagraph (A) with respect to a part B rebatable drug and a calendar quarter
744 135.4 - 135.9 [SEC. 11101.(a)] (i)(3)(G)(i) in the case of a part B rebatable drug that is described as currently in shortage on the shortage list in effect under section 506E of the Federal Food, Drug, and Cosmetic Act at any point during the calendar quarter; or
745 135.10 - 135.15 [SEC. 11101.(a)] (i)(3)(G)(ii) in the case of a biosimilar biological product, when the Secretary determines there is a severe supply chain disruption during the calendar quarter, such as that caused by a natural disaster or other unique or unexpected event.
746 135.16 - 135.17 [SEC. 11101.(a)] (i)(4) SPECIAL TREATMENT OF CERTAIN DRUGS AND EXEMPTION.
747 135.18 - 136.7 [SEC. 11101.(a)] (i)(4)(A) SUBSEQUENTLY APPROVED DRUGS. In the case of a part B rebatable drug first approved or licensed by the Food and Drug Administration after December 1, 2020, clause (i) of paragraph (3)(C) shall be applied as if the term ‘payment amount benchmark quarter’ were defined under paragraph (3)(D) as the third full calendar quarter after the day on which the drug was first marketed and clause (ii) of paragraph (3)(C) shall be applied as if the term ‘benchmark period CPI–U’ were defined under paragraph (3)(E) as if the reference to ‘January 2021’ under such paragraph were a reference to ‘the first month of the first full calendar quarter after the day on which the drug was first marketed’.
750 136.8 - 136.17 [SEC. 11101.(a)] (i)(4)(B) TIMELINE FOR PROVISION OF REBATES FOR SUBSEQUENTLY APPROVED DRUGS. In the case of a part B rebatable drug first approved or licensed by the Food and Drug Administration after December 1, 2020, paragraph (1)(B) shall be applied as if the reference to ‘January 1, 2023’ under such paragraph were a reference to ‘the later of the 6th full calendar quarter after the day on which the drug was first marketed or January 1, 2023’.
751 136.18 - 137.12 [SEC. 11101.(a)] (i)(4)(C) SELECTED DRUGS. In the case of a part B rebatable drug that is a selected drug (as defined in section 1192(c)) with respect to a price applicability period (as defined in section 1191(b)(2)), in the case such drug is no longer considered to be a selected drug under section 1192(c), for each applicable period (as defined under subsection (g)(7)) beginning after the price applicability period with respect to such drug, clause (i) of paragraph (3)(C) shall be applied as if the term ‘payment amount benchmark quarter’ were defined under paragraph (3)(D) as the calendar quarter beginning January 1 of the last year during such price applicability period with respect to such selected drug and clause (ii) of paragraph (3)(C) shall be applied as if the term ‘benchmark period CPI–U’ were defined under paragraph (3)(E) as if the reference to ‘January 2021’ under such paragraph were a reference to ‘the July of the year preceding such last year’.
752 137.13 - 137.21 [SEC. 11101.(a)] (i)(5) APPLICATION TO BENEFICIARY COINSURANCE. In the case of a part B rebatable drug furnished on or after April 1, 2023, if the payment amount described in paragraph (3)(A)(ii)(I) (or, in the case of a part B rebatable drug that is a selected drug (as defined in section 1192(c)), the payment amount described in subsection (b)(1)(B) for such drug) for a calendar quarter exceeds the inflation adjusted payment for such quarter
753 137.22 - 138.3 [SEC. 11101.(a)] (i)(5)(A) in computing the amount of any coinsurance applicable under this part to an individual to whom such drug is furnished, the computation of such coinsurance shall be equal to 20 percent of the inflation-adjusted payment amount determined under paragraph (3)(C) for such part B rebatable drug; and
754 138.4 - 138.9 [SEC. 11101.(a)] (i)(5)(B) the amount of such coinsurance for such calendar quarter, as computed under subparagraph (A), shall be applied as a percent, as determined by the Secretary, to the payment amount that would otherwise apply under subparagraphs (B) or (C) of subsection (b)(1).
755 138.10 - 138.13 [SEC. 11101.(a)] (i)(6) REBATE DEPOSITS. Amounts paid as rebates under paragraph (1)(B) shall be deposited into the Federal Supplementary Medical Insurance Trust Fund established under section 1841.
756 138.14 - 139.3 [SEC. 11101.(a)] (i)(7) CIVIL MONEY PENALTY. If a manufacturer of a part B rebatable drug has failed to comply with the requirements under paragraph (1)(B) for such drug for a calendar quarter, the manufacturer shall be subject to, in accordance with a process established by the Secretary pursuant to regulations, a civil money penalty in an amount equal to at least 125 percent of the amount specified in paragraph (3) for such drug for such calendar quarter. The provisions of section 1128A (other than subsections (a) (with respect to amounts of penalties or additional assessments) and (b)) shall apply to a civil money penalty under this paragraph in the same manner as such provisions apply to a penalty or proceeding under section 1128A(a).
757 139.4 - 139.6 [SEC. 11101.(a)] (i)(8) LIMITATION ON ADMINISTRATIVE OR JUDICIAL REVIEW. There shall be no administrative or judicial review of any of the following:
758 139.7 - 139.8 [SEC. 11101.(a)] (i)(8)(A) The determination of units under this subsection.
759 139.9 - 139.10 [SEC. 11101.(a)] (i)(8)(B) The determination of whether a drug is a part B rebatable drug under this subsection.
760 139.11 - 139.12 [SEC. 11101.(a)] (i)(8)(C) The calculation of the rebate amount under this subsection.
761 139.13 - 139.14 [SEC. 11101.(a)] (i)(8)(D) The computation of coinsurance under paragraph (5) of this subsection.
762 139.15 - 139.16 [SEC. 11101.(a)] (i)(8)(E) The computation of amounts paid under section 1833(a)(1)(EE).’’.
763 139.17 - 139.19 SEC. 11101.(b) AMOUNTS PAYABLE; COST-SHARING. Section 1833 of the Social Security Act (42 U.S.C. 1395l) is amended
764 139.20 - 139.20 SEC. 11101.(b)(1) in subsection (a)(1)
765 139.21 - 139.23 SEC. 11101.(b)(1)(A) in subparagraph (G), by inserting ‘‘, subject to subsection (i)(9),’’ after ‘‘the amounts paid’’;
766 140.1 - 140.3 SEC. 11101.(b)(1)(B) in subparagraph (S), by striking ‘‘with respect to’’ and inserting ‘‘subject to subparagraph (EE), with respect to’’;
767 140.4 - 140.5 SEC. 11101.(b)(1)(C) by striking ‘‘and (DD)’’ and inserting (DD)’’; and
769 140.6 - 140.24 SEC. 11101.(b)(1)(D) by inserting before the semicolon at the end the following: ‘‘, and (EE) with respect to a part B rebatable drug (as defined in paragraph (2) of section 1847A(i)) furnished on or after April 1, 2023, for which the payment amount for a calendar quarter under paragraph (3)(A)(ii)(I) of such section (or, in the case of a part B rebatable drug that is a selected drug (as defined in section 1192(c) for which, the payment amount described in section 1847A(b)(1)(B)) for such drug for such quarter exceeds the inflation-adjusted payment under paragraph (3)(A)(ii)(II) of such section for such quarter, the amounts paid shall be equal to the percent of the payment amount under paragraph (3)(A)(ii)(I) of such section or section 1847A(b)(1)(B), as applicable, that equals the difference between (i) 100 percent, and (ii) the percent applied under section 1847A(i)(5)(B)’’;
773 141.1 - 141.2 SEC. 11101.(b)(2) in subsection (i), by adding at the end the following new paragraph:
774 141.3 - 141.14 [SEC. 11101.(b)(2)] (9) In the case of a part B rebatable drug (as defined in paragraph (2) of section 1847A(i)) for which payment under this subsection is not packaged into a payment for a service furnished on or after April 1, 2023, under the revised payment system under this subsection, in lieu of calculation of coinsurance and the amount of payment otherwise applicable under this subsection, the provisions of section 1847A(i)(5) and paragraph (1)(EE) of subsection (a), shall, as determined appropriate by the Secretary, apply under this subsection in the same manner as such provisions of section 1847A(i)(5) and subsection (a) apply under such section and subsection.’’; and
775 141.15 - 141.16 SEC. 11101.(b)(3) in subsection (t)(8), by adding at the end the following new subparagraph:
776 141.17 - 142.14 [SEC. 11101.(b)(3)] (F) PART B REBATABLE DRUGS. In the case of a part B rebatable drug (as defined in paragraph (2) of section 1847A(i), except if such drug does not have a copayment amount as a result of application of subparagraph (E)) for which payment under this part is not packaged into a payment for a covered OPD service (or group of services) furnished on or after April 1, 2023, and the payment for such drug under this subsection is the same as the amount for a calendar quarter under paragraph (3)(A)(ii)(I) of section 1847A(i), under the system under this subsection, in lieu of calculation of the copayment amount and the amount of payment otherwise applicable under this subsection (other than the application of the limitation described in subparagraph (C)), the provisions of section 1847A(i)(5) and paragraph (1)(EE) of subsection (a), shall, as determined appropriate by the Secretary, apply under this subsection in the same manner as such provisions of section 1847A(i)(5) and subsection (a) apply under such section and subsection.’’.
