HR6575-119

2. Extension and modification of enhanced premium tax credit Section 36B(b)(3)(A)(iii) of the Internal Revenue Code of 1986 is amended— by redesignating subclauses (I) and (II) as items (aa) and (bb), respectively, and adjusting the margins accordingly, by striking Temporary percentages for 2021 through 2025.—In the case of and inserting Temporary percentages for certain years.— In the case of by adding at the end the following: In the case of a taxable year beginning after December 31, 2025, and before January 1, 2027— clause (ii) shall not apply for purposes of adjusting premium percentages under this subparagraph, and the following table shall be applied in lieu of the table contained in clause (i): Section 36B(c)(1)(E) of such Code is amended— by striking Temporary rule for 2021 through 2025.—In the case of and inserting Temporary rule for certain years.— In the case of by adding at the end the following: In the case of a taxable year beginning after December 31, 2025, and before January 1, 2027, subparagraph (A) shall be applied by substituting but does not exceed 1000 percent for but does not exceed 400 percent. The amendments made by this section shall apply to taxable years beginning after December 31, 2025. Temporary percentages for certain years.— (I)Before 2026In the case of, and (II)2026In the case of a taxable year beginning after December 31, 2025, and before January 1, 2027— (aa)clause (ii) shall not apply for purposes of adjusting premium percentages under this subparagraph, and (bb)the following table shall be applied in lieu of the table contained in clause (i): In the case of household income (expressed as a percent of poverty line) within the following income tier:The initial premium percentage is-The final premium percentage is- Up to 150%0.0%0.0% 150% up to 200%0.0%2.0% 200% up to 250%2.0%4.0% 250% up to 300%4.0%6.0% 300% up to 400%6.0%8.5% 400% up to 600%8.5%8.5% 600% up to 900%8.5%9.25% 900% up to 1000%9.25%10.0%. Temporary rule for certain years.— (i)Before 2026In the case of, and (ii)2026In the case of a taxable year beginning after December 31, 2025, and before January 1, 2027, subparagraph (A) shall be applied by substituting but does not exceed 1000 percent for but does not exceed 400 percent..

3. Guardrails to prevent fraud in Exchanges Section 1411(h)(1) of the Patient Protection and Affordable Care Act (42 U.S.C. 18081(h)(1)) is amended— in subparagraph (A)— by redesignating clause (ii) as clause (iv); in clause (i)— in the matter preceding subclause (I), by striking If— and all that follows through the such person in the matter following subclause (II) and inserting the following: If any person (other than an agent or broker) fails to provide correct information under subsection (b) and such failure is attributable to negligence or disregard of any rules or regulations of the Secretary, such person; and in the second sentence, by striking For purposes and inserting the following: For purposes by inserting after clause (i) the following: If any agent or broker fails to provide correct information under subsection (b) or section 1311(c)(8) or other information, as specified by the Secretary, and such failure is attributable to negligence or disregard of any rules or regulations of the Secretary, such agent or broker shall be subject, in addition to any other penalties that may be prescribed by law, including subparagraph (C), to a civil penalty of not less than $10,000 and not more than $50,000 with respect to each individual who is the subject of an application for which such incorrect information is provided. in clause (iv) (as so redesignated), by inserting or (ii) after clause (i); in subparagraph (B)— by inserting including subparagraph (C), after law,; by striking Any person and inserting the following: Any person by adding at the end the following: Any agent or broker who knowingly provides false or fraudulent information under subsection (b) or section 1311(c)(8), or other false or fraudulent information as part of an application for enrollment in a qualified health plan offered through an Exchange, as specified by the Secretary, shall be subject, in addition to any other penalties that may be prescribed by law, including subparagraph (C), to a civil penalty of not more than $200,000 with respect to each individual who is the subject of an application for which such false or fraudulent information is provided. The provisions of section 1128A of the Social Security Act (other than subsections (a) and (b) of such section) shall apply to a civil monetary penalty under subclause (I) in the same manner as such provisions apply to a penalty or proceeding under section 1128A of the Social Security Act. by adding at the end the following: Any agent or broker who knowingly and willfully provides false or fraudulent information under subsection (b) or section 1311(c)(8), or other false or fraudulent information as part of an application for enrollment in a qualified health plan offered through an Exchange, as specified by the Secretary, shall be fined under title 18, United States Code, imprisoned for not more than 10 years, or both. Section 1311(c) of the Patient Protection and Affordable Care Act (42 U.S.C. 18031(c)) is amended by adding at the end the following new paragraph: For plan years beginning on or after such date specified by the Secretary, but not later than January 1, 2029, in the case of an Exchange that the Secretary operates pursuant to section 1321(c)(1), the Secretary shall establish a verification process for new enrollments of individuals in, and changes in coverage for individuals under, a qualified health plan offered through such Exchange, which are submitted by an agent or broker in accordance with section 1312(e) and for which the agent or broker is eligible to receive a commission. The enrollment verification process under subparagraph (A) shall include— a requirement that the agent or broker provide with the new enrollment or coverage change such documentation or evidence (such as a standardized consent form) or other sources as the Secretary determines necessary to establish that the agent or broker has the consent of the individual for the new enrollment or coverage change; a requirement that any commissions due to a broker or agent for such new enrollment or coverage change are paid after the enrollee has resolved all inconsistencies in accordance with paragraphs (3) and (4) of section 1411(e); a requirement that the information required under clause (i) and, as applicable, the date on which inconsistencies are resolved as described in clause (ii), is accessible to the applicable qualified health plan through a database or other resource, as determined by the Secretary, so that any commissions due to a broker or agent for such enrollment can be effectuated at the appropriate time; a requirement that individuals are notified of any changes to enrollment, coverage, the agent of record, or premium tax credits in a timely manner and that such notice provides plain language instructions on how individuals can cancel unauthorized activity; a requirement that individuals be able to access their account information on a website or other technology platform, as defined by the Secretary, when used to submit an enrollment or plan change, in lieu of the Exchange website described in subsection (d)(4)(C), including information on the agent of record, the qualified health plan, and when any changes are made to the agent of record or the qualified health plan, on a consumer-facing website or through a toll-free telephone hotline; and a requirement that the agent or broker report to the Secretary any third-party marketing organization or field marketing organization (as such terms are defined in section 1312(e)) involved in the chain of enrollment (as so defined) with respect to such new enrollment or coverage change. The Secretary shall ensure that the enrollment verification process under subparagraph (A) prioritizes continuity of coverage and care for individuals, including by not disenrolling individuals from a qualified health plan without the consent of the individual, regardless of whether the broker, agent, or qualified health plan is in violation of any requirement under this paragraph. Section 1311(c)(1) of the Patient Protection and Affordable Care Act (42 U.S.C. 18031(c)(1)) is amended— in subparagraph (H), by striking and at the end; in subparagraph (I), by striking the period at the end and inserting ; and; and by adding at the end the following: report to the Secretary the termination (as defined in section 1312(e)(1)(C)) of an issuer. Section 1312(e) of the Patient Protection and Affordable Care Act (42 U.S.C. 18032(e)) is amended— by redesignating paragraphs (1) and (2) as subclauses (I) and (II), respectively, and adjusting the margins accordingly; in subclause (II) (as so redesignated), by striking the period at the end and inserting ; and; by striking the subsection designation and heading and all that follows through brokers— and inserting the following: The Secretary shall establish procedures under which a State may allow— agents or brokers— by adding at the end the following: field marketing organizations and third-party marketing organizations to participate in the chain of enrollment for an individual with respect to qualified health plans offered through an Exchange. For plan years beginning on or after such date specified by the Secretary, but not later than January 1, 2029, the Secretary, by regulation, shall establish criteria for States to use in determining whether to allow agents and brokers to enroll individuals and employers in qualified health plans as described in subclause (I) of subparagraph (A)(i) and to assist individuals as described in subclause (II) of such subparagraph and field marketing organizations and third-party marketing organizations to participate in the chain of enrollment as described in subparagraph (A)(ii). Such criteria shall, at a minimum, require that— an agent or broker act in accordance with a standard of conduct that includes a duty of such agent or broker to act in the best interests of the enrollee; a field marketing organization or third-party marketing organization agree to report the termination of an agent or broker to the applicable State and the Secretary, including the reason for termination; and an agent, broker, field marketing organization, or third-party marketing organization— meet such marketing requirements as are required by the Secretary; meet marketing requirements in accordance with other applicable Federal or State law; does not employ practices that are confusing or misleading, as determined by the Secretary; submit all marketing materials to the Secretary for, as determined appropriate by the Secretary, review and approval; is a licensed agent or broker or meets other licensure requirements, as required by the State; register with the Secretary; and does not compensate any individual or organization for referrals or any other service relating to the sale of, marketing for, or enrollment in qualified health plans unless such individual or organization meets the criteria described in subclauses (I) through (VI). In this paragraph: The term chain of enrollment, with respect to enrollment of an individual in a qualified health plan offered through an Exchange, means any steps taken from marketing to such individual, to such individual making an enrollment decision with respect to such a plan. The term field