Lower Costs for Everyday Americans Act · Introduced in House (2025-03-03)

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Lower Costs for Everyday Americans Act · Introduced in House (2025-03-03) · Congress.wiki

(1) In this section: (A) The term Administrator means the Administrator of the Environmental Protection Agency. (B) The term compost means a product that— (i) is manufactured through the controlled aerobic, biological decomposition of biodegradable materials; (ii) has been subjected to medium and high temperature organisms, which— (I) significantly reduce the viability of pathogens and weed seeds; and (II) stabilize carbon in the product such that the product is beneficial to plant growth; and (iii) is typically used as a soil amendment, but may also contribute plant nutrients. (C) The term compostable material means material that is a feedstock for creating compost, including— (i) wood; (ii) agricultural crops; (iii) paper, such as cardboard and other paper products; (iv) certified compostable products associated with organic waste; (v) other organic plant material; (vi) organic waste, including food waste and yard waste; and (vii) such other material that is composed of biomass that can be continually replenished or renewed, as determined by the Administrator. (D) The term Indian Tribe has the meaning given the term in section 4 of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 5304). (E) The term recyclable material means a material that is obsolete, previously used, off-specification, surplus, or incidentally produced for processing into a specification-grade commodity for which a reuse market currently exists or is being developed. (F) The term recycling means the series of activities— (i) during which recyclable materials are processed into specification-grade commodities and consumed as raw-material feedstock, in lieu of virgin materials, in the manufacturing of new products; (ii) that may, with regard to recyclable materials and prior to the activities described in clause (i), include sorting, collection, processing, and brokering; and (iii) that result, subsequent to processing described in clause (i), in consumption by a materials manufacturer, including for the manufacturing of new products. (G) The term State has the meaning given the term in section 1004 of the Solid Waste Disposal Act (42 U.S.C. 6903).

SEC. 4011. Reports on composting and recycling infrastructure capabilities (a) Definitions In this section: (1) The terms , , , and have the meanings given the terms in subsection (b) of the . compost,compostable material,recyclable material,recycling

(2) The term composting facility means a location, structure, or device that transforms compostable materials into compost.

(3) The term Indian Tribe has the meaning given the term in section 4 of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 5304).

(4) Materials recovery facility (A) The term materials recovery facility means a dedicated facility where primarily residential recyclable materials, which are diverted from disposal by the generator and collected separately from municipal solid waste, are mechanically or manually sorted into commodities for further processing into specification-grade commodities for sale to end users. (B) The term does not include a solid waste management facility that may process municipal solid waste to remove recyclable materials. materials recovery facility (C) For purposes of this paragraph, the term processing has the meaning given the term in subsection (b)(2) of the . (b) Report (1) The Administrator shall request information and data from, collaborate with, or contract with, as necessary and appropriate, States, units of local government, and Indian Tribes, for the provision, preparation, and publication of a report, or to expand work under the National Recycling Strategy to include information and data, on compostable materials and efforts to reduce contamination rates for recycling, including— (A) an evaluation of existing Federal, State, and local laws that may present barriers to implementation of composting strategies; (B) a description and evaluation of composting infrastructure and programs within States, units of local government, and Indian Tribes; (C) an estimate of the costs and approximate land needed to expand composting programs; and (D) a review of the practices of manufacturers and companies that are moving to using compostable packaging and food service ware for the purpose of making the composting process the end-of-life use of those products.

(2) Not later than 2 years after the date of enactment of this section, the Administrator shall submit to Congress the report prepared under paragraph (1). (c) Inventory of materials recovery facilities Not later than 3 years after the date of enactment of this section, and every 4 years thereafter, the Administrator, in consultation with relevant Federal agencies and States, units of local government, and Indian Tribes, shall— (1) prepare an inventory or estimate of materials recovery facilities in the United States, including— (A) the number of materials recovery facilities in each State; and (B) a general description of the materials that each of those materials recovery facilities can process, including— (i) in the case of plastic, a description of— (I) the types of accepted resin, if applicable; and (II) the packaging or product format, such as a jug, a carton, or film; (ii) food packaging and service ware, such as a bottle, cutlery, or a cup; (iii) paper; (iv) aluminum, such as an aluminum beverage can, food can, aerosol can, or foil; (v) steel, such as a steel food or aerosol can; (vi) other scrap metal; (vii) glass; or (viii) any other material not described in any of clauses (i) through (vii) that a materials recovery facility processes; and

(2) submit to Congress the inventory or estimate prepared under paragraph (1). (d) Information on recycling and composting systems The Administrator shall, as necessary and appropriate, collaborate or contract with States, units of local government, and Indian Tribes to estimate, with respect to the United States— (1) the number and types of recycling and composting programs;

(2) the types and forms of materials accepted by recycling or composting programs;

(3) the number of individuals— (A) with access to recycling and composting services to at least the extent of access to disposal services; and (B) who use, on a percentage basis, the recycling and composting services described in subparagraph (A);

(4) the number of individuals with barriers to accessing recycling and composting services similar to their access to disposal services and the types of those barriers experienced;

(5) the inbound contamination and capture rates of recycling and composting programs;

(6) if applicable, other available recycling or composting programs; and

(7) the average costs and benefits to States, units of local government, and Indian Tribes of recycling and composting programs. (e) Recycling reporting rates (1) The Administrator may use amounts made available under subsection (f) of the — (A) to biannually collect, in collaboration with States, to the extent practicable, information supplied on a voluntary basis to develop the estimated rates described in subparagraphs (B) and (C); (B) to develop a standardized estimated rate of recyclable materials in States that provide information under subparagraph (A) that have been successfully diverted from the waste stream and brought to a materials recovery facility or composting facility; and (C) to develop an estimated national recycling rate based on the information described in subparagraphs (A) and (B).

(2) Using amounts made available under subsection (f) of the , the Administrator may use the information collected and rates developed under paragraph (1) to provide requesting States, units of local government, and Indian Tribes data and technical assistance— (A) to reduce the overall waste produced by the States, units of local government, and Indian Tribes; (B) to assist the States, units of local government, and Indian Tribes in understanding the nuances of the information collected relating to diversion activities; and (C) to increase recycling and composting rates of the States, units of local government, and Indian Tribes. (f) Report on end markets The Administrator, in collaboration or contract with, as necessary and appropriate, relevant Federal agencies, States, units of local government, or Indian Tribes, shall— (1) provide an update to the report submitted under section 306 of the Save Our Seas 2.0 Act (; 134 Stat. 1096) to include an addendum on the end-market sale of all recyclable materials from materials recovery facilities that process recyclable materials, including, to the extent practicable— (Public Law 116–224) (A) the total, in dollars per ton, domestic sales of bales of recyclable materials; and (B) the total, in dollars per ton, international sales of bales of recyclable materials;

(2) prepare a report on the end-market sale of compost from, to the extent practicable, compostable materials, including the total, in dollars per ton, of domestic sales of compostable materials; and

(3) not later than 3 years after the date of enactment of this section, submit to Congress the update to the report prepared under paragraph (1) and the report prepared under paragraph (2). (g) Privileged or confidential information (1) Information collected under subsection (e)(1) or paragraph (1) or (2) of subsection (f) shall not include any privileged or confidential information described in section 552(b)(4) of title 5, United States Code.

(2) Information collected to carry out this section shall not be made public if the information meets the requirements of section 552(b) of title 5, United States Code..

Not later than 1 year after the date of the enactment of this Act, the Assistant Secretary shall carry out the following activities: (1) In consultation with the Working Group— (A) assessing, mapping, and modeling critical supply chains, including for critical and emerging technologies, which may include— (i) modeling the impact of supply chain shocks on critical industries (including for critical and emerging technologies), and critical supply chains; (ii) assessing the demand for and supply of critical goods, production equipment, and manufacturing technology needed for critical supply chains, including critical goods, production equipment, and manufacturing technology obtained by or purchased from a person outside of the United States or imported into the United States; and (iii) assessing manufacturing, warehousing, transportation, and distribution related to critical supply chains; (B) identifying high priority gaps and vulnerabilities in critical supply chains and critical industries (including critical industries for critical and emerging technologies) that— (i) exist as of the date of the enactment of this Act; or (ii) are anticipated to occur after the date of the enactment of this Act; (C) identifying potential supply chain shocks to a critical supply chain that may disrupt, strain, or eliminate the critical supply chain; (D) evaluating the capability and capacity of domestic manufacturers or manufacturers located in countries that are allies or key international partner nations to serve as sources for critical goods, production equipment, or manufacturing technology needed in critical supply chains; (E) evaluating the effect on market stability that may result from the disruption, strain, or elimination of a critical supply chain; (F) evaluating the state of the manufacturing workforce, including by— (i) identifying the needs of domestic manufacturers; and (ii) identifying opportunities to create high-quality manufacturing jobs; and (G) identifying and describing necessary tools, including commercially available risk assessment tools, that leverage data and industry expertise to provide insights into critical supply chain vulnerabilities, including how such tools fulfill the requirements described in subparagraphs (A) through (F).

(1) Not later than 18 months after the date of the enactment of this Act, and annually thereafter, the Assistant Secretary, in consultation with the Working Group, covered nongovernmental representatives, industries, institutions of higher education, and State and local governments, shall submit to the relevant committees of Congress a report that— (A) identifies— (i) critical infrastructure that may assist in fulfilling the responsibilities described in section 402; (ii) critical and emerging technologies that may assist in fulfilling the responsibilities described in section 402, including such technologies that may be critical to addressing preparedness, weaknesses, and vulnerabilities relating to critical supply chains; (iii) critical industries, critical supply chains, and critical goods designated pursuant to subsection (d); (iv) other supplies and services that are critical to the crisis preparedness of the United States; (v) substitutes for critical goods, production equipment, and manufacturing technology; (vi) methods and technologies, including blockchain technology, distributed ledger technology, and other critical and emerging technologies, as appropriate, for the authentication and traceability of critical goods; and (vii) countries that are allies or key international partner nations; (B) describes the matters identified and evaluated under subsection (b)(1), including— (i) the manufacturing base, critical supply chains, and emerging technologies in the United States, including the manufacturing base and critical supply chains for— (I) critical goods; (II) production equipment; and (III) manufacturing technology; and (ii) the ability of the United States to— (I) maintain readiness with respect to preparing for and responding to supply chain shocks; and (II) in response to a supply chain shock— (C) assesses and describes— (i) the demand and supply of critical goods, production equipment, and manufacturing technology; (ii) the production of critical goods, production equipment, and manufacturing technology by domestic manufacturers; (iii) the capability and capacity of domestic manufacturers and manufacturers in countries that are allies or key international partner nations to manufacture critical goods, production equipment, and manufacturing technology; and (iv) how supply chain shocks could affect rural, Tribal, and underserved communities; (D) identifies threats and supply chain shocks that may disrupt, strain, or eliminate critical supply chains, critical goods, and critical industries (including critical industries for emerging technologies); (E) with regard to any threat identified under subparagraph (D), lists any threat or supply chain shock that may originate from a country, or a company or individual from a country, that is described in section 407(2)(B); (F) assesses— (i) the resilience and capacity of the manufacturing base, critical supply chains, and workforce of the United States and countries that are allies or key international partner nations that can sustain critical industries (including critical industries for emerging technologies) through a supply chain shock; and (ii) the effect innovation has on domestic manufacturers; (G) assesses the flexible manufacturing capacity and capability available in the United States in the case of a supply chain shock; and (H) develops a strategy for the Department of Commerce to support the resilience, diversity, and strength of critical supply chains and critical and emerging technologies to— (i) support sufficient access to critical goods by mitigating vulnerabilities in critical supply chains, including critical supply chains concentrated in countries that are described in section 407(2)(B); (ii) consult with other relevant agencies to assist countries that are allies or key international partner nations in building capacity for manufacturing critical goods; (iii) recover from supply chain shocks; (iv) identify, in consultation with the Working Group and other relevant agencies, actions relating to critical supply chains or emerging technologies that the United States may take to improve responses to supply chain shocks; (v) protect against supply chain shocks relating to critical supply chains from countries that are described in section 407(2)(B); and (vi) make specific recommendations to implement the strategy under this section and improve the security and resiliency of manufacturing capacity and supply chains for critical industries (including critical industries for emerging technologies) by— (I) developing long-term strategies; (II) increasing visibility into the networks and capabilities of domestic manufacturers and suppliers of domestic manufacturers; (III) identifying and mitigating risks, including— (IV) identifying opportunities to reuse and recycle critical goods, including raw materials, to increase resilient critical supply chains; (V) consulting with countries that are allies or key international partner nations on— (VI) providing guidance to other relevant agencies with respect to critical goods, supply chains, and critical industries (including critical industries for emerging technologies) that should be prioritized to support United States leadership in the deployment of such technologies.