777 142.15 - 142.15 SEC. 11101.(c) CONFORMING AMENDMENTS.
778 142.16 - 142.19 SEC. 11101.(c)(1) TO PART B ASP CALCULATION. Section 1847A(c)(3) of the Social Security Act (42 U.S.C. 1395w–3a(c)(3)) is amended by inserting ‘‘subsection (i) or’’ before ‘‘section 1927’’.
780 142.20 - 142.24 SEC. 11101.(c)(2) EXCLUDING PART B DRUG INFLATION REBATE FROM BEST PRICE. Section 1927(c)(1)(C)(ii)(I) of the Social Security Act (42 U.S.C. 1396r–8(c)(1)(C)(ii)(I)) is amended by inserting ‘‘or section 1847A(i)’’ after ‘‘this section’’.
781 143.1 - 143.5 SEC. 11101.(c)(3) COORDINATION WITH MEDICAID REBATE INFORMATION DISCLOSURE. Section 1927(b)(3)(D)(i) of the Social Security Act (42 U.S.C. 1396r– 8(b)(3)(D)(i)) is amended by inserting ‘‘and the rebate’’ after ‘‘the payment amount’’.
782 143.6 - 143.10 SEC. 11101.(c)(4) EXCLUDING PART B DRUG INFLATION REBATES FROM AVERAGE MANUFACTURER PRICE. Section 1927(k)(1)(B)(i) of the Social Security Act (42 U.S.C. 1396r–8(k)(1)(B)(i)), as amended by section 11001(b)(3), is amended
783 143.11 - 143.12 SEC. 11101.(c)(4)(A) in subclause (V), by striking ‘‘and’’ at the end;
784 143.13 - 143.14 SEC. 11101.(c)(4)(B) in subclause (VI), by striking the period at the end and inserting a semicolon; and
785 143.15 - 143.16 SEC. 11101.(c)(4)(C) by adding at the end the following new subclause:
786 143.17 - 143.18 [SEC. 11101.(c)(4)(C)] (VII) rebates paid by manufacturers under section 1847A(i); and’’.
787 143.19 - 144.3 SEC. 11101.(d) FUNDING. In addition to amounts otherwise available, there are appropriated to the Centers for Medicare & Medicaid Services, out of any money in the Treasury not otherwise appropriated, $80,000,000 for fiscal year 2022, including $12,500,000 to carry out the provisions of, including the amendments made by, this section in fiscal year 2022, and $7,500,000 to carry out the provisions of, including the amendments made by, this section in each of fiscal years 2023 through 2031, to remain available until expended.
788 144.4 - 144.5 TITLE I Subtitle B PART 2 SEC. 11102. MEDICARE PART D REBATE BY MANUFACTURERS.
789 144.6 - 144.8 SEC. 11102.(a) IN GENERAL. Part D of title XVIII of the Social Security Act is amended by inserting after section 1860D– 14A (42 U.S.C. 1395w–114a) the following new section:
790 144.9 - 144.11 [SEC. 11102.(a)] SEC. 1860D–14B. MANUFACTURER REBATE FOR CERTAIN DRUGS WITH PRICES INCREASING FASTER THAN INFLATION.
791 144.12 - 144.12 [SEC. 11102.(a)] SEC. 1860D–14B.(a) REQUIREMENTS.
792 144.13 - 144.19 [SEC. 11102.(a)] SEC. 1860D–14B.(a)(1) SECRETARIAL PROVISION OF INFORMATION. Not later than 9 months after the end of each applicable period (as defined in subsection (g)(7)), subject to paragraph (3), the Secretary shall, for each part D rebatable drug, report to each manufacturer of such part D rebatable drug the following for such period:
793 144.20 - 144.23 [SEC. 11102.(a)] SEC. 1860D–14B.(a)(1)(A) The amount (if any) of the excess annual manufacturer price increase described in subsection (b)(1)(A)(ii) for each dosage form and strength with respect to such drug and period.
794 145.1 - 145.3 [SEC. 11102.(a)] SEC. 1860D–14B.(a)(1)(B) The rebate amount specified under subsection (b) for each dosage form and strength with respect to such drug and period.
795 145.4 - 145.13 [SEC. 11102.(a)] SEC. 1860D–14B.(a)(2) MANUFACTURER REQUIREMENTS. For each applicable period, the manufacturer of a part D rebatable drug, for each dosage form and strength with respect to such drug, not later than 30 days after the date of receipt from the Secretary of the information described in paragraph (1) for such period, shall provide to the Secretary a rebate that is equal to the amount specified in subsection (b) for such dosage form and strength with respect to such drug for such period.
796 145.14 - 145.20 [SEC. 11102.(a)] SEC. 1860D–14B.(a)(3) TRANSITION RULE FOR REPORTING. The Secretary may, for each rebatable covered part D drug, delay the timeframe for reporting the information and rebate amount described in subparagraphs (A) and (B) of such paragraph for the applicable periods beginning October 1, 2022, and October 1, 2023, until not later than December 31, 2025.
798 145.21 - 145.21 [SEC. 11102.(a)] SEC. 1860D–14B.(b) REBATE AMOUNT.
799 145.22 - 145.22 [SEC. 11102.(a)] SEC. 1860D–14B.(b)(1) IN GENERAL.
800 145.23 - 146.4 [SEC. 11102.(a)] SEC. 1860D–14B.(b)(1)(A) CALCULATION. For purposes of this section, the amount specified in this subsection for a dosage form and strength with respect to a part D rebatable drug and applicable period is, subject to subparagraph (C), paragraph (5)(B), and paragraph (6), the estimated amount equal to the product of
801 146.5 - 146.10 [SEC. 11102.(a)] SEC. 1860D–14B.(b)(1)(A)(i) subject to subparagraph (B) of this paragraph, the total number of units of such dosage form and strength for each rebatable covered part D drug dispensed under this part during the applicable period; and
802 146.11 - 146.11 [SEC. 11102.(a)] SEC. 1860D–14B.(b)(1)(A)(ii) the amount (if any) by which
803 146.12 - 146.16 [SEC. 11102.(a)] SEC. 1860D–14B.(b)(1)(A)(ii)(I) the annual manufacturer price (as determined in paragraph (2)) paid for such dosage form and strength with respect to such part D rebatable drug for the period; exceeds
804 146.17 - 146.21 [SEC. 11102.(a)] SEC. 1860D–14B.(b)(1)(A)(ii)(II) the inflation-adjusted payment amount determined under paragraph (3) for such dosage form and strength with respect to such part D rebatable drug for the period.
805 146.22 - 147.6 [SEC. 11102.(a)] SEC. 1860D–14B.(b)(1)(B) EXCLUDED UNITS. For purposes of subparagraph (A)(i), beginning with plan year 2026, the Secretary shall exclude from the total number of units for a dosage form and strength with respect to a part D rebatable drug, with respect to an applicable period, units of each dosage form and strength of such part D rebatable drug for which the manufacturer provides a discount under the program under section 340B of the Public Health Service Act.