marketing organization means an organization or individual that directly employs or contracts with agents and brokers, or contracts with carriers, to provide functions relating to enrollment of individuals in qualified health plans offered through an Exchange as part of the chain of enrollment. The term marketing means the use of marketing materials to provide information to current and prospective enrollees in a qualified health plan offered through an Exchange. The term marketing materials means materials relating to a qualified health plan offered through an Exchange or benefits offered through an Exchange that— are intended— to draw an individual’s attention to such plan or the premium tax credits or cost-sharing reductions for such plan or plans offered through an Exchange; to influence an individual’s decision-making process when selecting a qualified health plan in which to enroll; or to influence an enrollee’s decision to stay enrolled in such plan; and include or address content regarding the benefits, benefit structure, premiums, or cost sharing of such plan. The term termination, with respect to a contract or business arrangement between an agent or broker and a field marketing organization, third-party marketing organization, or health insurance issuer, means— the ending of such contract or business arrangement, either unilaterally by one of the parties or on mutual agreement; or the expiration of such contract or business arrangement that is not replaced by a substantially similar agreement. The term third-party marketing organization means an organization or individual that is compensated to perform lead generation, marketing, or sales relating to enrollment of individuals in qualified health plans offered through an Exchange as part of the chain of enrollment. Section 1312(e) of the Patient Protection and Affordable Care Act (42 U.S.C. 18032(e)), as amended by paragraph (3), is further amended by adding at the end the following new paragraphs: For plan years beginning on or after such date specified by the Secretary, but not later than January 1, 2029, the Secretary, in coordination with the States and in consultation with the National Association of Insurance Commissioners, shall implement a process for the oversight and enforcement of agent and broker compliance with this section and other applicable Federal and State law (including regulations) that shall include— periodic audits of agents and brokers based on— complaints filed with the Secretary by individuals enrolled by such an agent or broker in a qualified health plan offered through an Exchange; an incident or enrollment pattern that suggests fraud; and other factors determined by the Secretary; and a process under which the Secretary shall share audit results and refer potential cases of fraud to the relevant State department of insurance. Nothing in this paragraph limits or restricts any referrals made under section 1311(i)(3) or any enforcement actions under section 1411(h). The Secretary shall develop a process to regularly provide to qualified health plans, Exchanges, and States a list of suspended and terminated agents and brokers. Section 1311(c) of the Patient Protection and Affordable Care Act (42 U.S.C. 18031(c)), as amended by subsection (a), is further amended by adding at the end the following new paragraph: Not later than 90 days after the date of the enactment of this paragraph, and on a quarterly basis thereafter, the Secretary shall conduct a check of the Death Master File (as such term is defined in section 203(d) of the Bipartisan Budget Act of 2013) for purposes of identifying individuals enrolled in a qualified health plan through an Exchange who are deceased. The Secretary shall— establish a process to verify that an individual identified pursuant to a check described in subparagraph (A) is deceased; and require an Exchange to terminate such individual’s enrollment under a qualified health plan. Section 1312(e) of the Patient Protection and Affordable Care Act (42 U.S.C. 18032(e)), as amended by subsection (a), is further amended by adding at the end the following new paragraph: In the case of an agent or broker with an agreement in effect with an Exchange operated by the Secretary pursuant to section 1321(c) to perform activities described in paragraph (1)(A)(i) with respect to such Exchange, the Secretary may terminate such agreement if the Secretary finds, based on a preponderance of the evidence, that such agent or broker has violated such agreement, otherwise applicable law, or any other requirement applicable to such agent or broker. Section 1412(c)(2) of the Patient Protection and Affordable Care Act (42 U.S.C. 18082(c)(2)) is amended by adding at the end the following new subparagraph: Beginning January 1, 2027, if an Exchange is notified under paragraph (1) of an advance determination under section 1411 with respect to the eligibility of an individual for a premium tax credit under section 36B of the Internal Revenue Code of 1986, the Exchange shall, prior to enrolling such individual in a qualified health plan, clearly notify such individual of the amount of such tax credit. (iii)Definitions of negligence, disregardFor purposes; (ii)Civil penalties for certain violations by agents or brokersIf any agent or broker fails to provide correct information under subsection (b) or section 1311(c)(8) or other information, as specified by the Secretary, and such failure is attributable to negligence or disregard of any rules or regulations of the Secretary, such agent or broker shall be subject, in addition to any other penalties that may be prescribed by law, including subparagraph (C), to a civil penalty of not less than $10,000 and not more than $50,000 with respect to each individual who is the subject of an application for which such incorrect information is provided. ; and (i)In generalAny person; and (ii)Civil penalties for knowing violations by agents or brokers (I)In generalAny agent or broker who knowingly provides false or fraudulent information under subsection (b) or section 1311(c)(8), or other false or fraudulent information as part of an application for enrollment in a qualified health plan offered through an Exchange, as specified by the Secretary, shall be subject, in addition to any other penalties that may be prescribed by law, including subparagraph (C), to a civil penalty of not more than $200,000 with respect to each individual who is the subject of an application for which such false or fraudulent information is provided. (II)ProcedureThe provisions of section 1128A of the Social Security Act (other than subsections (a) and (b) of such section) shall apply to a civil monetary penalty under subclause (I) in the same manner as such provisions apply to a penalty or proceeding under section 1128A of the Social Security Act.; and (C)Criminal penaltiesAny agent or broker who knowingly and willfully provides false or fraudulent information under subsection (b) or section 1311(c)(8), or other false or fraudulent information as part of an application for enrollment in a qualified health plan offered through an Exchange, as specified by the Secretary, shall be fined under title 18, United States Code, imprisoned for not more than 10 years, or both.. (8)Agent- or broker-assisted enrollment in qualified health plans in certain exchanges (A)In generalFor plan years beginning on or after such date specified by the Secretary, but not later than January 1, 2029, in the case of an Exchange that the Secretary operates pursuant to section 1321(c)(1), the Secretary shall establish a verification process for new enrollments of individuals in, and changes in coverage for individuals under, a qualified health plan offered through such Exchange, which are submitted by an agent or broker in accordance with section 1312(e) and for which the agent or broker is eligible to receive a commission. (B)RequirementsThe enrollment verification process under subparagraph (A) shall include— (i)a requirement that the agent or broker provide with the new enrollment or coverage change such documentation or evidence (such as a standardized consent form) or other sources as the Secretary determines necessary to establish that the agent or broker has the consent of the individual for the new enrollment or coverage change; (ii)a requirement that any commissions due to a broker or agent for such new enrollment or coverage change are paid after the enrollee has resolved all inconsistencies in accordance with paragraphs (3) and (4) of section 1411(e); (iii)a requirement that the information required under clause (i) and, as applicable, the date on which inconsistencies are resolved as described in clause (ii), is accessible to the applicable qualified health plan through a database or other resource, as determined by the Secretary, so that any commissions due to a broker or agent for such enrollment can be effectuated at the appropriate time; (iv)a requirement that individuals are notified of any changes to enrollment, coverage, the agent of record, or premium tax credits in a timely manner and that such notice provides plain language instructions on how individuals can cancel unauthorized activity; (v)a requirement that individuals be able to access their account information on a website or other technology platform, as defined by the Secretary, when used to submit an enrollment or plan change, in lieu of the Exchange website described in subsection (d)(4)(C), including information on the agent of record, the qualified health plan, and when any changes are made to the agent of record or the qualified health plan, on a consumer-facing website or through a toll-free telephone hotline; and (vi)a requirement that the agent or broker report to the Secretary any third-party marketing organization or field marketing organization (as such terms are defined in section 1312(e)) involved in the chain of enrollment (as so defined) with respect to such new enrollment or coverage change. (C)Consumer protectionThe Secretary shall ensure that the enrollment verification process under subparagraph (A) prioritizes continuity of coverage and care for individuals, including by not disenrolling individuals from a qualified health plan without the consent of the individual, regardless of whether the broker, agent, or qualified health plan is in violation of any requirement under this paragraph.. (J)report to the Secretary the termination (as defined in section 1312(e)(1)(C)) of an issuer.. (e)Regulation of agents, brokers, and certain marketing organizations (1)Agents, brokers, and certain marketing organizations (A)In generalThe Secretary shall establish procedures under which a State may allow— (i)agents or brokers—; and (ii)field marketing organizations and third-party marketing organizations to participate in the chain of enrollment for an individual with respect to qualified health plans offered through an Exchange. (B)CriteriaFor plan years beginning on or after such date specified by the Secretary, but not later than January 1, 2029, the Secretary, by regulation, shall establish criteria for States to use in determining whether to allow agents and brokers to enroll individuals and employers in qualified health plans as described in subclause (I) of subparagraph (A)(i) and to assist individuals as described in subclause (II) of such subparagraph and field marketing organizations and third-party marketing organizations to participate in the chain of enrollment as described in subparagraph (A)(ii). Such criteria shall, at a minimum, require that— (i)an agent or broker act in accordance with a standard of conduct that includes a duty of such agent or broker to act in the best interests of the enrollee; (ii)a field marketing organization or third-party marketing organization agree to report the termination of an agent or broker to the applicable State and the Secretary, including the reason for termination; and (iii)an agent, broker, field marketing organization, or third-party marketing organization— (I)meet such marketing requirements as are required by the Secretary; (II)meet marketing requirements in accordance with other applicable Federal or State law; (III)does not employ practices that are confusing or misleading, as determined by the Secretary; (IV)submit all marketing materials to the Secretary for, as determined appropriate by the Secretary, review and approval; (V)is a licensed agent or broker or meets other licensure requirements, as required by the State; (VI)register with the Secretary; and (VII)does not compensate any individual or organization for referrals or any other service relating to the sale of, marketing for, or enrollment in qualified health plans unless such individual or organization meets the criteria described in subclauses (I) through (VI). (C)DefinitionsIn this paragraph: (i)Chain of enrollmentThe term chain of enrollment, with respect to enrollment of an individual in a qualified health plan offered through an Exchange, means any steps taken from marketing to such individual, to such individual making an enrollment decision with respect to such a plan. (ii)Field marketing organizationThe term field marketing organization means an organization or individual that directly employs or contracts with agents and brokers, or contracts with carriers, to provide functions relating to enrollment of individuals in qualified health plans offered through an Exchange as part of the chain of enrollment. (iii)MarketingThe term marketing means the use of marketing materials to provide information to current and prospective enrollees in a qualified health plan offered through an Exchange. (iv)Marketing materialsThe term marketing materials means materials relating to a qualified health plan offered through an Exchange or benefits offered through an Exchange that— (I)are intended— (aa)to draw an individual’s attention to such plan or the premium tax credits or cost-sharing reductions for such plan or plans offered through an Exchange; (bb)to influence an individual’s decision-making process when selecting a qualified health plan in which to enroll; or (cc)to influence an enrollee’s decision to stay enrolled in such plan; and (II)include or address content regarding the benefits, benefit structure, premiums, or cost sharing of such plan. (v)TerminationThe term termination, with respect to a contract or business arrangement between an agent or broker and a field marketing organization, third-party marketing organization, or health insurance issuer, means— (I)the ending of such contract or business arrangement, either unilaterally by one of the parties or on mutual agreement; or (II)the expiration of such contract or business arrangement that is not replaced by a substantially similar agreement. (vi)Third-party marketing organizationThe term third-party marketing organization means an organization or individual that is compensated to perform lead generation, marketing, or sales relating to enrollment of individuals in qualified health plans offered through an Exchange as part of the chain of enrollment.. (2)Audits (A)In generalFor plan years beginning on or after such date specified by the Secretary, but not later than January 1, 2029, the Secretary, in coordination with the States and in consultation with the National Association of Insurance Commissioners, shall implement a process for the oversight and enforcement of agent and broker compliance with this section and other applicable Federal and State law (including regulations) that shall include— (i)periodic audits of agents and brokers based on— (I)complaints filed with the Secretary by individuals enrolled by such an agent or broker in a qualified health plan offered through an Exchange; (II)an incident or enrollment pattern that suggests fraud; and (III)other factors determined by the Secretary; and (ii)a process under which the Secretary shall share audit results and refer potential cases of fraud to the relevant State department of insurance. (B)EffectNothing in this paragraph limits or restricts any referrals made under section 1311(i)(3) or any enforcement actions under section 1411(h). (3)ListThe Secretary shall develop a process to regularly provide to qualified health plans, Exchanges, and States a list of suspended and terminated agents and brokers.. (9)Removal of deceased individuals from Exchange plans (A)In generalNot later than 90 days after the date of the enactment of this paragraph, and on a quarterly basis thereafter, the Secretary shall conduct a check of the Death Master File (as such term is defined in section 203(d) of the Bipartisan Budget Act of 2013) for purposes of identifying individuals enrolled in a qualified health plan through an Exchange who are deceased. (B)ProcessThe Secretary shall— (i)establish a process to verify that an individual identified pursuant to a check described in subparagraph (A) is deceased; and (ii)require an Exchange to terminate such individual’s enrollment under a qualified health plan.. (4)Standard for termination for certain ExchangesIn the case of an agent or broker with an agreement in effect with an Exchange operated by the Secretary pursuant to section 1321(c) to perform activities described in paragraph (1)(A)(i) with respect to such Exchange, the Secretary may terminate such agreement if the Secretary finds, based on a preponderance of the evidence, that such agent or broker has violated such agreement, otherwise applicable law, or any other requirement applicable to such agent or broker.. (C)Exchange responsibilitiesBeginning January 1, 2027, if an Exchange is notified under paragraph (1) of an advance determination under section 1411 with respect to the eligibility of an individual for a premium tax credit under section 36B of the Internal Revenue Code of 1986, the Exchange shall, prior to enrolling such individual in a qualified health plan, clearly notify such individual of the amount of such tax credit..

4. Extending annual open enrollment period for Exchanges for plan year 2026 The Secretary of Health and Human Services shall revise section 155.410(e) of title 45, Code of Federal Regulations (or any successor regulation) to provide that the annual open enrollment period determined for plan year 2026 pursuant to section 1311(c)(6) of the Patient Protection and Affordable Care Act (42 U.S.C. 18031(c)(6)) shall begin on November 1, 2025, and end on March 19, 2026. The Secretary of Health and Human Services shall perform such outreach activities as are necessary to inform qualified individuals (as defined in section 1312(f)(1) of the Patient Protection and Affordable Care Act (42 U.S.C. 18032(f)(1))) of the extended open enrollment period provided for under subsection (a).

5. Modernizing and Ensuring PBM Accountability Section 1860D–12 of the Social Security Act (42 U.S.C. 1395w–112) is amended by adding at the end the following new subsection: For plan years beginning on or after January 1, 2029: Each contract entered into with a PDP sponsor under this part with respect to a prescription drug plan offered by such sponsor shall provide that any pharmacy benefit manager acting on behalf of such sponsor has a written agreement with the PDP sponsor under which the pharmacy benefit manager, and any affiliates of such pharmacy benefit manager, as applicable, agree to meet the following requirements: The pharmacy benefit manager and any affiliate of such pharmacy benefit manager shall not derive any remuneration with respect to any services provided on behalf of any entity or individual, in connection with the utilization of covered part D drugs, from any such entity or individual other than bona fide service fees, subject to clauses (ii) and (iii). For the purposes of this subsection, an incentive payment (as determined by the Secretary) paid by a PDP sponsor to a pharmacy benefit manager that is performing services on behalf of such sponsor shall be deemed a bona fide service fee (even if such payment does not otherwise meet the definition of such term under paragraph (7)(B)) if such payment is a flat dollar amount, is consistent with fair market value (as specified by the Secretary), is related to services actually performed by the pharmacy benefit manager or affiliate of such pharmacy benefit manager, on behalf of the PDP sponsor making such payment, in connection with the utilization of covered part D drugs, and meets additional requirements, if any, as determined appropriate by the Secretary. Rebates, discounts, and other price concessions received by a pharmacy benefit manager or an affiliate of a pharmacy benefit manager from manufacturers, even if such price concessions are calculated as a percentage of a drug’s price, shall not be considered a violation of the requirements of clause (i) if they are fully passed through to a PDP sponsor and are compliant with all regulatory and subregulatory requirements related to direct and indirect remuneration for manufacturer rebates under this part, including in cases where a PDP sponsor is acting as a pharmacy benefit manager on behalf of a prescription drug plan offered by such PDP sponsor. Components of subsets of remuneration arrangements (such as fees or other forms of compensation paid to or retained by the pharmacy benefit manager or affiliate of such pharmacy benefit manager), as determined appropriate by the Secretary, between pharmacy benefit managers or affiliates of such pharmacy benefit managers, as applicable, and other entities involved in the dispensing or utilization of covered part D drugs (including PDP sponsors, manufacturers, pharmacies, and other entities as determined appropriate by the Secretary) shall be subject to review by the Secretary, in consultation with the Office of the Inspector General of the Department of Health and Human Services, as determined appropriate by the Secretary. The Secretary, in consultation with the Office of the Inspector General, shall review whether remuneration under such arrangements is consistent with fair market value (as specified by the Secretary) through reviews and assessments of such remuneration, as determined appropriate. The pharmacy benefit manager shall disgorge any remuneration paid to such pharmacy benefit manager or an affiliate of such pharmacy benefit manager in violation of this subparagraph to the PDP sponsor. The pharmacy benefit manager shall— enter into a written agreement with any affiliate of such pharmacy benefit manager, under which the affiliate shall identify and disgorge any remuneration described in clause (v) to the pharmacy benefit manager; and attest, subject to any requirements determined appropriate by the Secretary, that the pharmacy benefit manager has entered into a written agreement described in subclause (I) with any relevant affiliate of the pharmacy benefit manager. The pharmacy benefit manager shall— define, interpret, and apply, in a fully transparent and consistent manner for purposes of calculating or otherwise evaluating pharmacy benefit manager performance