(1) Protection (A) Notwithstanding any other provision of law, critical supply chain information (including the identity of the submitting person or entity) that is voluntarily submitted under this section to the Department of Commerce for use by the Department for purposes of this section, when accompanied by an express statement described in subparagraph (B)— (i) shall be exempt from disclosure under section 552(b)(3) of title 5, United States Code (commonly referred to as the ); "Freedom of Information Act" (ii) is not subject to any agency rules or judicial doctrine regarding ex parte communications with a decision-making official; (iii) may not, without the written consent of the person or entity submitting such information, be used directly by the Department of Commerce, any other Federal, State, or local authority, or any third party, in any civil action arising under Federal or State law if such information is submitted in good faith; (iv) may not, without the written consent of the person or entity submitting such information, be used or disclosed by any officer or employee of the United States for purposes other than the purposes of this section, except— (I) in furtherance of an investigation or the prosecution of a criminal act; or (II) when disclosure of the information would be— (v) may not, if provided to a State or local government or government agency— (I) be made available pursuant to any State or local law requiring disclosure of information or records; (II) otherwise be disclosed or distributed to any party by such State or local government or government agency without the written consent of the person or entity submitting such information; or (III) be used other than for the purpose of carrying out this section, or in furtherance of an investigation or the prosecution of a criminal act; and (vi) does not constitute a waiver of any applicable privilege or protection provided under law, such as trade secret protection. (B) The express statement described in this subparagraph, with respect to information or records, is— (i) in the case of written information or records, a written marking on the information or records substantially similar to the following: ; or "This information is voluntarily submitted to the Federal Government in expectation of protection from disclosure as provided by the provisions of the Promoting Resilient Supply Chains Act." (ii) in the case of oral information, a written statement similar to the statement described in clause (i) submitted within a reasonable period following the oral communication.

(h) Intentional disclosure of nonconsensual intimate visual depictions (1) In this subsection: (A) The term consent means an affirmative, conscious, and voluntary authorization made by an individual free from force, fraud, duress, misrepresentation, or coercion. (B) The term digital forgery means any intimate visual depiction of an identifiable individual created through the use of software, machine learning, artificial intelligence, or any other computer-generated or technological means, including by adapting, modifying, manipulating, or altering an authentic visual depiction, that, when viewed as a whole by a reasonable person, is indistinguishable from an authentic visual depiction of the individual. (C) The term identifiable individual means an individual— (i) who appears in whole or in part in an intimate visual depiction; and (ii) whose face, likeness, or other distinguishing characteristic (including a unique birthmark or other recognizable feature) is displayed in connection with such intimate visual depiction. (D) The term interactive computer service has the meaning given the term in section 230. (E) The term intimate visual depiction has the meaning given such term in section 1309 of the Consolidated Appropriations Act, 2022 (15 U.S.C. 6851). (F) The term minor means any individual under the age of 18 years.

(2) Offense involving authentic intimate visual depictions (A) Except as provided in subparagraph (C), it shall be unlawful for any person, in interstate or foreign commerce, to use an interactive computer service to knowingly publish an intimate visual depiction of an identifiable individual who is not a minor if— (i) the intimate visual depiction was obtained or created under circumstances in which the person knew or reasonably should have known the identifiable individual had a reasonable expectation of privacy; (ii) what is depicted was not voluntarily exposed by the identifiable individual in a public or commercial setting; (iii) what is depicted is not a matter of public concern; and (iv) publication of the intimate visual depiction— (I) is intended to cause harm; or (II) causes harm, including psychological, financial, or reputational harm, to the identifiable individual. (B) Except as provided in subparagraph (C), it shall be unlawful for any person, in interstate or foreign commerce, to use an interactive computer service to knowingly publish an intimate visual depiction of an identifiable individual who is a minor with intent to— (i) abuse, humiliate, harass, or degrade the minor; or (ii) arouse or gratify the sexual desire of any person. (C) Subparagraphs (A) and (B) shall not apply to— (i) a lawfully authorized investigative, protective, or intelligence activity of— (I) a law enforcement agency of the United States, a State, or a political subdivision of a State; or (II) an intelligence agency of the United States; (ii) a disclosure made reasonably and in good faith— (I) to a law enforcement officer or agency; (II) as part of a document production or filing associated with a legal proceeding; (III) as part of medical education, diagnosis, or treatment or for a legitimate medical, scientific, or education purpose; (IV) in the reporting of unlawful content or unsolicited or unwelcome conduct or in pursuance of a legal, professional, or other lawful obligation; or (V) to seek support or help with respect to the receipt of an unsolicited intimate visual depiction; (iii) a disclosure reasonably intended to assist the identifiable individual; or (iv) a person who possesses or publishes an intimate visual depiction of himself or herself engaged in nudity or sexually explicit conduct (as that term is defined in section 2256(2)(A) of title 18, United States Code).

(3) Offense involving digital forgeries (A) Except as provided in subparagraph (C), it shall be unlawful for any person, in interstate or foreign commerce, to use an interactive computer service to knowingly publish a digital forgery of an identifiable individual who is not a minor if— (i) the digital forgery was published without the consent of the identifiable individual; (ii) what is depicted was not voluntarily exposed by the identifiable individual in a public or commercial setting; (iii) what is depicted is not a matter of public concern; and (iv) publication of the digital forgery— (I) is intended to cause harm; or (II) causes harm, including psychological, financial, or reputational harm, to the identifiable individual. (B) Except as provided in subparagraph (C), it shall be unlawful for any person, in interstate or foreign commerce, to use an interactive computer service to knowingly publish a digital forgery of an identifiable individual who is a minor with intent to— (i) abuse, humiliate, harass, or degrade the minor; or (ii) arouse or gratify the sexual desire of any person. (C) Subparagraphs (A) and (B) shall not apply to— (i) a lawfully authorized investigative, protective, or intelligence activity of— (I) a law enforcement agency of the United States, a State, or a political subdivision of a State; or (II) an intelligence agency of the United States; (ii) a disclosure made reasonably and in good faith— (I) to a law enforcement officer or agency; (II) as part of a document production or filing associated with a legal proceeding; (III) as part of medical education, diagnosis, or treatment or for a legitimate medical, scientific, or education purpose; (IV) in the reporting of unlawful content or unsolicited or unwelcome conduct or in pursuance of a legal, professional, or other lawful obligation; or (V) to seek support or help with respect to the receipt of an unsolicited intimate visual depiction; (iii) a disclosure reasonably intended to assist the identifiable individual; or (iv) a person who possesses or publishes a digital forgery of himself or herself engaged in nudity or sexually explicit conduct (as that term is defined in section 2256(2)(A) of title 18, United States Code).

(4) Penalties (A) Any person who violates paragraph (2)(A) or (3)(A) shall be fined under title 18, United States Code, imprisoned not more than 2 years, or both. (B) Any person who violates paragraph (2)(B) or (3)(B) shall be fined under title 18, United States Code, imprisoned not more than 3 years, or both.

(5) For purposes of paragraphs (2) and (3)— (A) the fact that the identifiable individual provided consent for the creation of the intimate visual depiction shall not establish that the individual provided consent for the publication of the intimate visual depiction; and (B) the fact that the identifiable individual disclosed the intimate visual depiction to another individual shall not establish that the identifiable individual provided consent for the publication of the intimate visual depiction by the person alleged to have violated paragraph (2) or (3), respectively.

(6) Threats (A) Any person who intentionally threatens to commit an offense under paragraph (2) for the purpose of intimidation, coercion, extortion, or to create mental distress shall be punished as provided in paragraph (4). (B) Threats involving digital forgeries (i) Any person who intentionally threatens to commit an offense under paragraph (3)(A) for the purpose of intimidation, coercion, extortion, or to create mental distress shall be fined under title 18, United States Code, imprisoned not more than 18 months, or both. (ii) Any person who intentionally threatens to commit an offense under paragraph (3)(B) for the purpose of intimidation, coercion, extortion, or to create mental distress shall be fined under title 18, United States Code, imprisoned not more than 30 months, or both.

(7) Forfeiture (A) The court, in imposing a sentence on any person convicted of a violation of paragraph (2) or (3), shall order, in addition to any other sentence imposed and irrespective of any provision of State law, that the person forfeit to the United States— (i) any material distributed in violation of that paragraph; (ii) the person’s interest in property, real or personal, constituting or derived from any gross proceeds of the violation, or any property traceable to such property, obtained or retained directly or indirectly as a result of the violation; and (iii) any personal property of the person used, or intended to be used, in any manner or part, to commit or to facilitate the commission of the violation. (B) Section 413 of the Controlled Substances Act (21 U.S.C. 853), with the exception of subsections (a) and (d), shall apply to the criminal forfeiture of property under subparagraph (A).

(8) The court shall order restitution for an offense under paragraph (2) or (3) in the same manner as under section 2264 of title 18, United States Code.

(9) Nothing in this subsection shall be construed to limit the application of any other relevant law, including section 2252 of title 18, United States Code..

(m) Vetting of High-Cost fund recipients (1) In this subsection— (A) the term covered funding means any new offer of high-cost universal service program funding, including funding provided through a reverse competitive bidding mechanism provided under this section, for the deployment of a broadband-capable network and the provision of supported services over the network; and (B) the term new covered funding award means an award of covered funding that is made based on an application submitted to the Commission on or after the date on which rules are promulgated under paragraph (2).

(2) Not later than 180 days after the date of enactment of this subsection, the Commission shall initiate a rulemaking proceeding to establish a vetting process for applicants for, and other recipients of, a new covered funding award.

(3) Contents (A) In promulgating rules under paragraph (2), the Commission shall provide that, consistent with principles of technology neutrality, the Commission will only award covered funding to applicants that can demonstrate that they meet the qualifications in subparagraph (B). (B) An applicant for a new covered funding award shall include in the initial application a proposal containing sufficient detail and documentation for the Commission to ascertain that the applicant possesses the technical, financial, and operational capabilities, and has a reasonable business plan, to deploy the proposed network and deliver services with the relevant performance characteristics and requirements defined by the Commission and as pledged by the applicant. (C) The Commission shall evaluate a proposal described in subparagraph (B) against— (i) reasonable and well-established technical, financial, and operational standards, including the technical standards adopted by the Commission in orders of the Commission relating to Establishing the Digital Opportunity Data Collection (WC Docket No. 19–195) (or orders of the Commission relating to modernizing any successor collection) for purposes of entities that must report broadband availability coverage; and (ii) the applicant’s history of complying with requirements in Commission and other government broadband deployment funding programs. (D) In adopting rules for any new covered funding award, the Commission shall set a penalty for pre-authorization defaults of at least $9,000 per violation and may not limit the base forfeiture to an amount less than 30 percent of the applicant’s total support, unless the Commission demonstrates the need for lower penalties in a particular instance..

(2) Enforcement by states (A) If the attorney general of a State has reason to believe that an interest of the residents of the State has been or is being threatened or adversely affected by a practice that violates subsection (a), the attorney general of the State may, as parens patriae, bring a civil action on behalf of the residents of the State in an appropriate district court of the United States to obtain appropriate relief. (B) Rights of the Commission (i) Notice to the Commission (I) Except as provided in subclause (III), the attorney general of a State, before initiating a civil action under subparagraph (A) shall notify the Commission in writing that the attorney general intends to bring such civil action. (II) The notification required by subclause (I) shall include a copy of the complaint to be filed to initiate the civil action. (III) If it is not feasible for the attorney general of a State to provide the notification required by subclause (I) before initiating a civil action under subparagraph (A), the attorney general shall notify the Commission immediately upon instituting the civil action. (ii) The Commission may— (I) intervene in any civil action brought by the attorney general of a State under subparagraph (A); and (II) upon intervening— (C) Nothing in this paragraph may be construed to prevent the attorney general of a State from exercising the powers conferred on the attorney general by the laws of the State to conduct investigations, to administer oaths or affirmations, or to compel the attendance of witnesses or the production of documentary or other evidence. (D) Whenever a civil action has been instituted by or on behalf of the Commission for violation of subsection (a), no attorney general of a State may, during the pendency of that action, institute an action under subparagraph (A) against any defendant named in the complaint in that action for a violation of subsection (a) alleged in such complaint. (E) Venue; service of process (i) Any action brought under subparagraph (A) may be brought in— (I) the district court of the United States that meets applicable requirements relating to venue under section 1391 of title 28, United States Code; or (II) another court of competent jurisdiction. (ii) In an action brought under subparagraph (A), process may be served in any district in which— (I) the defendant is an inhabitant, may be found, or transacts business; or (II) venue is proper under section 1391 of title 28, United States Code. (F) Actions by other state officials (i) In addition to civil actions brought by an attorney general under subparagraph (A), any other officer of a State who is authorized by the State to do so may bring a civil action under subparagraph (A), subject to the same requirements and limitations that apply under this paragraph to civil actions brought by attorneys general. (ii) Nothing in this paragraph may be construed to prohibit an authorized official of a State from initiating or continuing any proceeding in a court of the State for a violation of any civil or criminal law of the State.