806 147.7 - 147.12 [SEC. 11102.(a)] SEC. 1860D–14B.(b)(1)(C) REDUCTION OR WAIVER FOR SHORTAGES AND SEVERE SUPPLY CHAIN DISRUPTIONS. The Secretary shall reduce or waive the amount under subparagraph (A) with respect to a part D rebatable drug and an applicable period
807 147.13 - 147.18 [SEC. 11102.(a)] SEC. 1860D–14B.(b)(1)(C)(i) in the case of a part D rebatable drug that is described as currently in shortage on the shortage list in effect under section 506E of the Federal Food, Drug, and Cosmetic Act at any point during the applicable period;
808 147.19 - 148.3 [SEC. 11102.(a)] SEC. 1860D–14B.(b)(1)(C)(ii) in the case of a generic part D rebatable drug (described in subsection (g)(1)(C)(ii)) or a biosimilar (defined as a biological product licensed under section 351(k) of the Public Health Service Act), when the Secretary determines there is a severe supply chain disruption during the applicable period, such as that caused by a natural disaster or other unique or unexpected event; and
810 148.4 - 148.9 [SEC. 11102.(a)] SEC. 1860D–14B.(b)(1)(C)(iii) in the case of a generic Part D rebatable drug (as so described), if the Secretary determines that without such reduction or waiver, the drug is likely to be described as in shortage on such shortage list during a subsequent applicable period.
811 148.10 - 148.14 [SEC. 11102.(a)] SEC. 1860D–14B.(b)(2) DETERMINATION OF ANNUAL MANUFACTURER PRICE. The annual manufacturer price determined under this paragraph for a dosage form and strength, with respect to a part D rebatable drug and an applicable period, is the sum of the products of
812 148.15 - 148.19 [SEC. 11102.(a)] SEC. 1860D–14B.(b)(2)(A) the average manufacturer price (as defined in subsection (g)(6)) of such dosage form and strength, as calculated for a unit of such drug, with respect to each of the calendar quarters of such period; and
813 148.20 - 148.20 [SEC. 11102.(a)] SEC. 1860D–14B.(b)(2)(B) the ratio of
814 148.21 - 148.24 [SEC. 11102.(a)] SEC. 1860D–14B.(b)(2)(B)(i) the total number of units of such dosage form and strength reported under section 1927 with respect to each such calendar quarter of such period; to
815 149.1 - 149.4 [SEC. 11102.(a)] SEC. 1860D–14B.(b)(2)(B)(ii) the total number of units of such dosage form and strength reported under section 1927 with respect to such period, as determined by the Secretary.
816 149.5 - 149.10 [SEC. 11102.(a)] SEC. 1860D–14B.(b)(3) DETERMINATION OF INFLATION-ADJUSTED PAYMENT AMOUNT. The inflation-adjusted payment amount determined under this paragraph for a dosage form and strength with respect to a part D rebatable drug for an applicable period, subject to paragraph (5), is
817 149.11 - 149.14 [SEC. 11102.(a)] SEC. 1860D–14B.(b)(3)(A) the benchmark period manufacturer price determined under paragraph (4) for such dosage form and strength with respect to such drug and period; increased by
818 149.15 - 149.18 [SEC. 11102.(a)] SEC. 1860D–14B.(b)(3)(B) the percentage by which the applicable period CPI–U (as defined in subsection (g)(5)) for the period exceeds the benchmark period CPI–U (as defined in subsection (g)(4)).
819 149.19 - 149.24 [SEC. 11102.(a)] SEC. 1860D–14B.(b)(4) DETERMINATION OF BENCHMARK PERIOD MANUFACTURER PRICE. The benchmark period manufacturer price determined under this paragraph for a dosage form and strength, with respect to a part D rebatable drug and an applicable period, is the sum of the products of
820 150.1 - 150.6 [SEC. 11102.(a)] SEC. 1860D–14B.(b)(4)(A) the average manufacturer price (as defined in subsection (g)(6)) of such dosage form and strength, as calculated for a unit of such drug, with respect to each of the calendar quarters of the payment amount benchmark period (as defined in subsection (g)(3)); and
821 150.7 - 150.7 [SEC. 11102.(a)] SEC. 1860D–14B.(b)(4)(B) the ratio of
822 150.8 - 150.12 [SEC. 11102.(a)] SEC. 1860D–14B.(b)(4)(B)(i) the total number of units reported under section 1927 of such dosage form and strength with respect to each such calendar quarter of such payment amount benchmark period; to
823 150.13 - 150.16 [SEC. 11102.(a)] SEC. 1860D–14B.(b)(4)(B)(ii) the total number of units reported under section 1927 of such dosage form and strength with respect to such payment amount benchmark period.
824 150.17 - 150.18 [SEC. 11102.(a)] SEC. 1860D–14B.(b)(5) SPECIAL TREATMENT OF CERTAIN DRUGS AND EXEMPTION.
825 150.19 - 151.9 [SEC. 11102.(a)] SEC. 1860D–14B.(b)(5)(A) SUBSEQUENTLY APPROVED DRUGS. In the case of a part D rebatable drug first approved or licensed by the Food and Drug Administration after October 1, 2021, subparagraphs (A) and (B) of paragraph (4) shall be applied as if the term ‘payment amount benchmark period’ were defined under subsection (g)(3) as the first calendar year beginning after the day on which the drug was first marketed and subparagraph (B) of paragraph (3) shall be applied as if the term ‘benchmark period CPI–U’ were defined under subsection (g)(4) as if the reference to ‘January 2021’ under such subsection were a reference to ‘January of the first year beginning after the date on which the drug was first marketed’.
828 151.10 - 151.11 [SEC. 11102.(a)] SEC. 1860D–14B.(b)(5)(B) TREATMENT OF NEW FORMULATIONS.
829 151.12 - 151.24 [SEC. 11102.(a)] SEC. 1860D–14B.(b)(5)(B)(i) IN GENERAL. In the case of a part D rebatable drug that is a line extension of a part D rebatable drug that is an oral solid dosage form, the Secretary shall establish a formula for determining the rebate amount under paragraph (1) and the inflation adjusted payment amount under paragraph (3) with respect to such part D rebatable drug and an applicable period, consistent with the formula applied under subsection (c)(2)(C) of section 1927 for determining a rebate obligation for a rebate period under such section.
830 152.1 - 152.10 [SEC. 11102.(a)] SEC. 1860D–14B.(b)(5)(B)(ii) LINE EXTENSION DEFINED. In this subparagraph, 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.
831 152.11 - 153.7 [SEC. 11102.(a)] SEC. 1860D–14B.(b)(5)(C) SELECTED DRUGS. In the case of a part D rebatable drug that is a selected drug (as defined in section 1192(c)) with respect to a price applicability period (as defined in section 1191(b)(2)), in the case such drug is no longer considered to be a selected drug under section 1192(c), for each applicable period (as defined under subsection (g)(7)) beginning after the price applicability period with respect to such drug, subparagraphs (A) and (B) of paragraph (4) shall be applied as if the term ‘payment amount benchmark period’ were defined under subsection (g)(3) as the last year beginning during such price applicability period with respect to such selected drug and subparagraph (B) of paragraph (3) shall be applied as if the term ‘benchmark period CPI–U’ were defined under subsection (g)(4) as if the reference to ‘January 2021’ under such subsection were a reference to ‘January of the last year beginning during such price applicability period with respect to such drug’.
833 153.8 - 153.24 [SEC. 11102.(a)] SEC. 1860D–14B.(b)(6) RECONCILIATION IN CASE OF REVISED INFORMATION. The Secretary shall provide for a method and process under which, in the case where a PDP sponsor of a prescription drug plan or an MA organization offering an MA–PD plan submits revisions to the number of units of a rebatable covered part D drug dispensed, the Secretary determines, pursuant to such revisions, adjustments, if any, to the calculation of the amount specified in this subsection for a dosage form and strength with respect to such part D rebatable drug and an applicable period and reconciles any overpayments or underpayments in amounts paid as rebates under this subsection. Any identified underpayment shall be rectified by the manufacturer not later than 30 days after the date of receipt from the Secretary of information on such underpayment.
834 154.1 - 154.5 [SEC. 11102.(a)] SEC. 1860D–14B.(c) REBATE DEPOSITS. Amounts paid as rebates under subsection (b) shall be deposited into the Medicare Prescription Drug Account in the Federal Supplementary Medical Insurance Trust Fund established under section 1841.