against pricing guarantees or similar cost performance measurements related to rebates, discounts, price concessions, or net costs, terms such as— generic drug, in a manner consistent with the definition of the term under section 423.4 of title 42, Code of Federal Regulations, or a successor regulation; brand name drug, in a manner consistent with the definition of the term under section 423.4 of title 42, Code of Federal Regulations, or a successor regulation; specialty drug; rebate; and discount; identify any drugs, claims, or price concessions excluded from any pricing guarantee or other cost performance measure in a clear and consistent manner; and where a pricing guarantee or other cost performance measure is based on a pricing benchmark other than the wholesale acquisition cost (as defined in section 1847A(c)(6)(B)) of a drug, calculate and provide a wholesale acquisition cost-based equivalent to the pricing guarantee or other cost performance measure. Not later than July 1 of each year, beginning in 2029, the pharmacy benefit manager shall submit to the PDP sponsor, and to the Secretary, a report, in accordance with this subparagraph, and shall make such report available to such sponsor at no cost to such sponsor in a format specified by the Secretary under paragraph (5). Each such report shall include, with respect to such PDP sponsor and each plan offered by such sponsor, the following information with respect to the previous plan year: A list of all drugs covered by the plan that were dispensed including, with respect to each such drug— the brand name, generic or non-proprietary name, and National Drug Code; the number of plan enrollees for whom the drug was dispensed, the total number of prescription claims for the drug (including original prescriptions and refills, counted as separate claims), and the total number of dosage units of the drug dispensed; the number of prescription claims described in item (bb) by each type of dispensing channel through which the drug was dispensed, including retail, mail order, specialty pharmacy, long term care pharmacy, home infusion pharmacy, or other types of pharmacies or providers; the average wholesale acquisition cost, listed as cost per day’s supply, cost per dosage unit, and cost per typical course of treatment (as applicable); the average wholesale price for the drug, listed as price per day’s supply, price per dosage unit, and price per typical course of treatment (as applicable); the total out-of-pocket spending by plan enrollees on such drug after application of any benefits under the plan, including plan enrollee spending through copayments, coinsurance, and deductibles; total rebates paid by the manufacturer on the drug as reported under the Detailed DIR Report (or any successor report) submitted by such sponsor to the Centers for Medicare & Medicaid Services; all other direct or indirect remuneration on the drug as reported under the Detailed DIR Report (or any successor report) submitted by such sponsor to the Centers for Medicare & Medicaid Services; the average pharmacy reimbursement amount paid by the plan for the drug in the aggregate and disaggregated by dispensing channel identified in item (cc); the average National Average Drug Acquisition Cost (NADAC); and total manufacturer-derived revenue, inclusive of bona fide service fees, attributable to the drug and retained by the pharmacy benefit manager and any affiliate of such pharmacy benefit manager. In the case of a pharmacy benefit manager that has an affiliate that is a retail, mail order, or specialty pharmacy, with respect to drugs covered by such plan that were dispensed, the following information: The percentage of total prescriptions that were dispensed by pharmacies that are an affiliate of the pharmacy benefit manager for each drug. The interquartile range of the total combined costs paid by the plan and plan enrollees, per dosage unit, per course of treatment, per 30-day supply, and per 90-day supply for each drug dispensed by pharmacies that are not an affiliate of the pharmacy benefit manager and that are included in the pharmacy network of such plan. The interquartile range of the total combined costs paid by the plan and plan enrollees, per dosage unit, per course of treatment, per 30-day supply, and per 90-day supply for each drug dispensed by pharmacies that are an affiliate of the pharmacy benefit manager and that are included in the pharmacy network of such plan. The lowest total combined cost paid by the plan and plan enrollees, per dosage unit, per course of treatment, per 30-day supply, and per 90-day supply, for each drug that is available from any pharmacy included in the pharmacy network of such plan. The difference between the average acquisition cost of the affiliate, such as a pharmacy or other entity that acquires prescription drugs, that initially acquires the drug and the amount reported under subclause (I)(jj) for each drug. A list inclusive of the brand name, generic or non-proprietary name, and National Drug Code of covered part D drugs subject to an agreement with a covered entity under section 340B of the Public Health Service Act for which the pharmacy benefit manager or an affiliate of the pharmacy benefit manager had a contract or other arrangement with such a covered entity in the service area of such plan. Where a drug approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act (referred to in this subclause as the listed drug) is covered by the plan, the following information: A list of currently marketed generic drugs approved under section 505(j) of the Federal Food, Drug, and Cosmetic Act pursuant to an application that references such listed drug that are not covered by the plan, are covered on the same formulary tier or a formulary tier typically associated with higher cost-sharing than the listed drug, or are subject to utilization management that the listed drug is not subject to. The estimated average beneficiary cost-sharing under the plan for a 30-day supply of the listed drug. Where a generic drug listed under item (aa) is on a formulary tier typically associated with higher cost-sharing than the listed drug, the estimated average cost-sharing that a beneficiary would have paid for a 30-day supply of each of the generic drugs described in item (aa), had the plan provided coverage for such drugs on the same formulary tier as the listed drug. A written justification for providing more favorable coverage of the listed drug than the generic drugs described in item (aa). The number of currently marketed generic drugs approved under section 505(j) of the Federal Food, Drug, and Cosmetic Act pursuant to an application that references such listed drug. Where a reference product (as defined in section 351(i) of the Public Health Service Act) is covered by the plan, the following information: A list of currently marketed biosimilar biological products licensed under section 351(k) of the Public Health Service Act pursuant to an application that refers to such reference product that are not covered by the plan, are covered on the same formulary tier or a formulary tier typically associated with higher cost-sharing than the reference product, or are subject to utilization management that the reference product is not subject to. The estimated average beneficiary cost-sharing under the plan for a 30-day supply of the reference product. Where a biosimilar biological product listed under item (aa) is on a formulary tier typically associated with higher cost-sharing than the reference product, the estimated average cost-sharing that a beneficiary would have paid for a 30-day supply of each of the biosimilar biological products described in item (aa), had the plan provided coverage for such products on the same formulary tier as the reference product. A written justification for providing more favorable coverage of the reference product than the biosimilar biological product described in item (aa). The number of currently marketed biosimilar biological products licensed under section 351(k) of the Public Health Service Act, pursuant to an application that refers to such reference product. Total gross spending on covered part D drugs by the plan, not net of rebates, fees, discounts, or other direct or indirect remuneration. The total amount retained by the pharmacy benefit manager or an affiliate of such pharmacy benefit manager in revenue related to utilization of covered part D drugs under that plan, inclusive of bona fide service fees. The total spending on covered part D drugs net of rebates, fees, discounts, or other direct and indirect remuneration by the plan. An explanation of any benefit design parameters under such plan that encourage plan enrollees to fill prescriptions at pharmacies that are an affiliate of such pharmacy benefit manager, such as mail and specialty home delivery programs, and retail and mail auto-refill programs. The following information: A list of all brokers, consultants, advisors, and auditors that receive compensation from the pharmacy benefit manager or an affiliate of such pharmacy benefit manager for referrals, consulting, auditing, or other services offered to PDP sponsors related to pharmacy benefit management services. The amount of compensation provided by such pharmacy benefit manager or affiliate to each such broker, consultant, advisor, and auditor. The methodology for calculating the amount of compensation provided by such pharmacy benefit manager or affiliate, for each such broker, consultant, advisor, and auditor. A list of all affiliates of the pharmacy benefit manager. A summary document submitted in a standardized template developed by the Secretary that includes such information described in subclauses (I) through (X). The pharmacy benefit manager shall, not later than 30 days after the finalization of any contract or agreement between such pharmacy benefit manager or an affiliate of such pharmacy benefit manager and a drug manufacturer (or subsidiary, agent, or entity affiliated with such drug manufacturer) that makes rebates, discounts, payments, or other financial incentives related to one or more covered part D drugs or other prescription drugs, as applicable, of the manufacturer directly or indirectly contingent upon coverage, formulary placement, or utilization management conditions on any other covered part D drugs or other prescription drugs, as applicable, submit to the PDP sponsor a written explanation of such contract or agreement. A written explanation under subclause (I) shall— include the manufacturer subject to the contract or agreement, all covered part D drugs and other prescription drugs, as applicable, subject to the contract or agreement and the manufacturers of such drugs, and a high-level description of the terms of such contract or agreement and how such terms apply to such drugs; and be certified by the Chief Executive Officer, Chief Financial Officer, or General Counsel of such pharmacy benefit manager, or affiliate of such pharmacy benefit manager, as applicable, or an individual delegated with the authority to sign on behalf of one of these officers, who reports directly to the officer. For purposes of this clause, the term other prescription drugs means prescription drugs covered as supplemental benefits under this part or prescription drugs paid outside of this part. Not less than once a year, at the request of the PDP sponsor, the pharmacy benefit manager shall allow for an audit of the pharmacy benefit manager to