SEC. 106. Office of Spectrum Management (a) Establishment There is established within the NTIA an Office of Spectrum Management (in this section referred to as the ). "Office" (b) Head of office (1) The head of the Office shall be an Associate Administrator for Spectrum Management (in this section referred to as the ). "Associate Administrator"

(2) The Associate Administrator shall report to the Under Secretary (or a designee of the Under Secretary). (c) Duties The Associate Administrator shall, at the direction of the Under Secretary— (1) carry out responsibilities under section 103(b)(2)(A) (relating to frequency assignments for radio stations belonging to and operated by the United States), make frequency allocations for frequencies that will be used by such stations, and develop and maintain techniques, databases, measurements, files, and procedures necessary for such allocations;

(2) carry out responsibilities under section 103(b)(2)(K) (relating to establishing policies concerning spectrum assignments and use by radio stations belonging to and operated by the United States) and provide Federal agencies with guidance to ensure that the conduct of telecommunications activities by such agencies is consistent with such policies;

(3) represent the interests of Federal agencies in the process through which the Commission and the NTIA jointly determine the National Table of Frequency Allocations, and coordinate with the Commission in the development of a comprehensive long-range plan for improved management of all electromagnetic spectrum resources;

(4) appoint the chairpersons of and provide secretariat functions for the Interdepartmental Radio Advisory Committee and the Interagency Spectrum Advisory Council;

(5) carry out responsibilities under section 103(b)(2)(B) (relating to authorizing a foreign government to construct and operate a radio station at the seat of Government of the United States) and assign frequencies for use by such stations;

(6) provide advice and assistance to the Under Secretary and coordinate with the Associate Administrator for International Affairs in carrying out spectrum management aspects of the international policy responsibilities of the NTIA, including spectrum-related responsibilities under section 103(b)(2)(G);

(7) carry out spectrum-related responsibilities under section 103(b)(2)(H) (relating to coordination of the telecommunications activities of the executive branch and assistance in the formulation of policies and standards for such activities);

(8) carry out spectrum-related responsibilities under section 103(b)(2)(Q) (relating to certain activities with respect to telecommunications resources); and

(9) carry out any other duties of the NTIA with respect to spectrum policy that the Under Secretary may designate..

SEC. 107. Office of International Affairs (a) Establishment There is established within the NTIA an Office of International Affairs (in this section referred to as the ). "Office" (b) Head of office (1) The head of the Office shall be an Associate Administrator for International Affairs (in this section referred to as the ). "Associate Administrator"

(2) The Associate Administrator shall report to the Under Secretary (or a designee of the Under Secretary). (c) Duties The Associate Administrator shall, at the direction of the Under Secretary— (1) in coordination with the Secretary of State, conduct analysis of, review, and formulate international telecommunications and information policy;

(2) present on international telecommunications and information policy— (A) before the Commission, Congress, and others; and (B) in coordination with the Secretary of State, before international telecommunications bodies, including the International Telecommunication Union;

(3) conduct or obtain analysis on economic and other aspects of international telecommunications and information policy;

(4) formulate, and recommend to the Under Secretary, polices and plans with respect to preparation for and participation in international telecommunications and information policy activities;

(5) in coordination with the Secretary of State, coordinate NTIA and interdepartmental economic, technical, operational, and other preparations related to participation by the United States in international telecommunications and information policy conferences and negotiations;

(6) ensure NTIA representation with respect to international telecommunications and information policy meetings and the activities related to preparation for such meetings;

(7) in coordination with the Secretary of State, coordinate with Federal agencies and private organizations engaged in activities involving international telecommunications and information policy matters and maintain cognizance of the activities of United States signatories with respect to related treaties, agreements, and other instruments;

(8) provide advice and assistance related to international telecommunications and information policy to other Federal agencies charged with responsibility for international negotiations, to strengthen the position and serve the best interests of the United States in the conduct of negotiations with foreign nations;

(9) provide advice and assistance to the Under Secretary with respect to evaluating the international impact of matters pending before the Commission, other Federal agencies, and Congress;

(10) carry out, at the request of the Secretary, the responsibilities of the Secretary under the Communications Satellite Act of 1962 (47 U.S.C. 701 et seq.) and other Federal laws related to international telecommunications and information policy; and

(11) carry out any other duties of the NTIA with respect to international telecommunications and information policy that the Under Secretary may designate..

(12) Demonstration program to expand coverage for home or community-based services (A) In general (i) Not later than 24 months after the date on which the planning grants under subparagraph (B) are awarded, notwithstanding paragraph (1), the Secretary may approve a waiver that is standalone from any other waiver approved under this subsection for not more than 5 States, selected in accordance with clause (ii), to include as medical assistance under the State plan of such State, for the 3-year period beginning on the date of such approval, payment for part or all of the cost of home or community-based services (other than room and board (as described in paragraph (1))) approved by the Secretary which are provided pursuant to a written plan of care to individuals described in subparagraph (C)(iii). (ii) In selecting States for purposes of clause (i), the Secretary shall— (I) only select States that received a planning grant under subparagraph (B); (II) only select States that meet the requirements specified in subparagraph (C) and such other requirements as the Secretary may determine appropriate; (III) select States in a manner that ensures geographic diversity; (IV) give preference to States with a higher percentage (relative to other States that apply to be selected for purposes of clause (i)) of the total State population residing in rural areas (as determined by the Secretary); (V) give preference to States that have demonstrated more progress in rebalancing long-term services and supports systems under this title, as determined based on the relative share of individuals who use home or community-based services (as defined by the Secretary) under this title as a percentage of total individuals who use long-term services and supports (as defined by the Secretary) under this title (in the most recent year for which such data is available); and (VI) give preference to States that pursue a waiver under this paragraph that incorporates the provision of mental health services for adults with serious mental illness, children with serious emotional disturbances, or individuals with substance use disorder. (B) Planning grants (i) In general (I) Not later than 18 months after the date of the enactment of this paragraph, the Secretary shall award planning grants of not more than $5,000,000 each to not more than 10 States for purposes of preparing to submit a request for a waiver under this subsection (including for costs to implement the waiver or other activities to expand the provision of home or community-based services under this section) to provide home or community-based services to individuals described in subparagraph (C)(iii). (II) In awarding planning grants under subclause (I), the Secretary shall use the selection criteria specified in subclauses (III) through (VI) of subparagraph (A)(ii). (ii) A State that is awarded a planning grant under clause (i) shall, in preparing to submit a request for a waiver described in such clause, consult with— (I) individuals in need of (and not receiving) home or community-based services, individuals receiving home or community-based services, and the caregivers of such individuals; (II) providers furnishing home or community-based services; and (III) such other stakeholders, as the Secretary may specify. (C) In addition to the requirements specified under this subsection (except for the requirements described in subparagraphs (C) and (D) of paragraph (2) and any other requirement the Secretary determines to be inapplicable in the context of a waiver relation to individuals who do not require the level of care described in paragraph (1)), the requirements specified in this paragraph are, with respect to a State, the following: (i) As of the date that such State requests a waiver under this subsection to provide home or community-based services to individuals described in clause (iii), all other waivers (if any) granted under this subsection to such State meet the requirements of this subsection. (ii) The State demonstrates to the Secretary that approval of a waiver under this subsection with respect to individuals described in clause (iii) will not result in a material increase of the average amount of time that individuals with respect to whom a determination described in paragraph (1) has been made will need to wait to receive home or community-based services under any waiver granted under this subsection, as determined by the Secretary. (iii) The State establishes needs-based criteria, subject to the approval of the Secretary, to identify individuals for whom a determination described in paragraph (1) is not applicable, who will be eligible for home or community-based services under a waiver approved under this paragraph, and specifies the home or community-based services such individuals so eligible will receive. (iv) The State established needs-based criteria for determining whether an individual described in clause (iii) requires the level of care provided in a hospital, nursing facility, or an intermediate care facility for individuals with developmental disabilities under the State plan or under any waiver of such plan that are more stringent than the needs-based criteria established under clause (iii) for determining eligibility for home or community-based services. (v) The State attests that the State's average per capita expenditure for medical assistance under the State plan (or waiver of such plan) provided with respect to such individuals enrolled in a waiver under this paragraph will not exceed the State's average per capita expenditures for medical assistance for individuals receiving institutional care under the State plan (or waiver of such plan) for the duration that the waiver under this paragraph is in effect. (vi) The State provides to the Secretary data (in such form and manner as the Secretary may specify) regarding the number of individuals described in clause (i) with respect to a State seeking approval of a waiver under this subsection, to whom the State will make such services available under such waiver. (vii) The State agrees to provide to the Secretary, not less frequently than annually, data for purposes of paragraph (2)(E) (in such form and manner as the Secretary may specify) regarding, with respect to each preceding year in which a waiver under this subsection to provide home and community-based services to individuals described in clause (iii) was in effect— (I) the cost (as such term is defined by the Secretary) of such services furnished to individuals described in clause (iii), broken down by type of service; (II) with respect to each type of home and community-based service provided under the waiver, the length of time that such individuals have received such service; (III) a comparison between the data described in subclause (I) and any comparable data available with respect to individuals with respect to whom a determination described in paragraph (1) has been made and with respect to individuals receiving institutional care under this title; and (IV) the number of individuals who have received home and community-based services under the waiver during the preceding year..

(uu) Active duty relocated individual; home and community-Based services waiting list For purposes of subsection (a)(88) and this subsection: (1) The term active duty relocated individual means an individual— (A) who— (i) is enrolled under the State plan (or waiver of such plan); or (ii) with respect to an individual described in subparagraph (C)(ii), would be so enrolled pursuant to subsection (a)(10)(A)(ii)(VI) if such individual began receiving home and community-based services; (B) who— (i) is a member of the Armed Forces engaged in active duty service and is relocated to another State (in this subsection referred to as the ) by reason of such service; "military service relocation State" (ii) would be described in clause (i) except that the individual stopped being engaged in active duty service (including by reason of retirement from such service) and the last day on which the individual was engaged in active duty service occurred not more than 12 months ago; or (iii) is a dependent (as defined by the Secretary) of a member described in clause (i) or (ii) who relocates to the military service relocation State with such member; and (C) who— (i) was receiving home and community-based services (as defined in section 9817(a)(2)(B) of the American Rescue Plan Act of 2021) at the time of such relocation; or (ii) if the State maintains a home and community-based services waiting list, was on such home and community-based services waiting list at the time of such relocation.

(2) The term home and community-based services waiting list means, in the case of a State that has a limit on the number of individuals who may receive home and community-based services under section 1115(a), section 1915(c), or section 1915(j), a list maintained by such State of individuals who are requesting to receive such services under 1 or more such sections but for whom the State has not yet completed an assessment and rendered a decision with respect to the eligibility of such individuals to receive the relevant home and community-based services at the time a slot for such services becomes available due to such limit..