835 154.6 - 154.7 [SEC. 11102.(a)] SEC. 1860D–14B.(d) INFORMATION. For purposes of carrying out this section, the Secretary shall use information submitted by
836 154.8 - 154.8 [SEC. 11102.(a)] SEC. 1860D–14B.(d)(1) manufacturers under section 1927(b)(3);
837 154.9 - 154.9 [SEC. 11102.(a)] SEC. 1860D–14B.(d)(2) States under section 1927(b)(2)(A); and
838 154.10 - 154.12 [SEC. 11102.(a)] SEC. 1860D–14B.(d)(3) PDP sponsors of prescription drug plans and MA organization offering MA–PD plans under this part.
839 154.13 - 154.24 [SEC. 11102.(a)] SEC. 1860D–14B.(e) CIVIL MONEY PENALTY. If a manufacturer of a part D rebatable drug has failed to comply with the requirement under subsection (a)(2) with respect to such drug for an applicable period, the manufacturer shall be subject to a civil money penalty in an amount equal to 125 percent of the amount specified in subsection (b) for such drug for such period. The provisions of section 1128A (other than subsections (a) (with respect to amounts of penalties or additional assessments) and (b)) shall apply to a civil money penalty under this subsection in the same manner as such provisions apply to a penalty or proceeding under section 1128A(a).
840 155.1 - 155.3 [SEC. 11102.(a)] SEC. 1860D–14B.(f) LIMITATION ON ADMINISTRATIVE OR JUDICIAL REVIEW. There shall be no administrative or judicial review of any of the following:
841 155.4 - 155.5 [SEC. 11102.(a)] SEC. 1860D–14B.(f)(1) The determination of units under this section.
842 155.6 - 155.7 [SEC. 11102.(a)] SEC. 1860D–14B.(f)(2) The determination of whether a drug is a part D rebatable drug under this section.
843 155.8 - 155.9 [SEC. 11102.(a)] SEC. 1860D–14B.(f)(3) The calculation of the rebate amount under this section.
844 155.10 - 155.10 [SEC. 11102.(a)] SEC. 1860D–14B.(g) DEFINITIONS. In this section:
845 155.11 - 155.11 [SEC. 11102.(a)] SEC. 1860D–14B.(g)(1) PART D REBATABLE DRUG.
846 155.12 - 155.17 [SEC. 11102.(a)] SEC. 1860D–14B.(g)(1)(A) IN GENERAL. Except as provided in subparagraph (B), 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 1860D–2(e)).
847 155.18 - 155.18 [SEC. 11102.(a)] SEC. 1860D–14B.(g)(1)(B) EXCLUSION.
848 155.19 - 156.3 [SEC. 11102.(a)] SEC. 1860D–14B.(g)(1)(B)(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.
849 156.4 - 156.5 [SEC. 11102.(a)] SEC. 1860D–14B.(g)(1)(B)(ii) INCREASE. The dollar amount applied under clause (i)
850 156.6 - 156.15 [SEC. 11102.(a)] SEC. 1860D–14B.(g)(1)(B)(ii)(I) for the applicable period beginning October 1, 2023, shall be the dollar amount specified under such clause for the applicable period beginning October 1, 2022, increased by the percentage increase in the consumer price index for all urban consumers (United States city average) for the 12month period beginning with October of 2023; and
851 156.16 - 157.3 [SEC. 11102.(a)] SEC. 1860D–14B.(g)(1)(B)(ii)(II) for a subsequent applicable period, shall be the dollar amount specified in this clause for the previous applicable period, increased by the percentage increase in the consumer price index for all urban consumers (United States city average) for the 12-month period beginning with October of the previous period. Any dollar amount specified under this clause that is not a multiple of $10 shall be rounded to the nearest multiple of $10.
852 157.4 - 157.7 [SEC. 11102.(a)] SEC. 1860D–14B.(g)(1)(C) DRUG OR BIOLOGICAL DESCRIBED. A drug or biological described in this subparagraph is a drug or biological that, as of the first day of the applicable period involved, is
853 157.8 - 157.10 [SEC. 11102.(a)] SEC. 1860D–14B.(g)(1)(C)(i) a drug approved under a new drug application under section 505(c) of the Federal Food, Drug, and Cosmetic Act;
854 157.11 - 157.14 [SEC. 11102.(a)] SEC. 1860D–14B.(g)(1)(C)(ii) a drug approved under an abbreviated new drug application under section 505(j) of the Federal Food, Drug, and Cosmetic Act, in the case where
855 157.15 - 157.24 [SEC. 11102.(a)] SEC. 1860D–14B.(g)(1)(C)(ii)(I) the reference listed drug approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act, including any ‘authorized generic drug’ (as that term is defined in section 505(t)(3) of the Federal Food, Drug, and Cosmetic Act), is not being marketed, as identified in the Food and Drug Administration’s National Drug Code Directory;
856 158.1 - 158.11 [SEC. 11102.(a)] SEC. 1860D–14B.(g)(1)(C)(ii)(II) there is no other drug approved under section 505(j) of the Federal Food, Drug, and Cosmetic Act that is rated as therapeutically equivalent (under the Food and Drug Administration’s most recent publication of ‘Approved Drug Products with Therapeutic Equivalence Evaluations’) and that is being marketed, as identified in the Food and Drug Administration’s National Drug Code Directory;
857 158.12 - 158.17 [SEC. 11102.(a)] SEC. 1860D–14B.(g)(1)(C)(ii)(III) the manufacturer is not a ‘first applicant’ during the ‘180-day exclusivity period’, as those terms are defined in section 505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic Act; and
858 158.18 - 158.23 [SEC. 11102.(a)] SEC. 1860D–14B.(g)(1)(C)(ii)(IV) the manufacturer is not a ‘first approved applicant’ for a competitive generic therapy, as that term is defined in section 505(j)(5)(B)(v) of the Federal Food, Drug, and Cosmetic Act; or
859 158.24 - 158.25 [SEC. 11102.(a)] SEC. 1860D–14B.(g)(1)(C)(iii) a biological licensed under section 351 of the Public Health Service Act.
860 159.1 - 159.5 [SEC. 11102.(a)] SEC. 1860D–14B.(g)(2) UNIT. 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 1927.
861 159.6 - 159.9 [SEC. 11102.(a)] SEC. 1860D–14B.(g)(3) PAYMENT AMOUNT BENCHMARK PERIOD. The term ‘payment amount benchmark period’ means the period beginning January 1, 2021, and ending in the month immediately prior to October 1, 2021.
862 159.10 - 159.13 [SEC. 11102.(a)] SEC. 1860D–14B.(g)(4) BENCHMARK PERIOD CPI–U. The term ‘benchmark period CPI–U’ means the consumer price index for all urban consumers (United States city average) for January 2021.
863 159.14 - 159.18 [SEC. 11102.(a)] SEC. 1860D–14B.(g)(5) APPLICABLE PERIOD CPI–U. 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.
864 159.19 - 159.24 [SEC. 11102.(a)] SEC. 1860D–14B.(g)(6) AVERAGE MANUFACTURER PRICE. The term ‘average manufacturer price’ has the meaning, with respect to a part D rebatable drug of a manufacturer, given such term in section 1927(k)(1), with respect to a covered outpatient drug of a manufacturer for a rebate period under section 1927.
865 160.1 - 160.3 [SEC. 11102.(a)] SEC. 1860D–14B.(g)(7) APPLICABLE PERIOD. The term ‘applicable period’ means a 12-month period beginning with October 1 of a year (beginning with October 1, 2022).
866 160.4 - 160.7 [SEC. 11102.(a)] SEC. 1860D–14B.(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.’’.
867 160.8 - 160.8 SEC. 11102.(b) CONFORMING AMENDMENTS.
868 160.9 - 160.14 SEC. 11102.(b)(1) TO PART B ASP CALCULATION. Section 1847A(c)(3) of the Social Security Act (42 U.S.C. 1395w–3a(c)(3)), as amended by section 11101(c)(1), is amended by striking ‘‘subsection (i) or section 1927’’ and inserting ‘‘subsection (i), section 1927, or section 1860D–14B’’.