ensure compliance with all terms and conditions under the written agreement described in this paragraph and the accuracy of information reported under subparagraph (C). The PDP sponsor shall have the right to select an auditor. The pharmacy benefit manager shall not impose any limitations on the selection of such auditor. The pharmacy benefit manager shall make available to such auditor all records, data, contracts, and other information necessary to confirm the accuracy of information provided under subparagraph (C), subject to reasonable restrictions on how such information must be reported to prevent redisclosure of such information. The pharmacy benefit manager must provide information under clause (iii) and other information, data, and records relevant to the audit to such auditor within 6 months of the initiation of the audit and respond to requests for additional information from such auditor within 30 days after the request for additional information. The pharmacy benefit manager shall be responsible for providing to such auditor information required to be reported under subparagraph (C) or under clause (iii) of this subparagraph that is owned or held by an affiliate of such pharmacy benefit manager. Each PDP sponsor shall— disgorge to the Secretary any amounts disgorged to the PDP sponsor by a pharmacy benefit manager under paragraph (1)(A)(v); require, in a written agreement with any pharmacy benefit manager acting on behalf of such sponsor or affiliate of such pharmacy benefit manager, that such pharmacy benefit manager or affiliate reimburse the PDP sponsor for any civil money penalty imposed on the PDP sponsor as a result of the failure of the pharmacy benefit manager or affiliate to meet the requirements of paragraph (1) that are applicable to the pharmacy benefit manager or affiliate under the agreement; and require, in a written agreement with any such pharmacy benefit manager acting on behalf of such sponsor or affiliate of such pharmacy benefit manager, that such pharmacy benefit manager or affiliate be subject to punitive remedies for breach of contract for failure to comply with the requirements applicable under paragraph (1). The Secretary shall make available and maintain a mechanism for manufacturers, PDP sponsors, pharmacies, and other entities that have contractual relationships with pharmacy benefit managers or affiliates of such pharmacy benefit managers to report, on a confidential basis, alleged violations of paragraph (1)(A) or subparagraph (C). Consistent with applicable Federal or State law, a PDP sponsor shall not— retaliate against an individual or entity for reporting an alleged violation under subparagraph (B); or coerce, intimidate, threaten, or interfere with the ability of an individual or entity to report any such alleged violations. Each PDP sponsor shall furnish to the Secretary (at a time and in a manner specified by the Secretary) an annual certification of compliance with this subsection, as well as such information as the Secretary determines necessary to carry out this subsection. Notwithstanding any other provision of law, the Secretary may implement this paragraph by program instruction or otherwise. Nothing in this subsection shall be construed as— prohibiting flat dispensing fees or reimbursement or payment for ingredient costs (including customary, industry-standard discounts directly related to drug acquisition that are retained by pharmacies or wholesalers) to entities that acquire or dispense prescription drugs; or modifying regulatory requirements or sub-regulatory program instruction or guidance related to pharmacy payment, reimbursement, or dispensing fees. Not later than June 1, 2028, the Secretary shall specify standard, machine-readable formats for pharmacy benefit managers to submit annual reports required under paragraph (1)(C)(i). Notwithstanding any other provision of law, the Secretary may implement this paragraph by program instruction or otherwise. Information disclosed by a pharmacy benefit manager, an affiliate of a pharmacy benefit manager, a PDP sponsor, or a pharmacy under this subsection that is not otherwise publicly available or available for purchase shall not be disclosed by the Secretary or a PDP sponsor receiving the information, except that the Secretary may disclose the information for the following purposes: As the Secretary determines necessary to carry out this part. To permit the Comptroller General to review the information provided. To permit the Director of the Congressional Budget Office to review the information provided. To permit the Executive Director of the Medicare Payment Advisory Commission to review the information provided. To the Attorney General for the purposes of conducting oversight and enforcement under this title. To the Inspector General of the Department of Health and Human Services in accordance with its authorities under the Inspector General Act of 1978 (section 406 of title 5, United States Code), and other applicable statutes. The Secretary, the Comptroller General, the Director of the Congressional Budget Office, and the Executive Director of the Medicare Payment Advisory Commission shall not report on or disclose information disclosed pursuant to subparagraph (A) to the public in a manner that would identify— a specific pharmacy benefit manager, affiliate, pharmacy, manufacturer, wholesaler, PDP sponsor, or plan; or contract prices, rebates, discounts, or other remuneration for specific drugs in a manner that may allow the identification of specific contracting parties or of such specific drugs. For purposes of this subsection: The term affiliate means, with respect to any pharmacy benefit manager or PDP sponsor, any entity that, directly or indirectly— owns or is owned by, controls or is controlled by, or is otherwise related in any ownership structure to such pharmacy benefit manager or PDP sponsor; or acts as a contractor, principal, or agent to such pharmacy benefit manager or PDP sponsor, insofar as such contractor, principal, or agent performs any of the functions described under subparagraph (C). The term bona fide service fee means a fee that is reflective of the fair market value (as specified by the Secretary, through notice and comment rulemaking) for a bona fide, itemized service actually performed on behalf of an entity, that the entity would otherwise perform (or contract for) in the absence of the service arrangement and that is not passed on in whole or in part to a client or customer, whether or not the entity takes title to the drug. Such fee must be a flat dollar amount and shall not be directly or indirectly based on, or contingent upon— drug price, such as wholesale acquisition cost or drug benchmark price (such as average wholesale price); the amount of discounts, rebates, fees, or other direct or indirect remuneration with respect to covered part D drugs dispensed to enrollees in a prescription drug plan, except as permitted pursuant to paragraph (1)(A)(ii); coverage or formulary placement decisions or the volume or value of any referrals or business generated between the parties to the arrangement; or any other amounts or methodologies prohibited by the Secretary. The term pharmacy benefit manager means any person or entity that, either directly or through an intermediary, acts as a price negotiator or group purchaser on behalf of a PDP sponsor or prescription drug plan, or manages the prescription drug benefits provided by such sponsor or plan, including the processing and payment of claims for prescription drugs, the performance of drug utilization review, the processing of drug prior authorization requests, the adjudication of appeals or grievances related to the prescription drug benefit, contracting with network pharmacies, controlling the cost of covered part D drugs, or the provision of related services. Such term includes any person or entity that carries out one or more of the activities described in the preceding sentence, irrespective of whether such person or entity calls itself a pharmacy benefit manager. 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: For plan years beginning on or after January 1, 2029, section 1860D–12(h). Chapter 35 of title 44, United States Code, shall not apply to the implementation of this subsection. In addition to amounts otherwise available, there is appropriated to the Centers for Medicare & Medicaid Services Program Management Account, out of any money in the Treasury not otherwise appropriated, $113,000,000 for fiscal year 2026, to remain available until expended, to carry out this subsection. In addition to amounts otherwise available, there is appropriated to the Inspector General of the Department of Health and Human Services, out of any money in the Treasury not otherwise appropriated, $20,000,000 for fiscal year 2026, to remain available until expended, to carry out this subsection. The Comptroller General of the United States (in this subsection referred to as the Comptroller General) shall conduct a study describing the use of compensation and payment structures related to a prescription drug’s price within the retail prescription drug supply chain in part D of title XVIII of the Social Security Act (42 U.S.C. 1395w–101 et seq.). Such study shall summarize information from Federal agencies and industry experts, to the extent available, with respect to the following: The type, magnitude, other features (such as the pricing benchmarks used), and prevalence of compensation and payment structures related to a prescription drug’s price, such as calculating fee amounts as a percentage of a prescription drug’s price, between intermediaries in the prescription drug supply chain, including— pharmacy benefit managers; PDP sponsors offering prescription drug plans and Medicare Advantage organizations offering MA–PD plans; drug wholesalers; pharmacies; manufacturers; pharmacy services administrative organizations; brokers, auditors, consultants, and other entities that— advise PDP sponsors offering prescription drug plans and Medicare Advantage organizations offering MA–PD plans regarding pharmacy benefits; or review PDP sponsor and Medicare Advantage organization contracts with pharmacy benefit managers; and other service providers that contract with any of the entities described in clauses (i) through (vii) that may use price-related compensation and payment structures, such as rebate aggregators (or other entities that negotiate or process price concessions on behalf of pharmacy benefit managers, plan sponsors, or pharmacies). The primary business models and compensation structures for each category of intermediary described in subparagraph (A). Variation in price-related compensation structures between affiliated entities (such as entities with common ownership, either full or partial, and subsidiary relationships) and unaffiliated entities. Potential conflicts of interest among contracting entities related to the use of prescription drug price-related compensation structures, such as the potential for fees or other payments set as a percentage of a prescription drug’s price to advantage formulary selection, distribution, or purchasing of prescription drugs with higher prices. Notable differences, if any, in the use and level of price-based compensation structures over time and between different market segments, such as under part D of title XVIII of the Social Security Act (42 U.S.C. 1395w–101 et seq.) and the Medicaid program under title XIX of such Act (42 