(2) A State study required under paragraph (1) shall include the following information (to the extent practicable) with respect to maternity, labor, and delivery services furnished by applicable hospitals located in the State: (A) An estimate of the cost of providing maternity, labor, and delivery services at applicable hospitals, based on the expenditures a representative sample of such hospitals incurred for providing such services during the 2 most recent years for which data is available. (B) An estimate of the cost of providing maternity, labor, and delivery services at applicable hospitals that ceased providing labor and delivery services within the past 5 years, based on the expenditures a representative sample of such hospitals incurred for providing such services during the 2 most recent years for which data is available. (C) To the extent data allows, an analysis of the extent to which geographic location, community demographics, and local economic factors (as defined by the Secretary) affect the cost of providing maternity, labor, and delivery services at applicable hospitals, including the cost of services that support the provision of maternity, labor, and delivery services. (D) The amounts applicable hospitals are paid for maternity, labor, and delivery services, by geographic location and hospital size, under— (i) Medicare; (ii) the State Medicaid program, including payment amounts for such services under fee-for-service payment arrangements and under managed care (as applicable); (iii) the State CHIP plan, including payment amounts for such services under fee-for-service payment arrangements and under managed care (as applicable); and (iv) private health insurance. (E) A comparative payment rate analysis— (i) comparing payment rates for maternity, labor, and delivery services (inclusive of all payments received by applicable hospitals for furnishing maternity, labor, and delivery services) under the State Medicaid fee-for-service program to such payment rates for such services under Medicare (as described in section 447.203(b)(3) of title 42, Code of Federal Regulations), other Federally-funded or State-funded programs (including, to the extent data is available, Medicaid managed care rates), and to the payment rates for such services, to the extent data is available, of private health insurers within geographic areas of the State; and (ii) analyzing different payment methods for such services, such as the use of bundled payments, quality incentives, and low-volume adjustments. (F) An evaluation, using such methodology and parameters established by the Secretary, of whether each hospital located in the State that furnishes maternity, labor, and delivery services is expected to experience in the next 3 years significant changes in particular expenditures or types of reimbursement for maternity, labor, and delivery services.

(2) State option to distribute unspent DSH allotments from prior years up to modified cap (A) If, for any Medicaid State plan rate year that begins on or after October 1, 2021, and before the date of enactment of this Act, a State did not spend the full amount of its Federal fiscal year allotment under section 1923 of the Social Security Act (42 U.S.C. 1396r–4) applicable to that State plan rate year, the State may use the unspent portion of such allotment to increase the amount of any payment adjustment made to a hospital for such rate year, provided that— (i) such payment adjustment (as so increased) is consistent with subsection (g) of such section (as amended by this section); and (ii) the total amount of all payment adjustments for the State plan rate year (as so increased) does not exceed the disproportionate share hospital allotment for the State and applicable Federal fiscal year under subsection (f) of such section. (B) A State shall not recoup any payment adjustment made by the State to a hospital for a Medicaid State plan rate year described in subparagraph (A) if such payment adjustment is consistent with section 1923(g) of such Act (42 U.S.C. 1396r–4(g)) as in effect on October 1, 2021. (C) Authority to permit retroactive modification of State plan amendments to allow for increases (i) Subject to paragraph (2), solely for the purpose of allowing a State to increase the amount of a payment adjustment to a hospital for a Medicaid State plan rate year described in subparagraph (A) pursuant to this paragraph, a State may retroactively modify a provision of the Medicaid State plan, a waiver of such plan, or a State plan amendment that relates to such rate year and the Secretary may approve such modification. (ii) A State may not submit a request for approval of a retroactive modification to a provision of the Medicaid State plan, a waiver of such plan, or a State plan amendment for a Medicaid State plan rate year after the date by which the State is required to submit the independent certified audit for that State plan rate year as required under section 1923(j)(2) of the Social Security Act (42 U.S.C. 1396r–4(j)(2)). (D) If a State increases a payment adjustment made to a hospital for a Medicaid State plan rate year pursuant to this paragraph, the State shall include information on such increased payment adjustment as part of the next annual report submitted by the State under section 1923(j)(1) of the Social Security Act (42 U.S.C. 1396r–4(j)(1)).

(F) In order to meet the requirement of section 1902(a)(54), a State shall require that any retail community pharmacy or applicable non-retail pharmacy in the State that receives any payment, reimbursement, administrative fee, discount, rebate, or other price concession related to the dispensing of covered outpatient drugs to individuals receiving benefits under this title, regardless of whether such payment, reimbursement, administrative fee, discount, rebate, or other price concession is received from the State or a managed care entity or other specified entity (as such terms are defined in section 1903(m)(9)(D)) directly or from a pharmacy benefit manager or another entity that has a contract with the State or a managed care entity or other specified entity (as so defined), shall respond to surveys conducted under this paragraph. (G) Information on national drug acquisition prices obtained under this paragraph shall be made publicly available in a form and manner to be determined by the Secretary and shall include at least the following: (i) The monthly response rate to the survey including a list of pharmacies not in compliance with subparagraph (F). (ii) The sampling methodology and number of pharmacies sampled monthly. (iii) Information on price concessions to pharmacies, including discounts, rebates, and other price concessions, to the extent that such information may be publicly released and has been collected by the Secretary as part of the survey. (H) Penalties (i) Subject to clauses (ii), (iii), and (iv), the Secretary shall enforce the provisions of this paragraph with respect to a pharmacy through the establishment of civil money penalties applicable to a retail community pharmacy or an applicable non-retail pharmacy. (ii) The Secretary shall impose a civil money penalty established under this subparagraph on a retail community pharmacy or applicable non-retail pharmacy if— (I) the retail pharmacy or applicable non-retail pharmacy refuses or otherwise fails to respond to a request for information about prices in connection with a survey under this subsection; (II) knowingly provides false information in response to such a survey; or (III) otherwise fails to comply with the requirements established under this paragraph. (iii) Parameters for penalties (I) A civil money penalty established under this subparagraph may be assessed with respect to each violation, and with respect to each non-compliant retail community pharmacy (including a pharmacy that is part of a chain) or non-compliant applicable non-retail pharmacy (including a pharmacy that is part of a chain), in an amount not to exceed $100,000 for each such violation. (II) In determining the amount of a civil money penalty imposed under this subparagraph, the Secretary may consider the size, business structure, and type of pharmacy involved, as well as the type of violation and other relevant factors, as determined appropriate by the Secretary. (iv) The provisions of section 1128A (other than subsections (a) and (b)) shall apply to a civil money penalty under this subparagraph in the same manner as such provisions apply to a civil money penalty or proceeding under section 1128A(a). (I) No State shall use pricing information reported by applicable non-retail pharmacies under subparagraph (A)(ii) to develop or inform payment methodologies for retail community pharmacies.;

(6) Transparent prescription drug pass-through pricing required (A) A contract between the State and a pharmacy benefit manager (referred to in this paragraph as a ), or a contract between the State and a managed care entity or other specified entity (as such terms are defined in section 1903(m)(9)(D) and collectively referred to in this paragraph as the ) that includes provisions making the entity responsible for coverage of covered outpatient drugs dispensed to individuals enrolled with the entity, shall require that payment for such drugs and related administrative services (as applicable), including payments made by a PBM on behalf of the State or entity, is based on a transparent prescription drug pass-through pricing model under which— "PBM" "entity" (i) any payment made by the entity or the PBM (as applicable) for such a drug— (I) is limited to— (II) is passed through in its entirety (except as reduced under Federal or State laws and regulations in response to instances of waste, fraud, or abuse) by the entity or PBM to the pharmacy or provider that dispenses the drug; and (III) is made in a manner that is consistent with sections 447.502, 447.512, 447.514, and 447.518 of title 42, Code of Federal Regulations (or any successor regulation) as if such requirements applied directly to the entity or the PBM, except that any payment by the entity or the PBM for the ingredient cost of such drug purchased by a covered entity (as defined in subsection (a)(5)(B)) may exceed the actual acquisition cost (as defined in 447.502 of title 42, Code of Federal Regulations, or any successor regulation) for such drug if— (ii) payment to the entity or the PBM (as applicable) for administrative services performed by the entity or PBM is limited to an administrative fee that reflects the fair market value (as defined by the Secretary) of such services; (iii) the entity or the PBM (as applicable) makes available to the State, and the Secretary upon request in a form and manner specified by the Secretary, all costs and payments related to covered outpatient drugs and accompanying administrative services (as described in clause (ii)) incurred, received, or made by the entity or the PBM, broken down (as specified by the Secretary), to the extent such costs and payments are attributable to an individual covered outpatient drug, by each such drug, including any ingredient costs, professional dispensing fees, administrative fees (as described in clause (ii)), post-sale and post-invoice fees, discounts, or related adjustments such as direct and indirect remuneration fees, and any and all other remuneration, as defined by the Secretary; and (iv) any form of spread pricing whereby any amount charged or claimed by the entity or the PBM (as applicable) that exceeds the amount paid to the pharmacies or providers on behalf of the State or entity, including any post-sale or post-invoice fees, discounts, or related adjustments such as direct and indirect remuneration fees or assessments, as defined by the Secretary, (after allowing for an administrative fee as described in clause (ii)) is not allowable for purposes of claiming Federal matching payments under this title. (B) The Secretary shall publish, not less frequently than on an annual basis and in a manner that does not disclose the identity of a particular covered entity or organization, information received by the Secretary pursuant to subparagraph (A)(i)(III)(cc) that is broken out by State and by each of the following categories of covered entity within each such State: (i) Covered entities described in subparagraph (A) of section 340B(a)(4) of the Public Health Service Act. (ii) Covered entities described in subparagraphs (B) through (K) of such section. (iii) Covered entities described in subparagraph (L) of such section. (iv) Covered entities described in subparagraph (M) of such section. (v) Covered entities described in subparagraph (N) of such section. (vi) Covered entities described in subparagraph (O) of such section.; and

(c) Subsequent study and report (1) Not later than September 30, 2028, the Secretary shall conduct a study to— (A) analyze, to the extent practicable, the criteria established by hospitals under the Acute Hospital Care at Home initiative to determine which individuals may be furnished services under such initiative; and (B) analyze and compare (both within and between hospitals participating in the initiative, and relative to comparable hospitals that do not participate in the initiative, for relevant parameters such as diagnosis-related groups)— (i) quality of care furnished to individuals with similar conditions and characteristics in the inpatient setting and through the Acute Hospital Care at Home initiative, including health outcomes, hospital readmission rates (including readmissions both within and beyond 30 days post-discharge), hospital mortality rates, length of stay, infection rates, composition of care team (including the types of labor used, such as contracted labor), the ratio of nursing staff, transfers from the hospital to the home, transfers from the home to the hospital (including the timing, frequency, and causes of such transfers), transfers and discharges to post-acute care settings (including the timing, frequency, and causes of such transfers and discharges), and patient and caregiver experience of care; (ii) clinical conditions treated and diagnosis-related groups of discharges from inpatient settings relative to discharges from the Acute Hospital Care at Home initiative; (iii) costs incurred by the hospital for furnishing care in inpatient settings relative to costs incurred by the hospital for furnishing care through the Acute Hospital Care at Home initiative, including costs relating to staffing, equipment, food, prescriptions, and other services, as determined by the Secretary; (iv) the quantity, mix, and intensity of services (such as in-person visits and virtual contacts with patients and the intensity of such services) furnished in inpatient settings relative to the Acute Hospital Care at Home initiative, and, to the extent practicable, the nature and extent of family or caregiver involvement; (v) socioeconomic information on individuals treated in comparable inpatient settings relative to the initiative, including racial and ethnic data, income, housing, geographic proximity to the brick-and-mortar facility and whether such individuals are dually eligible for benefits under this title and title XIX; and (vi) the quality of care, outcomes, costs, quantity and intensity of services, and other relevant metrics between individuals who entered into the Acute Hospital Care at Home initiative directly from an emergency department compared with individuals who entered into the Acute Hospital Care at Home initiative directly from an existing inpatient stay in a hospital.

(2) In conducting the study under paragraph (1), the Secretary shall, to the extent practicable, analyze and compare individuals who participate and do not participate in the initiative controlling for selection bias or other factors that may impact the reliability of data.

(3) Not later than September 30, 2028, the Secretary of Health and Human Services shall post on a website of the Centers for Medicare & Medicaid Services a report on the study conducted under paragraph (1).

(4) In addition to amounts otherwise available, there is appropriated to the Centers for Medicare & Medicaid Services Program Management Account for fiscal year 2025, out of any amounts in the Treasury not otherwise appropriated, $6,000,000, respectively, to remain available until expended, for purposes of carrying out this section..

(3) Provider directory accuracy (A) For plan year 2027 and subsequent plan years, each MA organization offering a specified MA plan (as defined in subparagraph (C)) shall, for each such plan offered by the organization— (i) maintain, on a publicly available internet website, an accurate provider directory that includes the information described in subparagraph (B); (ii) not less frequently than once every 90 days (or, in the case of a hospital or any other facility determined appropriate by the Secretary, at a lesser frequency specified by the Secretary but in no case less frequently than once every 12 months), verify the provider directory information of each provider listed in such directory and, if applicable, update such provider directory information; (iii) if the organization is unable to verify such information with respect to a provider, include in such directory an indication that the information of such provider may not be up to date; and (iv) remove a provider from such directory within 5 business days if the organization determines that the provider is no longer a provider participating in the network of such plan. (B) The information described in this subparagraph is information enrollees may need to access covered benefits from a provider with which such organization offering such plan has an agreement for furnishing items and services covered under such plan such as name, specialty, contact information, primary office or facility address, whether the provider is accepting new patients, accommodations for people with disabilities, cultural and linguistic capabilities, and telehealth capabilities. (C) In this paragraph, the term specified MA plan means— (i) a network-based plan (as defined in subsection (d)(5)(C)); or (ii) a Medicare Advantage private fee-for-service plan (as defined in section 1859(b)(2)) that meets the access standards under subsection (d)(4), in whole or in part, through entering into contracts or agreements as provided for under subparagraph (B) of such subsection..