869 160.15 - 160.21 SEC. 11102.(b)(2) EXCLUDING PART D DRUG INFLATION REBATE FROM BEST PRICE. Section 1927(c)(1)(C)(ii)(I) of the Social Security Act (42 U.S.C. 1396r–8(c)(1)(C)(ii)(I)), as amended by section 11101(c)(2), is amended by striking ‘‘or section 1847A(i)’’ and inserting ‘‘, section 1847A(i), or section 1860D–14B’’.
870 160.22 - 161.5 SEC. 11102.(b)(3) COORDINATION WITH MEDICAID REBATE INFORMATION DISCLOSURE. Section 1927(b)(3)(D)(i) of the Social Security Act (42 U.S.C. 1396r– 8(b)(3)(D)(i)), as amended by sections 11002(b) and 11101(c)(3), is amended by striking ‘‘or section 1192(f), including rebates under paragraph (4) of such section’’ and inserting ‘‘, section 1192(f), including rebates under paragraph (4) of such section, or section 1860D–14B’’.
871 161.6 - 161.11 SEC. 11102.(b)(4) EXCLUDING PART D DRUG INFLATION REBATES FROM AVERAGE MANUFACTURER PRICE. Section 1927(k)(1)(B)(i) of the Social Security Act (42 U.S.C. 1396r–8(k)(1)(B)(i)), as amended by section 11001(b)(3) and section 11101(c)(4), is amended by adding at the end the following new subclause:
872 161.12 - 161.13 SEC. 11102.(b)(4)(A) in subclause (VI), by striking ‘‘and’’ at the end;
873 161.14 - 161.15 SEC. 11102.(b)(4)(B) in subclause (VII), by striking the period at the end and inserting a semicolon; and
874 161.16 - 161.17 SEC. 11102.(b)(4)(C) by adding at the end the following new subclause:
875 161.18 - 161.19 [SEC. 11102.(b)(4)(C)] (VIII) rebates paid by manufacturers under section 1860D–14B.’’.
876 161.20 - 162.4 SEC. 11102.(c) FUNDING. In addition to amounts otherwise available, there are appropriated to the Centers for Medicare & Medicaid Services, out of any money in the Treasury not otherwise appropriated, $80,000,000 for fiscal year 2022, including $12,500,000 to carry out the provisions of, including the amendments made by, this section in fiscal year 2022, and $7,500,000 to carry out the provisions of, including the amendments made by, this section in each of fiscal years 2023 through 2031, to remain available until expended.
877 162.5 - 162.7 TITLE I Subtitle B PART 3 PART D IMPROVEMENTS AND MAXIMUM OUT-OF-POCKET CAP FOR MEDICARE BENEFICIARIES
878 162.8 - 162.8 TITLE I Subtitle B PART 3 SEC. 11201. MEDICARE PART D BENEFIT REDESIGN.
879 162.9 - 162.11 SEC. 11201.(a) BENEFIT STRUCTURE REDESIGN. Section 1860D–2(b) of the Social Security Act (42 U.S.C. 1395w– 102(b)) is amended
880 162.12 - 162.12 SEC. 11201.(a)(1) in paragraph (2)
881 162.13 - 162.19 SEC. 11201.(a)(1)(A) in subparagraph (A), in the matter preceding clause (i), by inserting ‘‘for a year preceding 2025 and for costs above the annual deductible specified in paragraph (1) and up to the annual out-of-pocket threshold specified in paragraph (4)(B) for 2025 and each subsequent year’’ after ‘‘paragraph (3)’’;
882 162.20 - 162.20 SEC. 11201.(a)(1)(B) in subparagraph (C)
883 162.21 - 162.24 SEC. 11201.(a)(1)(B)(i) in clause (i), in the matter preceding subclause (I), by inserting ‘‘for a year preceding 2025,’’ after ‘‘paragraph (4),’’; and
885 163.1 - 163.3 SEC. 11201.(a)(1)(B)(ii) in clause (ii)(III), by striking ‘‘and each subsequent year’’ and inserting ‘‘through 2024’’; and
886 163.4 - 163.4 SEC. 11201.(a)(1)(C) in subparagraph (D)
887 163.5 - 163.5 SEC. 11201.(a)(1)(C)(i) in clause (i)
888 163.6 - 163.9 SEC. 11201.(a)(1)(C)(i)(I) in the matter preceding subclause (I), by inserting ‘‘for a year preceding 2025,’’ after ‘‘paragraph (4),’’; and
889 163.10 - 163.13 SEC. 11201.(a)(1)(C)(i)(II) in subclause (I)(bb), by striking ‘‘a year after 2018’’ and inserting ‘‘each of years 2019 through 2024’’; and
890 163.14 - 163.16 SEC. 11201.(a)(1)(C)(ii) in clause (ii)(V), by striking ‘‘2019 and each subsequent year’’ and inserting ‘‘each of years 2019 through 2024’’;
891 163.17 - 163.17 SEC. 11201.(a)(2) in paragraph (3)(A)
892 163.18 - 163.20 SEC. 11201.(a)(2)(A) in the matter preceding clause (i), by inserting ‘‘for a year preceding 2025,’’ after ‘‘and (4),’’; and
893 163.21 - 163.23 SEC. 11201.(a)(2)(B) in clause (ii), by striking ‘‘for a subsequent year’’ and inserting ‘‘for each of years 2007 through 2024’’; and
894 163.24 - 163.24 SEC. 11201.(a)(3) in paragraph (4)
895 163.25 - 163.25 SEC. 11201.(a)(3)(A) in subparagraph (A)
896 164.1 - 164.1 SEC. 11201.(a)(3)(A)(i) in clause (i)
897 164.2 - 164.6 SEC. 11201.(a)(3)(A)(i)(I) by redesignating subclauses (I) and (II) as items (aa) and (bb), respectively, and moving the margin of each such redesignated item 2 ems to the right;
898 164.7 - 164.12 SEC. 11201.(a)(3)(A)(i)(II) in the matter preceding item (aa), as redesignated by subclause (I), by striking ‘‘is equal to the greater of ’’ and inserting ‘‘is equal to (I) for a year preceding 2024, the greater of ’’;
901 164.13 - 164.16 SEC. 11201.(a)(3)(A)(i)(III) by striking the period at the end of item (bb), as redesignated by subclause (I), and inserting ‘‘; and’’; and
902 164.17 - 164.18 SEC. 11201.(a)(3)(A)(i)(IV) by adding at the end the following:
903 164.19 - 164.20 [SEC. 11201.(a)(3)(A)(i)(IV)] (II) for 2024 and each succeeding year, $0.’’; and
904 164.21 - 164.21 SEC. 11201.(a)(3)(A)(ii) in clause (ii)
905 164.22 - 164.23 SEC. 11201.(a)(3)(A)(ii)(I) by striking ‘‘clause (i)(I)’’ and inserting ‘‘clause (i)(I)(aa)’’; and
906 164.24 - 165.5 SEC. 11201.(a)(3)(A)(ii)(II) by adding at the end the following new sentence: ‘‘The Secretary shall continue to calculate the dollar amounts specified in clause (i)(I)(aa), including with the adjustment under this clause, after 2023 for purposes of section 1860D–14(a)(1)(D)(iii).’’;
907 165.6 - 165.6 SEC. 11201.(a)(3)(B) in subparagraph (B)
908 165.7 - 165.7 SEC. 11201.(a)(3)(B)(i) in clause (i)
909 165.8 - 165.9 SEC. 11201.(a)(3)(B)(i)(I) in subclause (V), by striking ‘‘or’’ at the end;
910 165.10 - 165.10 SEC. 11201.(a)(3)(B)(i)(II) in subclause (VI)
911 165.11 - 165.14 SEC. 11201.(a)(3)(B)(i)(II)(aa) by striking ‘‘for a subsequent year’’ and inserting ‘‘for each of years 2021 through 2024’’; and
912 165.15 - 165.17 SEC. 11201.(a)(3)(B)(i)(II)(bb) by striking the period at the end and inserting a semicolon; and
913 165.18 - 165.19 SEC. 11201.(a)(3)(B)(i)(III) by adding at the end the following new subclauses:
914 165.20 - 165.21 [SEC. 11201.(a)(3)(B)(i)(III)] (VII) for 2025, is equal to $2,000; or
915 165.22 - 166.2 [SEC. 11201.(a)(3)(B)(i)(III)] (VIII) for a subsequent year, 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.’’; and
916 166.3 - 166.4 SEC. 11201.(a)(3)(B)(ii) in clause (ii), by striking ‘‘clause (i)(II)’’ and inserting ‘‘clause (i)’’;
918 166.5 - 166.5 SEC. 11201.(a)(3)(C) in subparagraph (C)
919 166.6 - 166.8 SEC. 11201.(a)(3)(C)(i) in clause (i), by striking ‘‘and for amounts’’ and inserting ‘‘and, for a year preceding 2025, for amounts’’; and
920 166.9 - 166.9 SEC. 11201.(a)(3)(C)(ii) in clause (iii)
921 166.10 - 166.12 SEC. 11201.(a)(3)(C)(ii)(I) by redesignating subclauses (I) through (IV) as items (aa) through (dd) and indenting appropriately;
923 166.13 - 166.16 SEC. 11201.(a)(3)(C)(ii)(II) by striking ‘‘if such costs are borne or paid’’ and inserting ‘‘if such costs (I) are borne or paid ’’; and
925 166.17 - 166.19 SEC. 11201.(a)(3)(C)(ii)(III) in item (dd), by striking the period at the end and inserting ‘‘; or’’; and
926 166.20 - 166.21 SEC. 11201.(a)(3)(C)(ii)(IV) by adding at the end the following new subclause:
927 166.22 - 167.8 [SEC. 11201.(a)(3)(C)(ii)(IV)] (II) for 2025 and subsequent years, are reimbursed through insurance, a group health plan, or certain other third party payment arrangements, but not including the coverage provided by a prescription drug plan or an MA–PD plan that is basic prescription drug coverage (as defined in subsection (a)(3)) or any payments by a manufacturer under the manufacturer discount program under section 1860D–14C.’’; and
928 167.9 - 167.11 SEC. 11201.(a)(3)(D) in subparagraph (E), by striking ‘‘In applying’’ and inserting ‘‘For each of years 2011 through 2024, in applying’’.