U.S.C. 1396 et seq.). The effects of drug price-related compensation structures and alternative compensation structures on Federal health care programs and program beneficiaries, including with respect to cost-sharing, premiums, Federal outlays, biosimilar and generic drug adoption and utilization, drug shortage risks, and the potential for fees set as a percentage of a drug’s price to advantage the formulary selection, distribution, or purchasing of drugs with higher prices. Other issues determined to be relevant and appropriate by the Comptroller General. Not later than 2 years after the date of enactment of this section, the Comptroller General shall submit to Congress a report containing the results of the study conducted under paragraph (1), together with recommendations for such legislation and administrative action as the Comptroller General determines appropriate. The Medicare Payment Advisory Commission shall submit to Congress the following reports: Not later than the first March 15 occurring after the date that is 2 years after the date on which the Secretary makes the data available to the Commission, a report regarding agreements with pharmacy benefit managers with respect to prescription drug plans and MA–PD plans. Such report shall include, to the extent practicable— a description of trends and patterns, including relevant averages, totals, and other figures for the types of information submitted; an analysis of any differences in agreements and their effects on plan enrollee out-of-pocket spending and average pharmacy reimbursement, and other impacts; and any recommendations the Commission determines appropriate. Not later than 2 years after the date on which the Commission submits the initial report under subparagraph (A), a report describing any changes with respect to the information described in subparagraph (A) over time, together with any recommendations the Commission determines appropriate. In addition to amounts otherwise available, there is appropriated to the Medicare Payment Advisory Commission, out of any money in the Treasury not otherwise appropriated, $1,000,000 for fiscal year 2026, to remain available until expended, to carry out this subsection. (h)Requirements relating to pharmacy benefit managersFor plan years beginning on or after January 1, 2029: (1)Agreements with pharmacy benefit managersEach contract entered into with a PDP sponsor under this part with respect to a prescription drug plan offered by such sponsor shall provide that any pharmacy benefit manager acting on behalf of such sponsor has a written agreement with the PDP sponsor under which the pharmacy benefit manager, and any affiliates of such pharmacy benefit manager, as applicable, agree to meet the following requirements: (A)No income other than bona fide service fees (i)In generalThe pharmacy benefit manager and any affiliate of such pharmacy benefit manager shall not derive any remuneration with respect to any services provided on behalf of any entity or individual, in connection with the utilization of covered part D drugs, from any such entity or individual other than bona fide service fees, subject to clauses (ii) and (iii). (ii)Incentive paymentsFor the purposes of this subsection, an incentive payment (as determined by the Secretary) paid by a PDP sponsor to a pharmacy benefit manager that is performing services on behalf of such sponsor shall be deemed a bona fide service fee (even if such payment does not otherwise meet the definition of such term under paragraph (7)(B)) if such payment is a flat dollar amount, is consistent with fair market value (as specified by the Secretary), is related to services actually performed by the pharmacy benefit manager or affiliate of such pharmacy benefit manager, on behalf of the PDP sponsor making such payment, in connection with the utilization of covered part D drugs, and meets additional requirements, if any, as determined appropriate by the Secretary. (iii)Clarification on rebates and discounts used to lower costs for covered part d drugsRebates, discounts, and other price concessions received by a pharmacy benefit manager or an affiliate of a pharmacy benefit manager from manufacturers, even if such price concessions are calculated as a percentage of a drug’s price, shall not be considered a violation of the requirements of clause (i) if they are fully passed through to a PDP sponsor and are compliant with all regulatory and subregulatory requirements related to direct and indirect remuneration for manufacturer rebates under this part, including in cases where a PDP sponsor is acting as a pharmacy benefit manager on behalf of a prescription drug plan offered by such PDP sponsor. (iv)Evaluation of remuneration arrangementsComponents of subsets of remuneration arrangements (such as fees or other forms of compensation paid to or retained by the pharmacy benefit manager or affiliate of such pharmacy benefit manager), as determined appropriate by the Secretary, between pharmacy benefit managers or affiliates of such pharmacy benefit managers, as applicable, and other entities involved in the dispensing or utilization of covered part D drugs (including PDP sponsors, manufacturers, pharmacies, and other entities as determined appropriate by the Secretary) shall be subject to review by the Secretary, in consultation with the Office of the Inspector General of the Department of Health and Human Services, as determined appropriate by the Secretary. The Secretary, in consultation with the Office of the Inspector General, shall review whether remuneration under such arrangements is consistent with fair market value (as specified by the Secretary) through reviews and assessments of such remuneration, as determined appropriate. (v)DisgorgementThe pharmacy benefit manager shall disgorge any remuneration paid to such pharmacy benefit manager or an affiliate of such pharmacy benefit manager in violation of this subparagraph to the PDP sponsor. (vi)Additional requirementsThe pharmacy benefit manager shall— (I)enter into a written agreement with any affiliate of such pharmacy benefit manager, under which the affiliate shall identify and disgorge any remuneration described in clause (v) to the pharmacy benefit manager; and (II)attest, subject to any requirements determined appropriate by the Secretary, that the pharmacy benefit manager has entered into a written agreement described in subclause (I) with any relevant affiliate of the pharmacy benefit manager. (B)Transparency regarding guarantees and cost performance evaluationsThe pharmacy benefit manager shall— (i)define, interpret, and apply, in a fully transparent and consistent manner for purposes of calculating or otherwise evaluating pharmacy benefit manager performance against pricing guarantees or similar cost performance measurements related to rebates, discounts, price concessions, or net costs, terms such as— (I)generic drug, in a manner consistent with the definition of the term under section 423.4 of title 42, Code of Federal Regulations, or a successor regulation; (II)brand name drug, in a manner consistent with the definition of the term under section 423.4 of title 42, Code of Federal Regulations, or a successor regulation; (III)specialty drug; (IV)rebate; and (V)discount; (ii)identify any drugs, claims, or price concessions excluded from any pricing guarantee or other cost performance measure in a clear and consistent manner; and (iii)where a pricing guarantee or other cost performance measure is based on a pricing benchmark other than the wholesale acquisition cost (as defined in section 1847A(c)(6)(B)) of a drug, calculate and provide a wholesale acquisition cost-based equivalent to the pricing guarantee or other cost performance measure. (C)Provision of information (i)In generalNot later than July 1 of each year, beginning in 2029, the pharmacy benefit manager shall submit to the PDP sponsor, and to the Secretary, a report, in accordance with this subparagraph, and shall make such report available to such sponsor at no cost to such sponsor in a format specified by the Secretary under paragraph (5). Each such report shall include, with respect to such PDP sponsor and each plan offered by such sponsor, the following information with respect to the previous plan year: (I)A list of all drugs covered by the plan that were dispensed including, with respect to each such drug— (aa)the brand name, generic or non-proprietary name, and National Drug Code; (bb)the number of plan enrollees for whom the drug was dispensed, the total number of prescription claims for the drug (including original prescriptions and refills, counted as separate claims), and the total number of dosage units of the drug dispensed; (cc)the number of prescription claims described in item (bb) by each type of dispensing channel through which the drug was dispensed, including retail, mail order, specialty pharmacy, long term care pharmacy, home infusion pharmacy, or other types of pharmacies or providers; (dd)the average wholesale acquisition cost, listed as cost per day’s supply, cost per dosage unit, and cost per typical course of treatment (as applicable); (ee)the average wholesale price for the drug, listed as price per day’s supply, price per dosage unit, and price per typical course of treatment (as applicable); (ff)the total out-of-pocket spending by plan enrollees on such drug after application of any benefits under the plan, including plan enrollee spending through copayments, coinsurance, and deductibles; (gg)total rebates paid by the manufacturer on the drug as reported under the Detailed DIR Report (or any successor report) submitted by such sponsor to the Centers for Medicare & Medicaid Services; (hh)all other direct or indirect remuneration on the drug as reported under the Detailed DIR Report (or any successor report) submitted by such sponsor to the Centers for Medicare & Medicaid Services; (ii)the average pharmacy reimbursement amount paid by the plan for the drug in the aggregate and disaggregated by dispensing channel identified in item (cc); (jj)the average National Average Drug Acquisition Cost (NADAC); and (kk)total manufacturer-derived revenue, inclusive of bona fide service fees, attributable to the drug and retained by the pharmacy benefit manager and any affiliate of such pharmacy benefit manager. (II)In the case of a pharmacy benefit manager that has an affiliate that is a retail, mail order, or specialty pharmacy, with respect to drugs covered by such plan that were dispensed, the following information: (aa)The percentage of total prescriptions that were dispensed by pharmacies that are an affiliate of the pharmacy benefit manager for each drug. (bb)The interquartile range of the total combined costs paid by the plan and plan enrollees, per dosage unit, per course of treatment, per 30-day supply, and per 90-day supply for each drug dispensed by pharmacies that are not an affiliate of the pharmacy benefit manager and that are included in the pharmacy network of such plan. (cc)The interquartile range of the total combined costs paid by the plan and plan enrollees, per dosage unit, per course of treatment, per 30-day supply, and per 90-day supply for each drug dispensed by pharmacies that are an affiliate of the pharmacy benefit manager and that are included in the pharmacy network of such plan. (dd)The lowest total combined cost paid by the plan and plan enrollees, per dosage unit, per course of treatment, per 30-day supply, and per 90-day supply, for each drug