(6) Provider directory accuracy analysis and reports (A) Beginning with plan years beginning on or after January 1, 2027, subject to subparagraph (C), a contract under this section with an MA organization shall require the organization, for each specified MA plan (as defined in section 1852(c)(3)(C)) offered by the organization to annually do the following: (i) Conduct an analysis estimating the accuracy of the provider directory information of such plan using a random sample of providers included in such provider directory as follows: (I) Such a random sample shall include a random sample of each specialty of providers with a high inaccuracy rate of provider directory information relative to other specialties of providers, as determined by the Secretary. (II) For purposes of subclause (I), one type of specialty may be providers specializing in mental health or substance use disorder treatment. (ii) Submit to the Secretary a report containing the results of the analysis conducted under clause (i), including an accuracy score for such provider directory information (as determined using a plan verification method specified by the Secretary under subparagraph (B)(i)). (B) Determination of accuracy score (i) The Secretary shall specify plan verification methods, such as using telephonic verification or other approaches using data sources maintained by an MA organization or using publicly available data sets, that MA organizations may use for estimating accuracy scores of the provider directory information of specified MA plans offered by such organizations. (ii) With respect to each such method specified by the Secretary as described in clause (i), the Secretary shall specify a methodology for MA organizations to use in estimating such accuracy scores. Each such methodology shall take into account the administrative burden on plans and providers and the relative importance of certain provider directory information on enrollee ability to access care. (C) The Secretary may waive the requirements of this paragraph in the case of a specified MA plan with low enrollment (as defined by the Secretary). (D) Beginning with plan years beginning on or after January 1, 2028, the Secretary shall post accuracy scores (as reported under subparagraph (A)(ii)), in a machine readable file, on the internet website of the Centers for Medicare & Medicaid Services.. (B) Section 1851(d)(4) of the Social Security Act (42 U.S.C. 1395w–21(d)(4)) is amended by adding at the end the following new subparagraph: (F) Beginning with plan years beginning on or after January 1, 2028, the accuracy score of the plan’s provider directory (as reported under section 1857(e)(6)(A)(ii)) listed prominently on the plan’s provider directory.. (C) 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, $4,000,000 for fiscal year 2025, to remain available until expended, to carry out the amendments made by this paragraph.

(e) Essential retail pharmacies (1) With respect to plan years beginning on or after January 1, 2028, the Secretary shall publish reports, at least once every 2 years until 2034, and periodically thereafter, that provide information, to the extent feasible, on— (A) trends in ingredient cost reimbursement, dispensing fees, incentive payments and other fees paid by PDP sponsors offering prescription drug plans and MA organizations offering MA–PD plans under this part to essential retail pharmacies (as defined in paragraph (2)) with respect to the dispensing of covered part D drugs, including a comparison of such trends between essential retail pharmacies and pharmacies that are not essential retail pharmacies; (B) trends in amounts paid to PDP sponsors offering prescription drug plans and MA organizations offering MA–PD plans under this part by essential retail pharmacies with respect to the dispensing of covered part D drugs, including a comparison of such trends between essential retail pharmacies and pharmacies that are not essential retail pharmacies; (C) trends in essential retail pharmacy participation in pharmacy networks and preferred pharmacy networks for prescription drug plans offered by PDP sponsors and MA–PD plans offered by MA organizations under this part, including a comparison of such trends between essential retail pharmacies and pharmacies that are not essential retail pharmacies; (D) trends in the number of essential retail pharmacies, including variation in such trends by geographic region or other factors; (E) a comparison of cost-sharing for covered part D drugs dispensed by essential retail pharmacies that are network pharmacies for prescription drug plans offered by PDP sponsors and MA–PD plans offered by MA organizations under this part and cost-sharing for covered part D drugs dispensed by other network pharmacies for such plans located in similar geographic areas that are not essential retail pharmacies; (F) a comparison of the volume of covered part D drugs dispensed by essential retail pharmacies that are network pharmacies for prescription drug plans offered by PDP sponsors and MA–PD plans offered by MA organizations under this part and such volume of dispensing by network pharmacies for such plans located in similar geographic areas that are not essential retail pharmacies, including information on any patterns or trends in such comparison specific to certain types of covered part D drugs, such as generic drugs or drugs specified as specialty drugs by a PDP sponsor under a prescription drug plan or an MA organization under an MA–PD plan; and (G) a comparison of the information described in subparagraphs (A) through (F) between essential retail pharmacies that are network pharmacies for prescription drug plans offered by PDP sponsors under this part and essential retail pharmacies that are network pharmacies for MA–PD plans offered by MA organizations under this part.

(2) In this subsection, the term essential retail pharmacy means, with respect to a plan year, a retail pharmacy that— (A) is not a pharmacy that is an affiliate as defined in paragraph (4); and (B) is located in— (i) a medically underserved area (as designated pursuant to section 330(b)(3)(A) of the Public Health Service Act); (ii) a rural area in which there is no other retail pharmacy within 10 miles, as determined by the Secretary; (iii) a suburban area in which there is no other retail pharmacy within 2 miles, as determined by the Secretary; or (iv) an urban area in which there is no other retail pharmacy within 1 mile, as determined by the Secretary.

(3) List of essential retail pharmacies (A) For each plan year (beginning with plan year 2028), the Secretary shall publish, on a publicly available internet website of the Centers for Medicare & Medicaid Services, a list of pharmacies that meet the criteria described in subparagraphs (A) and (B) of paragraph (2) to be considered an essential retail pharmacy. (B) For each plan year (beginning with plan year 2028), each PDP sponsor offering a prescription drug plan and each MA organization offering an MA–PD plan shall submit to the Secretary, for the purposes of determining retail pharmacies that meet the criterion specified in subparagraph (A) of paragraph (2), a list of retail pharmacies that are affiliates of such sponsor or organization, or are affiliates of a pharmacy benefit manager acting on behalf of such sponsor or organization, at a time, and in a form and manner, specified by the Secretary. (C) For each plan year beginning with plan year 2027, each PDP sponsor offering a prescription drug plan and each MA organization offering an MA–PD plan under this part shall submit to the Secretary information on incentive payments and other fees paid by such sponsor or organization to pharmacies, insofar as any such payments or fees are not otherwise reported, at a time, and in a form and manner, specified by the Secretary. (D) Notwithstanding any other provision of law, the Secretary may implement this paragraph by program instruction or otherwise. (E) of title 44, United States Code, shall not apply to the implementation of this paragraph. (Chapter 35)

(4) In this subsection, the terms and have the meaning given those terms in section 1860D–12(h)(7). affiliate,pharmacy benefit manager.

(F) Enforcement of standards for reasonable and relevant contract terms and conditions (i) Allegation submission process (I) Not later than January 1, 2028, the Secretary shall establish a process through which a pharmacy may submit to the Secretary an allegation of a violation by a PDP sponsor offering a prescription drug plan of the standards for reasonable and relevant contract terms and conditions under subparagraph (A)(ii), or of subclause (VIII) of this clause. (II) Frequency of submission (III) A PDP sponsor subject to an allegation under this clause— (IV) The Secretary shall establish a standardized template for pharmacies to use for the submission of allegations described in subclause (I). Such template shall require that the submission include a certification by the pharmacy that the information included is accurate, complete, and true to the best of the knowledge, information, and belief of such pharmacy. (V) In the case where the Secretary determines that a pharmacy has submitted frivolous allegations under this clause on a routine basis, the Secretary may temporarily prohibit such pharmacy from using the allegation submission process under this clause, as determined appropriate by the Secretary. (VI) Allegations submitted under this clause shall be exempt from disclosure under section 552 of title 5, United States Code. (VII) Nothing in this clause shall be construed as limiting the ability of a pharmacy to pursue other legal actions or remedies, consistent with applicable Federal or State law, with respect to a potential violation of a requirement described in this subparagraph. (VIII) Consistent with applicable Federal or State law, a PDP sponsor shall not— (ii) The Secretary shall investigate, as determined appropriate by the Secretary, allegations submitted pursuant to clause (i). (iii) Enforcement (I) In the case where the Secretary determines that a PDP sponsor offering a prescription drug plan has violated the standards for reasonable and relevant contract terms and conditions under subparagraph (A)(ii), the Secretary may use authorities under sections 1857(g) and 1860D–12(b)(3)(E) to impose civil monetary penalties or other intermediate sanctions. (II) The provisions of section 1128A (other than subsections (a) and (b)) shall apply to a civil monetary penalty under this clause in the same manner as such provisions apply to a penalty or proceeding under section 1128A(a)..

(h) Requirements relating to pharmacy benefit managers For plan years beginning on or after January 1, 2028: (1) 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: (A) No income other than bona fide service fees (i) 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). (ii) 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 (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. "bona fide service fee" (iii) 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. (iv) 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. (v) 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. (vi) The 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) The 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) , 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; generic drug (II) , 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 (III) ; specialty drug (IV) ; and rebate (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) Not later than July 1 of each year, beginning in 2028, 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— (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: (III) Where a drug approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act (referred to in this subclause as the ) is covered by the plan, the following information: "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: (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: (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) 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. (II) A written explanation under subclause (I) shall— (III) 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. (D) Audit rights (i) Not less than once a year, at the request of the PDP sponsor, the pharmacy benefit manager shall allow for an audit of the pharmacy benefit manager to ensure compliance with all terms and conditions under the written agreement described in this paragraph and the accuracy of information reported under subparagraph (C). (ii) 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. (iii) 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. (iv) 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. (v) 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.

(2) Enforcement (A) Each 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) 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). (C) Consistent 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) 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. (B) Notwithstanding any other provision of law, the Secretary may implement this paragraph by program instruction or otherwise.

(4) Nothing 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) Not later than June 1, 2027, the Secretary shall specify standard, machine-readable formats for pharmacy benefit managers to submit annual reports required under paragraph (1)(C)(i). (B) Notwithstanding any other provision of law, the Secretary may implement this paragraph by program instruction or otherwise.

(6) Confidentiality (A) 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: (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) 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— (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) For purposes of this subsection: (A) The term affiliate means, with respect to any pharmacy benefit manager or PDP sponsor, any entity that, directly or indirectly— (i) owns or is owned by, controls or is controlled by, or is otherwise related in any ownership structure to such pharmacy benefit manager or PDP sponsor; or (ii) acts as a contractor, principal, or agent to such pharmacy benefit manager or PDP sponsor, insofar as such contractor, principal, or agent performs any of the functions described under subparagraph (C). (B) 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— (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) 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".

(1) The Comptroller General of the United States (in this subsection referred to as the ) 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: "Comptroller General" (A) 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— (i) pharmacy benefit managers; (ii) PDP sponsors offering prescription drug plans and Medicare Advantage organizations offering MA–PD plans; (iii) drug wholesalers; (iv) pharmacies; (v) manufacturers; (vi) pharmacy services administrative organizations; (vii) brokers, auditors, consultants, and other entities that— (I) advise PDP sponsors offering prescription drug plans and Medicare Advantage organizations offering MA–PD plans regarding pharmacy benefits; or (II) review PDP sponsor and Medicare Advantage organization contracts with pharmacy benefit managers; and (viii) 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). (B) The primary business models and compensation structures for each category of intermediary described in subparagraph (A). (C) 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. (D) 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. (E) 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.; 42 U.S.C. 1396 et seq.) and the Medicaid program under title XIX of such Act (). (F) 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. (G) Other issues determined to be relevant and appropriate by the Comptroller General.