929 167.12 - 167.14 SEC. 11201.(b) REINSURANCE PAYMENT AMOUNT. Section 1860D–15(b) of the Social Security Act (42 U.S.C. 1395w– 115(b)) is amended
930 167.15 - 167.15 SEC. 11201.(b)(1) in paragraph (1)
931 167.16 - 167.17 SEC. 11201.(b)(1)(A) by striking ‘‘equal to 80 percent’’ and inserting ‘‘equal to
932 167.18 - 167.19 [SEC. 11201.(b)(1)(A)] (A) for a year preceding 2025, 80 percent’’;
933 167.20 - 167.22 SEC. 11201.(b)(1)(B) in subparagraph (A), as added by subparagraph (A), by striking the period at the end and inserting ‘‘; and’’; and
934 167.23 - 167.24 SEC. 11201.(b)(1)(C) by adding at the end the following new subparagraph:
935 168.1 - 168.2 [SEC. 11201.(b)(1)(C)] (B) for 2025 and each subsequent year, the sum of
936 168.3 - 168.12 [SEC. 11201.(b)(1)(C)] (B)(i) with respect to applicable drugs (as defined in section 1860D–14C(g)(2)), an amount equal to 20 percent of such allowable reinsurance costs attributable to that portion of gross covered prescription drug costs as specified in paragraph (3) incurred in the coverage year after such individual has incurred costs that exceed the annual out-of-pocket threshold specified in section 1860D–2(b)(4)(B); and
937 168.13 - 168.22 [SEC. 11201.(b)(1)(C)] (B)(ii) with respect to covered part D drugs that are not applicable drugs (as so defined), an amount equal to 40 percent of such allowable reinsurance costs attributable to that portion of gross covered prescription drug costs as specified in paragraph (3) incurred in the coverage year after such individual has incurred costs that exceed the annual out-of-pocket threshold specified in section 1860D–2(b)(4)(B).’’;
938 168.23 - 168.23 SEC. 11201.(b)(2) in paragraph (2)
939 168.24 - 168.25 SEC. 11201.(b)(2)(A) by striking ‘‘COSTS. For purposes’’ and inserting ‘‘COSTS.
940 169.1 - 169.2 [SEC. 11201.(b)(2)(A)] (A) IN GENERAL. Subject to subparagraph (B), for purposes’’; and
941 169.3 - 169.4 SEC. 11201.(b)(2)(B) by adding at the end the following new subparagraph:
942 169.5 - 169.13 [SEC. 11201.(b)(2)(B)] (B) INCLUSION OF MANUFACTURER DISCOUNTS ON APPLICABLE DRUGS. For purposes of applying subparagraph (A), the term ‘allowable reinsurance costs’ shall include the portion of the negotiated price (as defined in section 1860D–14C(g)(6)) of an applicable drug (as defined in section 1860D–14C(g)(2)) that was paid by a manufacturer under the manufacturer discount program under section 1860D–14C.’’; and
943 169.14 - 169.14 SEC. 11201.(b)(3) in paragraph (3)
944 169.15 - 169.17 SEC. 11201.(b)(3)(A) in the first sentence, by striking ‘‘For purposes’’ and inserting ‘‘Subject to paragraph (2)(B), for purposes’’; and
946 169.18 - 169.22 SEC. 11201.(b)(3)(B) in the second sentence, by inserting ‘‘(or, with respect to 2025 and subsequent years, in the case of an applicable drug, as defined in section 1860D–14C(g)(2), by a manufacturer)’’ after ‘‘by the individual or under the plan’’.
947 169.23 - 169.23 SEC. 11201.(c) MANUFACTURER DISCOUNT PROGRAM.
948 169.24 - 170.3 SEC. 11201.(c)(1) IN GENERAL. Part D of title XVIII of the Social Security Act (42 U.S.C. 1395w–101 through 42 U.S.C. 1395w–153), as amended by section 11102, is amended by inserting after section 1860D–14B the following new sections:
949 170.4 - 170.4 [SEC. 11201.(c)(1)] SEC. 1860D–14C. MANUFACTURER DISCOUNT PROGRAM.
950 170.5 - 170.10 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(a) ESTABLISHMENT. The Secretary shall establish a manufacturer discount program (in this section referred to as the ‘program’). Under the program, the Secretary shall enter into agreements described in subsection (b) with manufacturers and provide for the performance of the duties described in subsection (c).
951 170.11 - 170.11 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(b) TERMS OF AGREEMENT.
952 170.12 - 170.12 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(b)(1) IN GENERAL.
953 170.13 - 170.18 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(b)(1)(A) AGREEMENT. An agreement under this section shall require the manufacturer to provide, in accordance with this section, discounted prices for applicable drugs of the manufacturer that are dispensed to applicable beneficiaries on or after January 1, 2025.
954 170.19 - 170.20 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(b)(1)(B) CLARIFICATION. Nothing in this section shall be construed as affecting
955 170.21 - 170.25 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(b)(1)(B)(i) the application of a coinsurance of 25 percent of the negotiated price, as applied under paragraph (2)(A) of section 1860D–2(b), for costs described in such paragraph; or
956 171.1 - 171.4 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(b)(1)(B)(ii) the application of the copayment amount described in paragraph (4)(A) of such section, with respect to costs described in such paragraph.
957 171.5 - 171.5 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(b)(1)(C) TIMING OF AGREEMENT.
958 171.6 - 171.12 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(b)(1)(C)(i) SPECIAL RULE FOR 2025. In order for an agreement with a manufacturer to be in effect under this section with respect to the period beginning on January 1, 2025, and ending on December 31, 2025, the manufacturer shall enter into such agreement not later than March 1, 2024.
959 171.13 - 171.20 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(b)(1)(C)(ii) 2026 AND SUBSEQUENT YEARS. In order for an agreement with a manufacturer to be in effect under this section with respect to plan year 2026 or a subsequent plan year, the manufacturer shall enter into such agreement not later than a calendar quarter or semi-annual deadline established by the Secretary.
960 171.21 - 172.2 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(b)(2) PROVISION OF APPROPRIATE DATA. Each manufacturer with an agreement in effect under this section shall collect and have available appropriate data, as determined by the Secretary, to ensure that it can demonstrate to the Secretary compliance with the requirements under the program.