that is available from any pharmacy included in the pharmacy network of such plan. (ee)The difference between the average acquisition cost of the affiliate, such as a pharmacy or other entity that acquires prescription drugs, that initially acquires the drug and the amount reported under subclause (I)(jj) for each drug. (ff)A list inclusive of the brand name, generic or non-proprietary name, and National Drug Code of covered part D drugs subject to an agreement with a covered entity under section 340B of the Public Health Service Act for which the pharmacy benefit manager or an affiliate of the pharmacy benefit manager had a contract or other arrangement with such a covered entity in the service area of such plan. (III)Where a drug approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act (referred to in this subclause as the listed drug) is covered by the plan, the following information: (aa)A list of currently marketed generic drugs approved under section 505(j) of the Federal Food, Drug, and Cosmetic Act pursuant to an application that references such listed drug that are not covered by the plan, are covered on the same formulary tier or a formulary tier typically associated with higher cost-sharing than the listed drug, or are subject to utilization management that the listed drug is not subject to. (bb)The estimated average beneficiary cost-sharing under the plan for a 30-day supply of the listed drug. (cc)Where a generic drug listed under item (aa) is on a formulary tier typically associated with higher cost-sharing than the listed drug, the estimated average cost-sharing that a beneficiary would have paid for a 30-day supply of each of the generic drugs described in item (aa), had the plan provided coverage for such drugs on the same formulary tier as the listed drug. (dd)A written justification for providing more favorable coverage of the listed drug than the generic drugs described in item (aa). (ee)The number of currently marketed generic drugs approved under section 505(j) of the Federal Food, Drug, and Cosmetic Act pursuant to an application that references such listed drug. (IV)Where a reference product (as defined in section 351(i) of the Public Health Service Act) is covered by the plan, the following information: (aa)A list of currently marketed biosimilar biological products licensed under section 351(k) of the Public Health Service Act pursuant to an application that refers to such reference product that are not covered by the plan, are covered on the same formulary tier or a formulary tier typically associated with higher cost-sharing than the reference product, or are subject to utilization management that the reference product is not subject to. (bb)The estimated average beneficiary cost-sharing under the plan for a 30-day supply of the reference product. (cc)Where a biosimilar biological product listed under item (aa) is on a formulary tier typically associated with higher cost-sharing than the reference product, the estimated average cost-sharing that a beneficiary would have paid for a 30-day supply of each of the biosimilar biological products described in item (aa), had the plan provided coverage for such products on the same formulary tier as the reference product. (dd)A written justification for providing more favorable coverage of the reference product than the biosimilar biological product described in item (aa). (ee)The number of currently marketed biosimilar biological products licensed under section 351(k) of the Public Health Service Act, pursuant to an application that refers to such reference product. (V)Total gross spending on covered part D drugs by the plan, not net of rebates, fees, discounts, or other direct or indirect remuneration. (VI)The total amount retained by the pharmacy benefit manager or an affiliate of such pharmacy benefit manager in revenue related to utilization of covered part D drugs under that plan, inclusive of bona fide service fees. (VII)The total spending on covered part D drugs net of rebates, fees, discounts, or other direct and indirect remuneration by the plan. (VIII)An explanation of any benefit design parameters under such plan that encourage plan enrollees to fill prescriptions at pharmacies that are an affiliate of such pharmacy benefit manager, such as mail and specialty home delivery programs, and retail and mail auto-refill programs. (IX)The following information: (aa)A list of all brokers, consultants, advisors, and auditors that receive compensation from the pharmacy benefit manager or an affiliate of such pharmacy benefit manager for referrals, consulting, auditing, or other services offered to PDP sponsors related to pharmacy benefit management services. (bb)The amount of compensation provided by such pharmacy benefit manager or affiliate to each such broker, consultant, advisor, and auditor. (cc)The methodology for calculating the amount of compensation provided by such pharmacy benefit manager or affiliate, for each such broker, consultant, advisor, and auditor. (X)A list of all affiliates of the pharmacy benefit manager. (XI)A summary document submitted in a standardized template developed by the Secretary that includes such information described in subclauses (I) through (X). (ii)Written explanation of contracts or agreements with drug manufacturers (I)In generalThe pharmacy benefit manager shall, not later than 30 days after the finalization of any contract or agreement between such pharmacy benefit manager or an affiliate of such pharmacy benefit manager and a drug manufacturer (or subsidiary, agent, or entity affiliated with such drug manufacturer) that makes rebates, discounts, payments, or other financial incentives related to one or more covered part D drugs or other prescription drugs, as applicable, of the manufacturer directly or indirectly contingent upon coverage, formulary placement, or utilization management conditions on any other covered part D drugs or other prescription drugs, as applicable, submit to the PDP sponsor a written explanation of such contract or agreement. (II)RequirementsA written explanation under subclause (I) shall— (aa)include the manufacturer subject to the contract or agreement, all covered part D drugs and other prescription drugs, as applicable, subject to the contract or agreement and the manufacturers of such drugs, and a high-level description of the terms of such contract or agreement and how such terms apply to such drugs; and (bb)be certified by the Chief Executive Officer, Chief Financial Officer, or General Counsel of such pharmacy benefit manager, or affiliate of such pharmacy benefit manager, as applicable, or an individual delegated with the authority to sign on behalf of one of these officers, who reports directly to the officer. (III)Definition of other prescription drugsFor purposes of this clause, the term other prescription drugs means prescription drugs covered as supplemental benefits under this part or prescription drugs paid outside of this part. (D)Audit rights (i)In generalNot less than once a year, at the request of the PDP sponsor, the pharmacy benefit manager shall allow for an audit of the pharmacy benefit manager to ensure compliance with all terms and conditions under the written agreement described in this paragraph and the accuracy of information reported under subparagraph (C). (ii)AuditorThe PDP sponsor shall have the right to select an auditor. The pharmacy benefit manager shall not impose any limitations on the selection of such auditor. (iii)Provision of informationThe pharmacy benefit manager shall make available to such auditor all records, data, contracts, and other information necessary to confirm the accuracy of information provided under subparagraph (C), subject to reasonable restrictions on how such information must be reported to prevent redisclosure of such information. (iv)TimingThe pharmacy benefit manager must provide information under clause (iii) and other information, data, and records relevant to the audit to such auditor within 6 months of the initiation of the audit and respond to requests for additional information from such auditor within 30 days after the request for additional information. (v)Information from affiliatesThe pharmacy benefit manager shall be responsible for providing to such auditor information required to be reported under subparagraph (C) or under clause (iii) of this subparagraph that is owned or held by an affiliate of such pharmacy benefit manager. (2)Enforcement (A)In generalEach PDP sponsor shall— (i)disgorge to the Secretary any amounts disgorged to the PDP sponsor by a pharmacy benefit manager under paragraph (1)(A)(v); (ii)require, in a written agreement with any pharmacy benefit manager acting on behalf of such sponsor or affiliate of such pharmacy benefit manager, that such pharmacy benefit manager or affiliate reimburse the PDP sponsor for any civil money penalty imposed on the PDP sponsor as a result of the failure of the pharmacy benefit manager or affiliate to meet the requirements of paragraph (1) that are applicable to the pharmacy benefit manager or affiliate under the agreement; and (iii)require, in a written agreement with any such pharmacy benefit manager acting on behalf of such sponsor or affiliate of such pharmacy benefit manager, that such pharmacy benefit manager or affiliate be subject to punitive remedies for breach of contract for failure to comply with the requirements applicable under paragraph (1). (B)Reporting of alleged violationsThe Secretary shall make available and maintain a mechanism for manufacturers, PDP sponsors, pharmacies, and other entities that have contractual relationships with pharmacy benefit managers or affiliates of such pharmacy benefit managers to report, on a confidential basis, alleged violations of paragraph (1)(A) or subparagraph (C). (C)Anti-retaliation and anti-coercionConsistent with applicable Federal or State law, a PDP sponsor shall not— (i)retaliate against an individual or entity for reporting an alleged violation under subparagraph (B); or (ii)coerce, intimidate, threaten, or interfere with the ability of an individual or entity to report any such alleged violations. (3)Certification of compliance (A)In generalEach PDP sponsor shall furnish to the Secretary (at a time and in a manner specified by the Secretary) an annual certification of compliance with this subsection, as well as such information as the Secretary determines necessary to carry out this subsection. (B)ImplementationNotwithstanding any other provision of law, the Secretary may implement this paragraph by program instruction or otherwise. (4)Rule of constructionNothing in this subsection shall be construed as— (A)prohibiting flat dispensing fees or reimbursement or payment for ingredient costs (including customary, industry-standard discounts directly related to drug acquisition that are retained by pharmacies or wholesalers) to entities that acquire or dispense prescription drugs; or (B)modifying regulatory requirements or sub-regulatory program instruction or guidance related to pharmacy payment, reimbursement, or dispensing fees. (5)Standard formats (A)In generalNot later than June 1, 2028, the Secretary shall specify standard, machine-readable formats for pharmacy benefit managers to submit annual reports required under paragraph (1)(C)(i). (B)ImplementationNotwithstanding any other provision of law, the Secretary may implement this paragraph by program instruction or otherwise. (6)Confidentiality (A)In generalInformation