(23) Use of unique health identifiers; attestation (A) No payment may be made under this subsection (or under an applicable payment system pursuant to paragraph (21)) for items and services furnished on or after January 1, 2026, by an off-campus outpatient department of a provider (as defined in subparagraph (C)) unless— (i) such department has obtained, and such items and services are billed under, a standard unique health identifier for health care providers (as described in section 1173(b)) that is separate from such identifier for such provider; (ii) such provider has submitted to the Secretary, during the 2-year period ending on the date such items and services are so furnished, an initial provider-based status attestation that such department is compliant with the requirements described in section 413.65 of title 42, Code of Federal Regulations (or a successor regulation); and (iii) after such provider has submitted an attestation under clause (ii), such provider has submitted a subsequent attestation within the timeframe specified by the Secretary. (B) Not later than 1 year after the date of enactment of this paragraph, the Secretary shall, through notice and comment rulemaking, establish a process for each provider with an off-campus outpatient department of a provider to submit an initial and subsequent attestation pursuant to clauses (ii) and (iii), respectively, of subparagraph (A), and for the Secretary to review each such attestation and determine, through site visits, remote audits, or other means (as determined appropriate by the Secretary), whether such department is compliant with the requirements described in such subparagraph. (C) For purposes of this paragraph, the term off-campus outpatient department of a provider means a department of a provider (as defined in section 413.65 of title 42, Code of Federal Regulations, or any successor regulation) that is not located— (i) on the campus (as defined in such section) of such provider; or (ii) within the distance (described in such definition of campus) from a remote location of a hospital facility (as defined in such section)..

(f) Cybersecurity reporting (1) Notification (A) The program’s network administrator receiving Federal funding pursuant to subsection (a) shall report to the Assistant Secretary, in a manner that protects personal privacy, consistent with applicable Federal and State privacy laws— (i) any identified cybersecurity vulnerabilities to the program within a reasonable amount of time after identification of such a vulnerability; and (ii) any identified cybersecurity incidents to the program within a reasonable amount of time after identification of such incident. (B) Local and regional crisis centers participating in the program shall report to the program’s network administrator identified under subparagraph (A), in a manner that protects personal privacy, consistent with applicable Federal and State privacy laws— (i) any identified cybersecurity vulnerabilities to the program within a reasonable amount of time after identification of such vulnerability; and (ii) any identified cybersecurity incidents to the program within a reasonable amount of time after identification of such incident.

(2) If the program’s network administrator receiving funding pursuant to subsection (a) discovers, or is informed by a local or regional crisis center pursuant to paragraph (1)(B) of, a cybersecurity vulnerability or incident, within a reasonable amount of time after such discovery or receipt of information, such entity shall report the vulnerability or incident to the Assistant Secretary.

(3) Clarification (A) Oversight (i) Except as provided in clause (ii), local and regional crisis centers participating in the program shall oversee all technology each center employs in the provision of services as a participant in the program. (ii) The program’s network administrator receiving Federal funding pursuant to subsection (a) shall oversee the technology each crisis center employs in the provision of services as a participant in the program if such oversight responsibilities are established in the applicable network participation agreement. (B) The cybersecurity incident reporting requirements under this subsection shall supplement, and not supplant, cybersecurity incident reporting requirements under other provisions of applicable Federal law that are in effect on the date of the enactment of the ..

(g) Working groups (1) The Committee may establish working groups for purposes of carrying out the duties described in subsection (e). Any such working group shall be composed of members of the Committee (or the designees of such members) and may hold such meetings as are necessary to carry out the duties delegated to the working group.

(2) Additional federal interagency work group on fentanyl contamination of illegal drugs (A) The Secretary, acting through the Committee, shall establish a Federal Interagency Work Group on Fentanyl Contamination of Illegal Drugs (referred to in this paragraph as the ) consisting of representatives from relevant Federal departments and agencies on the Committee. "Work Group" (B) The Work Group shall consult with relevant stakeholders and subject matter experts, including— (i) State, Tribal, and local subject matter experts in reducing, preventing, and responding to drug overdose caused by fentanyl contamination of illicit drugs; and (ii) family members of both adults and youth who have overdosed by fentanyl-contaminated illicit drugs. (C) The Work Group shall— (i) examine Federal efforts to reduce and prevent drug overdose by fentanyl-contaminated illicit drugs; (ii) identify strategies to improve State, Tribal, and local responses to overdose by fentanyl-contaminated illicit drugs; (iii) coordinate with the Secretary, as appropriate, in carrying out activities to raise public awareness of synthetic opioids and other emerging drug use and misuse issues; (iv) make recommendations to Congress for improving Federal programs, including with respect to the coordination of efforts across such programs; and (v) make recommendations for educating youth on the potency and dangers of drugs contaminated by fentanyl. (D) The Work Group shall annually prepare and submit to the Secretary, the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce and the Committee on Education and the Workforce of the House of Representatives, a report on the activities carried out by the Work Group under subparagraph (C), including recommendations to reduce and prevent drug overdose by fentanyl contamination of illegal drugs, in all populations, and specifically among youth at risk for substance misuse.; and

SEC. 317W.. Wastewater surveillance for pathogen detection (a) Wastewater surveillance system The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in coordination with other Federal departments and agencies, shall award grants, contracts, or cooperative agreements to eligible entities to establish, maintain, or improve activities related to the detection and monitoring of infectious diseases through wastewater for public health emergency preparedness and response purposes. (b) Eligible entities To be eligible to receive an award under this section, an entity shall— (1) be a State, Tribal, or local health department, or a partnership between such a health department and other public and private entities; and

(2) submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may reasonably require, which shall include— (A) a description of activities proposed to be carried out pursuant to an award under subsection (a); (B) factors such entity proposes to use to select wastewater sampling sites; (C) factors such entity proposes to use to determine whether a response to findings from such wastewater sampling may be warranted, and a plan for responding, as appropriate, consistent with applicable plans developed by such entity pursuant to section 319C–1; (D) a plan to sustain such wastewater surveillance activities described in such application following the conclusion of the award period; and (E) any additional information the Secretary may require. (c) Consideration In making awards under subsection (a), the Secretary may give priority to eligible entities that have submitted an application that— (1) details plans to provide public access to deidentified data generated through such wastewater surveillance activities in a manner that allows for comparison to such data generated by other recipients of an award under subsection (a); and

(2) provides an assessment of community needs related to ongoing infectious disease monitoring, including estimates of the incidence and prevalence of infectious diseases that can be detected in wastewater and availability, at the time of the application, of other forms of infectious disease detection in the jurisdiction. (d) Use of funds An eligible entity shall, as appropriate, use amounts awarded under this section to— (1) establish or enhance existing capacity and capabilities to conduct wastewater sampling, testing, and related analysis;

(2) conduct wastewater surveillance, as appropriate, in areas or facilities with increased risk of infectious disease outbreaks and limited ability to utilize other forms of infectious disease detection, such as at individual facilities, institutions, and locations in rural areas or areas in which wastewater is not treated through the relevant local utility of the jurisdiction; and

(3) implement projects that use evidence-based or innovative practices to conduct wastewater surveillance activities. (e) Partnerships In carrying out activities under this section, eligible entities shall identify opportunities to partner with other public or private entities to leverage relevant capabilities maintained by such entities, as appropriate and consistent with this section. (f) Technical assistance The Secretary, in consultation with the heads of other applicable Federal agencies and departments, as appropriate, shall provide technical assistance to recipients of awards under this section to facilitate the planning, development, and implementation of activities described in subsection (d). (g) Authorization of appropriations To carry out this section, there is authorized to be appropriated $20,000,000 for each of fiscal years 2025 and 2026, to remain available through December 31, 2026..

SEC. 319B.. Improving development and distribution of diagnostic tests (a) Diagnostic testing preparedness plan The Secretary shall develop, make publicly available, not later than 1 year after the date of enactment of the Pandemic and All-Hazards Preparedness and Response Act, and update not less frequently than every 3 years thereafter, a plan for the rapid development, validation, authorization, manufacture, procurement, and distribution of diagnostic tests, and for rapid scaling of testing capacity, in response to chemical, biological, radiological, or nuclear threats, including emerging infectious diseases, for which a public health emergency is declared under section 319, or that has significant potential to cause such a public health emergency. (b) Purposes The purpose of the plan under subsection (a) shall be to— (1) facilitate the development and utilization of diagnostic tests;

(2) describe the processes for the rapid development, validation, authorization, manufacture, procurement, and distribution of diagnostic tests, and for rapid scaling of testing capacity; and

(3) facilitate coordination and collaboration among public and private entities to improve the rapid development and utilization of diagnostic testing during a public health emergency. (c) Considerations The plan under subsection (a) shall take into consideration— (1) domestic capacity, including any such capacity established through partnerships with public and private entities pursuant to subsection (e), to support the development, validation, manufacture, procurement, and distribution of tests, and the rapid scaling of testing capacity;

(2) novel technologies and platforms that— (A) may be used to improve testing capabilities, including— (i) high-throughput laboratory diagnostics; (ii) point-of-care diagnostics; and (iii) rapid at-home diagnostics; (B) improve the accessibility of diagnostic tests; and (C) facilitate the development and manufacture of diagnostic tests;

(3) medical supply needs related to testing, including diagnostic testing, equipment, supplies, and component parts, and any potential vulnerabilities related to the availability of such medical supplies and related planning needs, consistent with section 2811(b)(4)(J);

(4) strategies for the rapid and efficient distribution of tests locally, regionally, or nationwide and appropriate scaling of laboratory testing capacity; and

(5) assessment of such strategies through drills and operational exercises carried out under section 2811(b)(4)(G), as appropriate. (d) Coordination To inform the development and update of the plan under subsection (a), and in carrying out activities to implement such plan, the Secretary shall coordinate with industry, such as device manufacturers, clinical and reference laboratories, and medical product distributors, States, local governmental entities, Indian Tribes and Tribal organizations, and other relevant public and private entities. (e) Capacity building The Secretary may contract with public and private entities, as appropriate, to increase domestic capacity in the rapid development, validation, authorization, manufacture, procurement, and distribution of diagnostic tests, as appropriate, to State, local, and Tribal health departments and other appropriate entities for immediate public health response activities to address an infectious disease with respect to which a public health emergency is declared under section 319, or that has significant potential to cause such a public health emergency..

(b) Advisory council (1) The Secretary may continue the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, referred to in this subsection as the . "Advisory Council"

(2) The Advisory Council shall advise and provide information and recommendations to the Secretary, acting through the Task Force established under subsection (a), regarding Federal programs and activities intended to reduce or combat antimicrobial-resistant bacteria or fungi that may present a public health threat and improve capabilities to prevent, diagnose, mitigate, or treat such resistance. Such advice, information, and recommendations may be related to improving Federal efforts related to factors described in subsection (a)(3) and other topics related to antimicrobial resistance, as appropriate.

(3) Meetings and coordination (A) The Advisory Council shall meet not less frequently than biannually and, to the extent practicable, in coordination with meetings of the task force established under subsection (a). (B) The Advisory Council shall, to the greatest extent practicable, coordinate activities carried out by the Council with the task force established under subsection (a).

(4) of title 5, United States Code, shall apply to the activities and duties of the Advisory Council. (Chapter 10)

(5) Sunset (A) The Advisory Council under this subsection shall terminate on December 31, 2026. (B) Not later than October 1, 2026, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that includes a recommendation on whether the Advisory Council should be extended, and identifying whether there are other committees, councils, or task forces that have overlapping or similar duties to that of the Advisory Council, and whether such committees, councils, or task forces should be combined, restructured, or eliminated, including with respect to the task force established under subsection (a).; and

(c) Limitations on countries of concern conducting certain research (1) The Secretary of Health and Human Services (referred to in this subsection as the ) shall not fund research that may reasonably be anticipated to involve the creation, transfer, and use of enhanced pathogens of pandemic potential or biological agents or toxins listed pursuant to section 351A(a)(1) of the Public Health Service Act if such research is conducted by a foreign entity at a facility located in a country that is determined to be a country of concern as defined in paragraph (2). "Secretary"

(2) Countries of concern (A) For purposes of this subsection, a means the People’s Republic of China, the Democratic People’s Republic of Korea, the Russian Federation, the Islamic Republic of Iran, and any other country as determined pursuant to subparagraph (B). country of concern (B) The Director of National Intelligence (referred to in this subsection as the ) shall, in consultation with the Secretary, add additional countries of concern for purposes of paragraph (1), only if— "Director" (i) the Director determines that evidence exists that a country has malicious intent related to the creation, enhancement, transfer, or use of pathogens of pandemic potential or biological agents or toxins listed pursuant to such section 351A(a)(1); and (ii) in a manner that does not compromise national security, the Director provides such evidence in a report submitted to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives. (C) Paragraph (1) shall not take effect with respect to a country of concern identified under subparagraph (B) until the date that is 15 days after the date on which the Director submits the report described in subparagraph (B)(ii).