961 172.3 - 172.10 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(b)(3) COMPLIANCE WITH REQUIREMENTS FOR ADMINISTRATION OF PROGRAM. Each manufacturer with an agreement in effect under this section shall comply with requirements imposed by the Secretary, as applicable, for purposes of administering the program, including any determination under subparagraph (A) of subsection (c)(1) or procedures established under such subsection (c)(1).
962 172.11 - 172.11 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(b)(4) LENGTH OF AGREEMENT.
963 172.12 - 172.17 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(b)(4)(A) IN GENERAL. An agreement under this section shall be effective for an initial period of not less than 12 months and shall be automatically renewed for a period of not less than 1 year unless terminated under subparagraph (B).
965 172.18 - 172.18 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(b)(4)(B) TERMINATION.
966 172.19 - 173.8 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(b)(4)(B)(i) BY THE SECRETARY. The Secretary shall provide for termination of an agreement under this section for a knowing and willful violation of the requirements of the agreement or other good cause shown. Such termination shall not be effective earlier than 30 days after the date of notice to the manufacturer of such termination. The Secretary shall provide, upon request, a manufacturer with a hearing concerning such a termination, and such hearing shall take place prior to the effective date of the termination with sufficient time for such effective date to be repealed if the Secretary determines appropriate.
967 173.9 - 173.13 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(b)(4)(B)(ii) BY A MANUFACTURER. A manufacturer may terminate an agreement under this section for any reason. Any such termination shall be effective, with respect to a plan year
968 173.14 - 173.17 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(b)(4)(B)(ii)(I) if the termination occurs before January 31 of a plan year, as of the day after the end of the plan year; and
969 173.18 - 173.21 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(b)(4)(B)(ii)(II) if the termination occurs on or after January 31 of a plan year, as of the day after the end of the succeeding plan year.
970 173.22 - 174.2 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(b)(4)(B)(iii) EFFECTIVENESS OF TERMINATION. Any termination under this subparagraph shall not affect discounts for applicable drugs of the manufacturer that are due under the agreement before the effective date of its termination.
971 174.3 - 174.6 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(b)(5) EFFECTIVE DATE OF AGREEMENT. An agreement under this section shall take effect at the start of a calendar quarter or another date specified by the Secretary.
972 174.7 - 174.8 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(c) DUTIES DESCRIBED. The duties described in this subsection are the following:
973 174.9 - 174.10 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(c)(1) ADMINISTRATION OF PROGRAM. Administering the program, including
974 174.11 - 174.13 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(c)(1)(A) the determination of the amount of the discounted price of an applicable drug of a manufacturer;
975 174.14 - 174.20 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(c)(1)(B) the establishment of procedures to ensure that, not later than the applicable number of calendar days after the dispensing of an applicable drug by a pharmacy or mail order service, the pharmacy or mail order service is reimbursed for an amount equal to the difference between
976 174.21 - 174.22 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(c)(1)(B)(i) the negotiated price of the applicable drug; and
977 174.23 - 174.24 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(c)(1)(B)(ii) the discounted price of the applicable drug;
978 175.1 - 175.9 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(c)(1)(C) the establishment of procedures to ensure that the discounted price for an applicable drug under this section is applied before any coverage or financial assistance under other health benefit plans or programs that provide coverage or financial assistance for the purchase or provision of prescription drug coverage on behalf of applicable beneficiaries as specified by the Secretary; and
979 175.10 - 175.13 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(c)(1)(D) providing a reasonable dispute resolution mechanism to resolve disagreements between manufacturers, prescription drug plans and MA–PD plans, and the Secretary.
980 175.14 - 175.16 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(c)(2) MONITORING COMPLIANCE. The Secretary shall monitor compliance by a manufacturer with the terms of an agreement under this section.
981 175.17 - 175.22 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(c)(3) COLLECTION OF DATA FROM PRESCRIPTION DRUG PLANS AND MA–PD PLANS. The Secretary may collect appropriate data from prescription drug plans and MA–PD plans in a timeframe that allows for discounted prices to be provided for applicable drugs under this section.
982 175.23 - 175.23 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(d) ADMINISTRATION.
983 175.24 - 176.2 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(d)(1) IN GENERAL. Subject to paragraph (2), the Secretary shall provide for the implementation of this section, including the performance of the duties described in subsection (c).
984 176.3 - 176.6 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(d)(2) LIMITATION. In providing for the implementation of this section, the Secretary shall not receive or distribute any funds of a manufacturer under the program.
985 176.7 - 176.7 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(e) CIVIL MONEY PENALTY.
986 176.8 - 176.14 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(e)(1) IN GENERAL. A manufacturer that fails to provide discounted prices for applicable drugs of the manufacturer dispensed to applicable beneficiaries in accordance with an agreement in effect under this section shall be subject to a civil money penalty for each such failure in an amount the Secretary determines is equal to the sum of
987 176.15 - 176.19 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(e)(1)(A) the amount that the manufacturer would have paid with respect to such discounts under the agreement, which will then be used to pay the discounts which the manufacturer had failed to provide; and
988 176.20 - 176.20 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(e)(1)(B) 25 percent of such amount.
989 176.21 - 176.25 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(e)(2) APPLICATION. The provisions of section 1128A (other than subsections (a) and (b)) shall apply to a civil money penalty under this subsection in the same manner as such provisions apply to a penalty or proceeding under section 1128A(a).
990 177.1 - 177.7 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(f) CLARIFICATION REGARDING AVAILABILITY OF OTHER COVERED PART D DRUGS. Nothing in this section shall prevent an applicable beneficiary from purchasing a covered part D drug that is not an applicable drug (including a generic drug or a drug that is not on the formulary of the prescription drug plan or MA–PD plan that the applicable beneficiary is enrolled in).
991 177.8 - 177.8 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g) DEFINITIONS. In this section:
992 177.9 - 177.11 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(1) APPLICABLE BENEFICIARY. The term ‘applicable beneficiary’ means an individual who, on the date of dispensing a covered part D drug
993 177.12 - 177.13 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(1)(A) is enrolled in a prescription drug plan or an MA–PD plan;
994 177.14 - 177.15 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(1)(B) is not enrolled in a qualified retiree prescription drug plan; and
995 177.16 - 177.20 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(1)(C) has incurred costs, as determined in accordance with section 1860D–2(b)(4)(C), for covered part D drugs in the year that exceed the annual deductible specified in section 1860D– 2(b)(1).
996 177.21 - 177.22 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(2) APPLICABLE DRUG. The term ‘applicable drug’, with respect to an applicable beneficiary
997 177.23 - 177.23 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(2)(A) means a covered part D drug
998 177.24 - 178.4 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(2)(A)(i) approved under a new drug application under section 505(c) of the Federal Food, Drug, and Cosmetic Act or, in the case of a biologic product, licensed under section 351 of the Public Health Service Act; and
999 178.5 - 178.10 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(2)(A)(ii)(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;
1000 178.11 - 178.17 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(2)(A)(ii)(II) if the PDP sponsor of the prescription drug plan or the MA organization offering the MA–PD plan does not use a formulary, for which benefits are available under the prescription drug plan or MA– PD plan that the applicable beneficiary is enrolled in; or
1001 178.18 - 178.19 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(2)(A)(ii)(III) is provided through an exception or appeal; and
1002 178.20 - 178.23 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(2)(B) does not include a selected drug (as referred to under section 1192(c)) during a price applicability period (as defined in section 1191(b)(2)) with respect to such drug.
1003 179.1 - 179.3 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(3) APPLICABLE NUMBER OF CALENDAR DAYS. The term ‘applicable number of calendar days’ means
1004 179.4 - 179.5 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(3)(A) with respect to claims for reimbursement submitted electronically, 14 days; and
1005 179.6 - 179.7 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(3)(B) with respect to claims for reimbursement submitted otherwise, 30 days.
1006 179.8 - 179.8 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4) DISCOUNTED PRICE.
1007 179.9 - 179.13 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(A) IN GENERAL. 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
1009 179.14 - 179.21 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(A)(i) who has not incurred costs, as determined in accordance with section 1860D–2(b)(4)(C), for covered part D drugs in the year that are equal to or exceed the annual out-of-pocket threshold specified in section 1860D–2(b)(4)(B)(i) for the year, 90 percent of the negotiated price of such drug; and
1010 179.22 - 179.25 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(A)(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.