disclosed by a pharmacy benefit manager, an affiliate of a pharmacy benefit manager, a PDP sponsor, or a pharmacy under this subsection that is not otherwise publicly available or available for purchase shall not be disclosed by the Secretary or a PDP sponsor receiving the information, except that the Secretary may disclose the information for the following purposes: (i)As the Secretary determines necessary to carry out this part. (ii)To permit the Comptroller General to review the information provided. (iii)To permit the Director of the Congressional Budget Office to review the information provided. (iv)To permit the Executive Director of the Medicare Payment Advisory Commission to review the information provided. (v)To the Attorney General for the purposes of conducting oversight and enforcement under this title. (vi)To the Inspector General of the Department of Health and Human Services in accordance with its authorities under the Inspector General Act of 1978 (section 406 of title 5, United States Code), and other applicable statutes. (B)Restriction on use of informationThe Secretary, the Comptroller General, the Director of the Congressional Budget Office, and the Executive Director of the Medicare Payment Advisory Commission shall not report on or disclose information disclosed pursuant to subparagraph (A) to the public in a manner that would identify— (i)a specific pharmacy benefit manager, affiliate, pharmacy, manufacturer, wholesaler, PDP sponsor, or plan; or (ii)contract prices, rebates, discounts, or other remuneration for specific drugs in a manner that may allow the identification of specific contracting parties or of such specific drugs. (7)DefinitionsFor purposes of this subsection: (A)AffiliateThe term affiliate means, with respect to any pharmacy benefit manager or PDP sponsor, any entity that, directly or indirectly— (i)owns or is owned by, controls or is controlled by, or is otherwise related in any ownership structure to such pharmacy benefit manager or PDP sponsor; or (ii)acts as a contractor, principal, or agent to such pharmacy benefit manager or PDP sponsor, insofar as such contractor, principal, or agent performs any of the functions described under subparagraph (C). (B)Bona fide service feeThe term bona fide service fee means a fee that is reflective of the fair market value (as specified by the Secretary, through notice and comment rulemaking) for a bona fide, itemized service actually performed on behalf of an entity, that the entity would otherwise perform (or contract for) in the absence of the service arrangement and that is not passed on in whole or in part to a client or customer, whether or not the entity takes title to the drug. Such fee must be a flat dollar amount and shall not be directly or indirectly based on, or contingent upon— (i)drug price, such as wholesale acquisition cost or drug benchmark price (such as average wholesale price); (ii)the amount of discounts, rebates, fees, or other direct or indirect remuneration with respect to covered part D drugs dispensed to enrollees in a prescription drug plan, except as permitted pursuant to paragraph (1)(A)(ii); (iii)coverage or formulary placement decisions or the volume or value of any referrals or business generated between the parties to the arrangement; or (iv)any other amounts or methodologies prohibited by the Secretary. (C)Pharmacy benefit managerThe term pharmacy benefit manager means any person or entity that, either directly or through an intermediary, acts as a price negotiator or group purchaser on behalf of a PDP sponsor or prescription drug plan, or manages the prescription drug benefits provided by such sponsor or plan, including the processing and payment of claims for prescription drugs, the performance of drug utilization review, the processing of drug prior authorization requests, the adjudication of appeals or grievances related to the prescription drug benefit, contracting with network pharmacies, controlling the cost of covered part D drugs, or the provision of related services. Such term includes any person or entity that carries out one or more of the activities described in the preceding sentence, irrespective of whether such person or entity calls itself a pharmacy benefit manager.. (F)Requirements relating to pharmacy benefit managersFor plan years beginning on or after January 1, 2029, section 1860D–12(h)..

6. Expedited consideration of enhanced premium tax credit reform bill Only an enhanced premium tax credit reform bill shall be entitled to expedited consideration under this section. In this section, the term enhanced premium tax credit reform bill means a bill or joint resolution which consists solely of legislative language with respect to continued health insurance premium savings, including more significant reforms, that has accumulated at least 10 cosponsors from each of the majority party and the minority party at the time it is offered. Any committee of the House of Representatives to which an enhanced premium tax credit reform bill is referred shall report the enhanced premium tax credit reform bill to the House of Representatives without amendment not later than 5 legislative days after the date on which the enhanced premium tax credit reform bill was so referred. If a committee of the House of Representatives fails to report an enhanced premium tax credit reform bill within that period, that committee shall be automatically discharged from consideration of the enhanced premium tax credit reform bill, and the enhanced premium tax credit reform bill shall be placed on the appropriate calendar. After the last committee authorized to consider an enhanced premium tax credit reform bill reports it to the House of Representatives or has been discharged from its consideration, it shall be in order to move to proceed to consider the enhanced premium tax credit reform bill in the House of Representatives. Such a motion shall not be in order after the House of Representatives has disposed of a motion to proceed with respect to the enhanced premium tax credit reform bill. The previous question shall be considered as ordered on the motion to its adoption without intervening motion. The motion shall not be debatable. A motion to reconsider the vote by which the motion is disposed of shall not be in order. The vote on passage of the enhanced premium tax credit reform bill shall occur not later than 3 legislative days after the date on which the last committee authorized to consider the enhanced premium tax credit reform bill reports it to the House of Representatives or is discharged. An enhanced premium tax credit reform bill introduced in the Senate shall be jointly referred to the committee or committees of jurisdiction, which committees shall report the enhanced premium tax credit reform bill without any revision and with a favorable recommendation, an unfavorable recommendation, or without recommendation, not later than 5 session days after the date on which the enhanced premium tax credit reform bill was so referred. If any committee to which an enhanced premium tax credit reform bill is referred fails to report the enhanced premium tax credit reform bill within that period, that committee shall be automatically discharged from consideration of the enhanced premium tax credit reform bill, and the enhanced premium tax credit reform bill shall be placed on the appropriate calendar. Notwithstanding rule XXII of the Standing Rules of the Senate, it is in order, not later than 2 days of session after the date on which an enhanced premium tax credit reform bill is reported or discharged from all committees to which the enhanced premium tax credit reform bill was referred, for the majority leader of the Senate or the designee of the majority leader to move to proceed to the consideration of the enhanced premium tax credit reform bill. It shall also be in order for any Member of the Senate to move to proceed to the consideration of the enhanced premium tax credit reform bill at any time after the conclusion of such 2-day period. A motion to proceed is in order even though a previous motion to the same effect has been disagreed to. All points of order against the motion to proceed to the enhanced premium tax credit reform bill are waived. The motion to proceed is not debatable. The motion is not subject to a motion to postpone. A motion to reconsider the vote by which the motion is agreed to or disagreed to shall not be in order. If a motion to proceed to the consideration of the enhanced premium tax credit reform bill is agreed to, the enhanced premium tax credit reform bill shall remain the unfinished business until disposed of. All points of order against an enhanced premium tax credit reform bill and against consideration of the enhanced premium tax credit reform bill are waived. If, before passing an enhanced premium tax credit reform bill, a House receives from the other House an enhanced premium tax credit reform bill of the other House— the enhanced premium tax credit reform bill of the other House shall not be referred to a committee; and the procedure in the receiving House shall be the same as if no enhanced premium tax credit reform bill had been received from the other House until the vote on passage, when the enhanced premium tax credit reform bill received from the other House shall supplant the enhanced premium tax credit reform bill of the receiving House. This subsection shall not apply to the House of Representatives if an enhanced premium tax credit reform bill received from the Senate is a revenue measure. If an enhanced premium tax credit reform bill is not introduced in the Senate or the Senate fails to consider an enhanced premium tax credit reform bill under this section, the enhanced premium tax credit reform bill of the House of Representatives shall be entitled to expedited floor procedures under this section. If, following passage of an enhanced premium tax credit reform bill in the Senate, the Senate then receives from the House of Representatives an enhanced premium tax credit reform bill, the House-passed enhanced premium tax credit reform bill shall not be debatable. The vote on passage of the enhanced premium tax credit reform bill in the Senate shall be considered to be the vote on passage of the enhanced premium tax credit reform bill received from the House of Representatives. If the President vetoes an enhanced premium tax credit reform bill, consideration of a veto message in the Senate under this paragraph shall be 10 hours equally divided between the majority and minority leaders of the Senate or the designees of the majority and minority leaders of the Senate. The vote on final passage in the House of Representatives and the Senate of the enhanced premium tax credit reform bill shall occur not later than July 1, 2026. This section is enacted by Congress— as an exercise of the rulemaking power of the Senate and House of Representatives, respectively, and as such it is deemed a part of the rules of each House, respectively, but applicable only with respect to the procedure to be followed in that House in the case of an enhanced premium tax credit reform bill, and it supersedes other rules only to the extent that it is inconsistent with such rules; and with full recognition of the constitutional right of either House to change the rules (so far as relating to the procedure of that House) at any time, in the same manner, and to the same extent as in the case of any other rule of that House.