(3) Clarification (A) The requirement of paragraph (1) may be waived by the President for the duration of the initial response to an outbreak of a novel emerging infectious disease if the President determines that such requirement impedes the ability of the Federal Government to immediately respond to such outbreak. (B) The President shall notify such committees of Congress not later than 48 hours after exercising the waiver under subparagraph (A), and shall provide updates to such committees related to the use of such waiver every 15 days thereafter.

(4) The limitation under this subsection shall expire on December 31, 2026..

(1) Procedures for correcting submissions (A) Requests initially submitted under section 319F–4 (i) In the case of a request for compensation submitted under section 319F–4 of the Public Health Service Act (42 U.S.C. 247d–6e) for an injury or death related to a medical product for active immunization to prevent coronavirus disease 2019 that the Secretary determines to be ineligible pursuant to subsection (b)(4)(B) of such section 319F–4, the Secretary shall, not later than 30 days after such determination, notify the individual submitting the request of such determination. (ii) An individual who receives a notification described in clause (i) shall be eligible to submit a petition to the United States Court of Federal Claims under section 2111 of the Public Health Service Act (42 U.S.C. 300aa–11; 42 U.S.C. 247d–6e) with respect to the same medical product administration claimed in the request submitted under section 319F–4 of such Act (), provided such petition is submitted not later than the later of— (I) 1 year after receiving such notification under clause (i); or (II) the last date on which the individual otherwise would be eligible to submit a petition relating to such injury, as specified in section 2116 of such Act (42 U.S.C. 300aa–16). (iii) To be eligible to submit a petition in accordance with clause (ii), the petitioner shall have submitted the request that was determined to be ineligible as described in clause (i) not later than the applicable deadline for filing a petition under such section 2116. (B) Requests initially submitted under section 2111 (i) If a special master determines that— (I) a petition submitted under section 2111 of the Public Health Service Act (42 U.S.C. 300aa–11; 42 U.S.C. 300aa–10 et seq.; 42 U.S.C. 300aa–14) related to a medical product for active immunization to prevent coronavirus disease 2019 that is ineligible for the program under subtitle 2 of title XXI of the Public Health Service Act () because it relates to a medical product administered at a time when the medical product was not included in the table under section 2114 of such Act (); and (II) the medical product was administered when it was a covered countermeasure subject to a declaration under section 319F–3(b) of such Act (42 U.S.C. 247d–6d(b)), (ii) An individual who receives a notification described in clause (i) shall be eligible to submit a request for compensation under section 319F–4(b) of the Public Health Service Act (42 U.S.C. 247d–6e(b)) with respect to the same medical product administration claimed in the petition submitted under section 2111 of such Act (42 U.S.C. 300aa–11)— (I) not later than 1 year after receiving such notification; or (II) in the case that the notification is issued after judicial review of the petition under subsection (e) or (f) of section 2112 of such Act (42 U.S.C. 300aa–12), not later than 1 year after the judgment of the United States Court of Federal Claims or the mandate is issued by the United States Court of Appeals for the Federal Circuit pursuant to such subsection (e) or (f). (iii) To be eligible to submit a request for compensation in accordance with clause (ii), the individual submitting the request shall have submitted the petition under section 2111 of the Public Health Service Act (42 U.S.C. 300aa–11) that was determined to be ineligible not later than 1 year after the date of administration of the medical product.

SEC. 409K.. Down syndrome research (a) In general The Director of NIH shall carry out a program of research, training, and investigation related to Down syndrome to be known as the or the . "INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE Project" "INCLUDE Project" (b) Program elements The program under subsection (a) shall include— (1) high-risk, high reward research on the effects of trisomy 21 on human development and health;

(2) promoting research for participants with Down syndrome across the lifespan, including cohort studies to facilitate improved understanding of Down syndrome and co-occurring conditions and development of new interventions;

(3) expanding the number of clinical trials that are inclusive of, or expressly for, participants with Down syndrome, including novel biomedical and pharmacological interventions and other therapies designed to promote or enhance activities of daily living;

(4) research on the biological mechanisms in individuals with Down syndrome pertaining to structural, functional, and behavioral anomalies and dysfunction as well as stunted growth;

(5) supporting research to improve diagnosis and treatment of conditions co-occurring with Down syndrome, including the identification of biomarkers related to risk factors, diagnosis, and clinical research and therapeutics;

(6) research on the causes of increased prevalence, and concurrent treatment, of co-occurring conditions, such as Alzheimer’s disease and related dementias and autoimmunity, in individuals with Down syndrome; and

(7) research, training, and investigation on improving the quality of life of individuals with Down syndrome and their families. (c) Coordination; Prioritizing nonduplicative research The Director of NIH shall ensure that— (1) the programs and activities of the institutes and centers of the National Institutes of Health relating to Down syndrome and co-occurring conditions are coordinated, including through the Office of the Director of NIH and priority-setting reviews conducted pursuant to section 402(b)(3); and

(2) such institutes and centers, prioritize, as appropriate, Down syndrome research that does not duplicate existing research activities of the National Institutes of Health. (d) Consultation with stakeholders In carrying out activities under this section, the Director of NIH shall, as appropriate and to the maximum extent feasible, consult with relevant stakeholders, including patient advocates, to ensure that such activities take into consideration the needs of individuals with Down syndrome. (e) Biennial reports to Congress (1) The Director of NIH shall submit, on a biennial basis, to the Committee on Energy and Commerce and the Subcommittee on Labor, Health and Human Services, Education, and Related Agencies of the Committee on Appropriations of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and the Subcommittee on Labor, Health and Human Services, Education, and Related Agencies of the Committee on Appropriations of the Senate, a report that catalogs the research conducted or supported under this section.

(2) Each report under paragraph (1) shall include— (A) identification of the institute or center involved; (B) a statement of whether the research is or was being carried out directly by such institute or center or by multiple institutes and centers; and (C) identification of any resulting real-world evidence that is or may be used for clinical research and medical care for patients with Down syndrome..

(d) Registration fees (1) The Secretary may collect registration fees from any member of the Organ Procurement and Transplantation Network for each transplant candidate such member places on the list described in subsection (b)(2)(A)(i). Such registration fees shall be collected and distributed only to support the operation of the Organ Procurement and Transplantation Network. Such registration fees are authorized to remain available until expended.

(2) The Secretary may collect the registration fees under paragraph (1) directly or through awards made under subsection (b)(1)(A).

(3) Any amounts collected under this subsection shall— (A) be credited to the currently applicable appropriation, account, or fund of the Department of Health and Human Services as discretionary offsetting collections; and (B) be available, only to the extent and in the amounts provided in advance in appropriations Acts, to distribute such fees among awardees described in subsection (b)(1)(A).

(4) The Secretary shall— (A) promptly post on the website of the Organ Procurement and Transplantation Network— (i) the amount of registration fees collected under this subsection from each member of the Organ Procurement and Transplantation Network; and (ii) a list of activities such fees are used to support; and (B) update the information posted pursuant to subparagraph (A), as applicable for each calendar quarter for which fees are collected under paragraph (1).

(5) Not later than 2 years after the date of enactment of this subsection, the Comptroller General of the United States shall, to the extent data are available— (A) conduct a review concerning the activities under this subsection; and (B) submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Finance of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report on such review, including related recommendations, as applicable.

(6) The authority to collect registration fees under paragraph (1) shall expire on the date that is 3 years after the date of enactment of the Health Improvements, Extenders, and Reauthorizations Act..

(1) GAO study (A) The Comptroller General of the United States shall conduct a study of the effectiveness of awarding rare pediatric disease priority vouchers under section 529 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ff), as amended by subsection (a), in the development of human drug products that treat or prevent rare pediatric diseases (as defined in such section 529). (B) In conducting the study under subparagraph (A), the Comptroller General shall examine the following: (i) The indications for each drug or biological product that— (I) is the subject of a rare pediatric disease product application (as defined in section 529 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ff)) for which a priority review voucher was awarded; and (II) was approved under section 505 of the Federal Food, Drug, and Cosmetic Act (42 U.S.C. 355; 42 U.S.C. 262) or licensed under section 351 of the Public Health Service Act (). (ii) Whether, and to what extent, an unmet need related to the treatment or prevention of a rare pediatric disease was met through the approval or licensure of such a drug or biological product. (iii) The size of the company to which a priority review voucher was awarded under section 529 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ff) for such a drug or biological product. (iv) The value of such priority review voucher if transferred. (v) Identification of each drug for which a priority review voucher awarded under such section 529 was used. (vi) The size of the company using each priority review voucher awarded under such section 529. (vii) The length of the period of time between the date on which a priority review voucher was awarded under such section 529 and the date on which it was used. (viii) Whether, and to what extent, an unmet need related to the treatment or prevention of a rare pediatric disease was met through the approval under section 505 of the Federal Food, Drug, and Cosmetic Act (42 U.S.C. 355; 42 U.S.C. 262) or licensure under section 351 of the Public Health Service Act () of a drug for which a priority review voucher was used. (ix) Whether, and to what extent, companies were motivated by the availability of priority review vouchers under section 529 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ff) to attempt to develop a drug for a rare pediatric disease. (x) Whether, and to what extent, pediatric review vouchers awarded under such section were successful in stimulating development and expedited patient access to drug products for treatment or prevention of a rare pediatric disease that wouldn’t otherwise take place without the incentive provided by such vouchers. (xi) The impact of such priority review vouchers on the workload, review process, and public health prioritization efforts of the Food and Drug Administration. (xii) Any other incentives in Federal law that exist for companies developing drugs or biological products described in clause (i).

SEC. 1015. Abraham Accords Office (a) In general The Secretary, acting through the Commissioner of Food and Drugs, shall establish within the Food and Drug Administration an office, to be known as the Abraham Accords Office, to be headed by a director. (b) Office Not later than 2 years after the date of enactment of this section, the Secretary shall— (1) in consultation with the governments of Abraham Accords countries, as well as appropriate United States Government diplomatic and security personnel— (A) select the location of the Abraham Accords Office in an Abraham Accords country; and (B) establish such office; and

(2) assign to such office such personnel of the Food and Drug Administration as the Secretary determines necessary to carry out the functions of such office. (c) Duties The Secretary, acting through the Director of the Abraham Accords Office, shall— (1) after the Abraham Accords Office is established— (A) as part of the Food and Drug Administration’s work to strengthen the international oversight of regulated commodities, provide technical assistance to regulatory partners in Abraham Accords countries on strengthening regulatory oversight and converging regulatory requirements for the oversight of regulated products, including good manufacturing practices and other issues relevant to manufacturing medical products that are regulated by the Food and Drug Administration; and (B) facilitate interactions between the Food and Drug Administration and interested parties in Abraham Accords countries, including by sharing relevant information regarding United States regulatory pathways with such parties, and facilitate feedback on the research, development, and manufacturing of products regulated in accordance with this Act; and

(2) carry out other functions and activities as the Secretary determines to be necessary to carry out this section. (d) Abraham Accords country defined In this section, the term Abraham Accords country means a country identified by the Department of State as having signed the Abraham Accords Declaration. (e) National security Nothing in this section shall be construed to require any action inconsistent with a national security recommendation provided by the Federal Government..

SEC. 2799A–11.. Oversight of entities that provide pharmacy benefit management services (a) In general For plan years beginning on or after the date that is 30 months after the date of enactment of this section (referred to in this subsection and subsection (b) as the ), a group health plan or a health insurance issuer offering group health insurance coverage, or an entity providing pharmacy benefit management services on behalf of such a plan or issuer, shall not enter into a contract, including an extension or renewal of a contract, entered into on or after the effective date, with an applicable entity unless such applicable entity agrees to— "effective date" (1) not limit or delay the disclosure of information to the group health plan (including such a plan offered through a health insurance issuer) in such a manner that prevents an entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer offering group health insurance coverage from making the reports described in subsection (b); and

(2) provide the entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer relevant information necessary to make the reports described in subsection (b). (b) Reports (1) For plan years beginning on or after the effective date, in the case of any contract between a group health plan or a health insurance issuer offering group health insurance coverage offered in connection with such a plan and an entity providing pharmacy benefit management services on behalf of such plan or issuer, including an extension or renewal of such a contract, entered into on or after the effective date, the entity providing pharmacy benefit management services on behalf of such a group health plan or health insurance issuer, not less frequently than every 6 months (or, at the request of a group health plan, not less frequently than quarterly, and under the same conditions, terms, and cost of the semiannual report under this subsection), shall submit to the group health plan a report in accordance with this section. Each such report shall be made available to such group health plan in plain language, in a machine-readable format, and as the Secretary may determine, other formats. Each such report shall include the information described in paragraph (2).