1011 180.1 - 180.2 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(B) PHASE-IN FOR CERTAIN DRUGS DISPENSED TO LIS BENEFICIARIES.
1012 180.3 - 180.13 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(B)(i) IN GENERAL. In the case of an applicable drug of a specified manufacturer (as defined in clause (ii)) that is marketed as of the date of enactment of this subparagraph and dispensed for an applicable beneficiary who is a subsidy eligible individual (as defined in section 1860D–14(a)(3)), the term ‘discounted price’ means the specified LIS percent (as defined in clause (iii)) of the negotiated price of the applicable drug of the manufacturer.
1013 180.14 - 180.14 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(B)(ii) SPECIFIED MANUFACTURER.
1014 180.15 - 180.19 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(B)(ii)(I) IN GENERAL. In this subparagraph, subject to subclause (II), the term ‘specified manufacturer’ means a manufacturer of an applicable drug for which, in 2021
1015 180.20 - 180.22 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(B)(ii)(I)(aa) the manufacturer had a coverage gap discount agreement under section 1860D–14A;
1016 180.23 - 181.7 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(B)(ii)(I)(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 D drugs during such year; and
1017 181.8 - 181.19 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(B)(ii)(I)(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 represented less than 1.0 percent of the total expenditures under part B for all drugs or biological products for which payment may be made under such part during such year.
1018 181.20 - 181.20 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(B)(ii)(II) SPECIFIED DRUGS.
1019 181.21 - 182.3 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(B)(ii)(II)(aa) IN GENERAL. For purposes of this clause, 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.
1020 182.4 - 182.17 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(B)(ii)(II)(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.
1021 182.18 - 183.3 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(B)(ii)(III) LIMITATION. The term ‘specified manufacturer’ shall not include a manufacturer described in subclause (I) if such manufacturer is acquired after 2021 by another manufacturer that is not a specified manufacturer, effective at the beginning of the plan year immediately following such acquisition or, in the case of an acquisition before 2025, effective January 1, 2025.
1022 183.4 - 183.6 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(B)(iii) SPECIFIED LIS PERCENT. In this subparagraph, the ‘specified LIS percent’ means, with respect to a year
1023 183.7 - 183.16 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(B)(iii)(I) for an applicable drug dispensed for an applicable beneficiary described in clause (i) who has not incurred costs, as determined in accordance with section 1860D–2(b)(4)(C), for covered part D drugs in the year that are equal to or exceed the annual out-of-pocket threshold specified in section 1860D–2(b)(4)(B)(i) for the year
1024 183.17 - 183.17 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(B)(iii)(I)(aa) for 2025, 99 percent;
1025 183.18 - 183.18 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(B)(iii)(I)(bb) for 2026, 98 percent;
1026 183.19 - 183.19 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(B)(iii)(I)(cc) for 2027, 95 percent;
1027 183.20 - 183.21 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(B)(iii)(I)(dd) for 2028, 92 percent; and
1028 183.22 - 183.23 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(B)(iii)(I)(ee) for 2029 and each subsequent year, 90 percent; and
1029 183.24 - 184.8 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(B)(iii)(II) for an applicable drug dispensed for an applicable beneficiary described in clause (i) who has incurred costs, as determined in accordance with section 1860D–2(b)(4)(C), for covered part D drugs in the year that are equal to or exceed the annual out-of-pocket threshold specified in section 1860D–2(b)(4)(B)(i) for the year
1030 184.9 - 184.9 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(B)(iii)(II)(aa) for 2025, 99 percent;
1031 184.10 - 184.10 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(B)(iii)(II)(bb) for 2026, 98 percent;
1032 184.11 - 184.11 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(B)(iii)(II)(cc) for 2027, 95 percent;
1033 184.12 - 184.12 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(B)(iii)(II)(dd) for 2028, 92 percent;
1034 184.13 - 184.13 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(B)(iii)(II)(ee) for 2029, 90 percent;
1035 184.14 - 184.15 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(B)(iii)(II)(ff) for 2030, 85 percent; and
1036 184.16 - 184.17 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(B)(iii)(II)(gg) for 2031 and each subsequent year, 80 percent.
1037 184.18 - 184.19 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(C) PHASE-IN FOR SPECIFIED SMALL MANUFACTURERS.
1038 184.20 - 185.4 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(C)(i) IN GENERAL. In the case of an applicable drug of a specified small manufacturer (as defined in clause (ii)) that is marketed as of the date of enactment of this subparagraph and dispensed for an applicable beneficiary, the term ‘discounted price’ means the specified small manufacturer percent (as defined in clause (iii)) of the negotiated price of the applicable drug of the manufacturer.
1039 185.5 - 185.6 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(C)(ii) SPECIFIED SMALL MANUFACTURER.
1040 185.7 - 185.11 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(C)(ii)(I) IN GENERAL. In this subparagraph, subject to subclause (III), the term ‘specified small manufacturer’ means a manufacturer of an applicable drug for which, in 2021
1041 185.12 - 185.14 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(C)(ii)(I)(aa) the manufacturer is a specified manufacturer (as defined in subparagraph (B)(ii)); and
1042 185.15 - 186.6 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(C)(ii)(I)(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 1860D– 14A 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 this part during such year.
1043 186.7 - 186.8 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(C)(ii)(II) SPECIFIED SMALL MANUFACTURER DRUGS.
1044 186.9 - 186.17 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(C)(ii)(II)(aa) IN GENERAL. For purposes of this clause, 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.
1045 186.18 - 187.6 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(C)(ii)(II)(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.
1046 187.7 - 187.17 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(C)(ii)(III) LIMITATION. The term ‘specified small manufacturer’ shall not include a manufacturer described in subclause (I) if such manufacturer is acquired after 2021 by another manufacturer that is not a specified small manufacturer, effective at the beginning of the plan year immediately following such acquisition or, in the case of an acquisition before 2025, effective January 1, 2025.
1047 187.18 - 187.21 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(C)(iii) SPECIFIED SMALL MANUFACTURER PERCENT. In this subparagraph, the term ‘specified small manufacturer percent’ means, with respect to a year
1048 187.22 - 188.5 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(C)(iii)(I) for an applicable drug dispensed for an applicable beneficiary who has not incurred costs, as determined in accordance with section 1860D–2(b)(4)(C), for covered part D drugs in the year that are equal to or exceed the annual out-of-pocket threshold specified in section 1860D– 2(b)(4)(B)(i) for the year
1049 188.6 - 188.6 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(C)(iii)(I)(aa) for 2025, 99 percent;
1050 188.7 - 188.7 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(C)(iii)(I)(bb) for 2026, 98 percent;
1051 188.8 - 188.8 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(C)(iii)(I)(cc) for 2027, 95 percent;
1052 188.9 - 188.10 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(C)(iii)(I)(dd) for 2028, 92 percent; and
1053 188.11 - 188.12 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(C)(iii)(I)(ee) for 2029 and each subsequent year, 90 percent; and
1054 188.13 - 188.21 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(C)(iii)(II) for an applicable drug dispensed for an applicable beneficiary who has incurred costs, as determined in accordance with section 1860D– 2(b)(4)(C), for covered part D drugs in the year that are equal to or exceed the annual out-of-pocket threshold specified in section 1860D–2(b)(4)(B)(i) for the year
1055 188.22 - 188.22 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(C)(iii)(II)(aa) for 2025, 99 percent;
1056 188.23 - 188.23 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(C)(iii)(II)(bb) for 2026, 98 percent;
1057 188.24 - 188.24 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(C)(iii)(II)(cc) for 2027, 95 percent;
1058 188.25 - 188.25 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(C)(iii)(II)(dd) for 2028, 92 percent;
1059 189.1 - 189.1 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(C)(iii)(II)(ee) for 2029, 90 percent;
1060 189.2 - 189.3 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(C)(iii)(II)(ff) for 2030, 85 percent; and
1061 189.4 - 189.5 [SEC. 11201.(c)(1)] SEC. 1860D–14C.(g)(4)(C)(iii)(II)(gg) for 2031 and each subsequent year, 80 percent.