(2) For purposes of paragraph (1), the information described in this paragraph is, with respect to drugs covered by a group health plan or group health insurance coverage offered by a health insurance issuer in connection with a group health plan during each reporting period— (A) in the case of a group health plan that is offered by a specified large employer or that is a specified large plan, and is not offered as health insurance coverage, or in the case of health insurance coverage for which the election under paragraph (3) is made for the applicable reporting period— (i) a list of drugs for which a claim was filed and, with respect to each such drug on such list— (I) the contracted compensation paid by the group health plan or health insurance issuer for each covered drug (identified by the National Drug Code) to the entity providing pharmacy benefit management services or other applicable entity on behalf of the group health plan or health insurance issuer; (II) the contracted compensation paid to the pharmacy, by any entity providing pharmacy benefit management services or other applicable entity on behalf of the group health plan or health insurance issuer, for each covered drug (identified by the National Drug Code); (III) for each such claim, the difference between the amount paid under subclause (I) and the amount paid under subclause (II); (IV) the proprietary name, established name or proper name, and the National Drug Code; (V) for each claim for the drug (including original prescriptions and refills) and for each dosage unit of the drug for which a claim was filed, the type of dispensing channel used to furnish the drug, including retail, mail order, or specialty pharmacy; (VI) with respect to each drug dispensed, for each type of dispensing channel (including retail, mail order, or specialty pharmacy)— (VII) the net price per course of treatment or single fill, such as a 30-day supply or 90-day supply to the plan or coverage after rebates, fees, alternative discounts, or other remuneration received from applicable entities; (VIII) the total amount of out-of-pocket spending by participants and beneficiaries on such drug, including spending through copayments, coinsurance, and deductibles, but not including any amounts spent by participants and beneficiaries on drugs not covered under the plan or coverage, or for which no claim is submitted under the plan or coverage; (IX) the total net spending on the drug; (X) the total amount received, or expected to be received, by the plan or issuer from any applicable entity in rebates, fees, alternative discounts, or other remuneration; (XI) the total amount received, or expected to be received, by the entity providing pharmacy benefit management services, from applicable entities, in rebates, fees, alternative discounts, or other remuneration from such entities— (XII) to the extent feasible, information on the total amount of remuneration for such drug, including copayment assistance dollars paid, copayment cards applied, or other discounts provided by each drug manufacturer (or entity administering copayment assistance on behalf of such drug manufacturer), to the participants and beneficiaries enrolled in such plan or coverage; (ii) a list of each therapeutic class (as defined by the Secretary) for which a claim was filed under the group health plan or health insurance coverage during the reporting period, and, with respect to each such therapeutic class— (I) the total gross spending on drugs in such class before rebates, price concessions, alternative discounts, or other remuneration from applicable entities; (II) the net spending in such class after such rebates, price concessions, alternative discounts, or other remuneration from applicable entities; (III) the total amount received, or expected to be received, by the entity providing pharmacy benefit management services, from applicable entities, in rebates, fees, alternative discounts, or other remuneration from such entities— (IV) the average net spending per 30-day supply and per 90-day supply by the plan or by the issuer with respect to such coverage and its participants and beneficiaries, among all drugs within the therapeutic class for which a claim was filed during the reporting period; (V) the number of participants and beneficiaries who filled a prescription for a drug in such class, including the National Drug Code for each such drug; (VI) if applicable, a description of the formulary tiers and utilization mechanisms (such as prior authorization or step therapy) employed for drugs in that class; and (VII) the total out-of-pocket spending under the plan or coverage by participants and beneficiaries, including spending through copayments, coinsurance, and deductibles, but not including any amounts spent by participants and beneficiaries on drugs not covered under the plan or coverage or for which no claim is submitted under the plan or coverage; (iii) with respect to any drug for which gross spending under the group health plan or health insurance coverage exceeded $10,000 during the reporting period or, in the case that gross spending under the group health plan or coverage exceeded $10,000 during the reporting period with respect to fewer than 50 drugs, with respect to the 50 prescription drugs with the highest spending during the reporting period— (I) a list of all other drugs in the same therapeutic class as such drug; (II) if applicable, the rationale for the formulary placement of such drug in that therapeutic category or class, selected from a list of standard rationales established by the Secretary, in consultation with stakeholders; and (III) any change in formulary placement compared to the prior plan year; and (iv) in the case that such plan or issuer (or an entity providing pharmacy benefit management services on behalf of such plan or issuer) has an affiliated pharmacy or pharmacy under common ownership, including mandatory mail and specialty home delivery programs, retail and mail auto-refill programs, and cost sharing assistance incentives funded by an entity providing pharmacy benefit services— (I) an explanation of any benefit design parameters that encourage or require participants and beneficiaries in the plan or coverage to fill prescriptions at mail order, specialty, or retail pharmacies; (II) the percentage of total prescriptions dispensed by such pharmacies to participants or beneficiaries in such plan or coverage; and (III) a list of all drugs dispensed by such pharmacies to participants or beneficiaries enrolled in such plan or coverage, and, with respect to each drug dispensed— (B) with respect to any group health plan, including group health insurance coverage offered in connection with such a plan, regardless of whether the plan or coverage is offered by a specified large employer or whether it is a specified large plan— (i) a summary document for the group health plan that includes such information described in clauses (i) through (iv) of subparagraph (A), as specified by the Secretary through guidance, program instruction, or otherwise (with no requirement of notice and comment rulemaking), that the Secretary determines useful to group health plans for purposes of selecting pharmacy benefit management services, such as an estimated net price to group health plan and participant or beneficiary, a cost per claim, the fee structure or reimbursement model, and estimated cost per participant or beneficiary; (ii) a summary document for plans and issuers to provide to participants and beneficiaries, which shall be made available to participants or beneficiaries upon request to their group health plan (including in the case of group health insurance coverage offered in connection with such a plan), that— (I) contains such information described in clauses (iii), (iv), (v), and (vi), as applicable, as specified by the Secretary through guidance, program instruction, or otherwise (with no requirement of notice and comment rulemaking) that the Secretary determines useful to participants or beneficiaries in better understanding the plan or coverage or benefits under such plan or coverage; (II) contains only aggregate information; and (III) states that participants and beneficiaries may request specific, claims-level information required to be furnished under subsection (c) from the group health plan or health insurance issuer; and (iii) with respect to drugs covered by such plan or coverage during such reporting period— (I) the total net spending by the plan or coverage for all such drugs; (II) the total amount received, or expected to be received, by the plan or issuer from any applicable entity in rebates, fees, alternative discounts, or other remuneration; and (III) to the extent feasible, information on the total amount of remuneration for such drugs, including copayment assistance dollars paid, copayment cards applied, or other discounts provided by each drug manufacturer (or entity administering copayment assistance on behalf of such drug manufacturer) to participants and beneficiaries; (iv) amounts paid directly or indirectly in rebates, fees, or any other type of compensation (as defined in section 408(b)(2)(B)(ii)(dd)(AA) of the Employee Retirement Income Security Act) to brokerage firms, brokers, consultants, advisors, or any other individual or firm, for— (I) the referral of the group health plan's or health insurance issuer's business to an entity providing pharmacy benefit management services, including the identity of the recipient of such amounts; (II) consideration of the entity providing pharmacy benefit management services by the group health plan or health insurance issuer; or (III) the retention of the entity by the group health plan or health insurance issuer; (v) an explanation of any benefit design parameters that encourage or require participants and beneficiaries in such plan or coverage to fill prescriptions at mail order, specialty, or retail pharmacies that are affiliated with or under common ownership with the entity providing pharmacy benefit management services under such plan or coverage, including mandatory mail and specialty home delivery programs, retail and mail auto-refill programs, and cost-sharing assistance incentives directly or indirectly funded by such entity; and (vi) total gross spending on all drugs under the plan or coverage during the reporting period.

(3) In the case of group health insurance coverage offered in connection with a group health plan that is offered by a specified large employer or is a specified large plan, such group health plan may, on an annual basis, for plan years beginning on or after the date that is 30 months after the date of enactment of this section, elect to require an entity providing pharmacy benefit management services on behalf of the health insurance issuer to submit to such group health plan a report that includes all of the information described in paragraph (2)(A), in addition to the information described in paragraph (2)(B).

(4) Privacy requirements (A) An entity providing pharmacy benefit management services on behalf of a group health plan or a health insurance issuer offering group health insurance coverage shall report information under paragraph (1) in a manner consistent with the privacy regulations promulgated under section 13402(a) of the Health Information Technology for Economic and Clinical Health Act and consistent with the privacy regulations promulgated under the Health Insurance Portability and Accountability Act of 1996 in part 160 and subparts A and E of part 164 of title 45, Code of Federal Regulations (or successor regulations) (referred to in this paragraph as the ) and shall restrict the use and disclosure of such information according to such privacy regulations and such HIPAA privacy regulations. "HIPAA privacy regulations" (B) Additional requirements (i) An entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer offering group health insurance coverage that submits a report under paragraph (1) shall ensure that such report contains only summary health information, as defined in section 164.504(a) of title 45, Code of Federal Regulations (or successor regulations). (ii) In carrying out this subsection, a group health plan shall comply with section 164.504(f) of title 45, Code of Federal Regulations (or a successor regulation), and a plan sponsor shall act in accordance with the terms of the agreement described in such section. (C) Rule of construction (i) Nothing in this section shall be construed to modify the requirements for the creation, receipt, maintenance, or transmission of protected health information under the HIPAA privacy regulations. (ii) Nothing in this section shall be construed to affect the application of any Federal or State privacy or civil rights law, including the HIPAA privacy regulations, the Genetic Information Nondiscrimination Act of 2008 (Public Law 110–233; 42 U.S.C. 12101 et seq.; 29 U.S.C. 794; 42 U.S.C. 18116; 42 U.S.C. 2000d; 42 U.S.C. 2000e) (including the amendments made by such Act), the Americans with Disabilities Act of 1990 (), section 504 of the Rehabilitation Act of 1973 (), section 1557 of the Patient Protection and Affordable Care Act (), title VI of the Civil Rights Act of 1964 (), and title VII of the Civil Rights Act of 1964 (). (D) Each plan year, group health plans, including with respect to group health insurance coverage offered in connection with a group health plan, shall provide to each participant or beneficiary written notice informing the participant or beneficiary of the requirement for entities providing pharmacy benefit management services on behalf of the group health plan or health insurance issuer offering group health insurance coverage to submit reports to group health plans under paragraph (1), as applicable, which may include incorporating such notification in plan documents provided to the participant or beneficiary, or providing individual notification. (E) A group health plan receiving a report under paragraph (1) may disclose such information only to the entity from which the report was received or to that entity’s business associates as defined in section 160.103 of title 45, Code of Federal Regulations (or successor regulations) or as permitted by the HIPAA privacy regulations. (F) Nothing in this section shall prevent an entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer offering group health insurance coverage, from placing reasonable restrictions on the public disclosure of the information contained in a report described in paragraph (1), except that such plan, issuer, or entity may not— (i) restrict disclosure of such report to the Department of Health and Human Services, the Department of Labor, or the Department of the Treasury; or (ii) prevent disclosure for the purposes of subsection (c), or any other public disclosure requirement under this section. (G) The Secretary shall define through rulemaking a limited form of the report under paragraph (1) required with respect to any group health plan established by a plan sponsor that is, or is affiliated with, a drug manufacturer, drug wholesaler, or other direct participant in the drug supply chain, in order to prevent anti-competitive behavior.

(5) Standard format and regulations (A) Not later than 18 months after the date of enactment of this section, the Secretary shall specify through rulemaking a standard format for entities providing pharmacy benefit management services on behalf of group health plans and health insurance issuers offering group health insurance coverage, to submit reports required under paragraph (1). (B) Not later than 18 months after the date of enactment of this section, the Secretary shall, through rulemaking, promulgate any other final regulations necessary to implement the requirements of this section. In promulgating such regulations, the Secretary shall, to the extent practicable, align the reporting requirements under this section with the reporting requirements under section 2799A–10. (c) Requirement To provide information to participants or beneficiaries A group health plan, including with respect to group health insurance coverage offered in connection with a group health plan, upon request of a participant or beneficiary, shall provide to such participant or beneficiary— (1) the summary document described in subsection (b)(2)(B)(ii); and

(2) the information described in subsection (b)(2)(A)(i)(III) with respect to a claim made by or on behalf of such participant or beneficiary. (d) Enforcement (1) The Secretary shall enforce this section. The enforcement authority under this subsection shall apply only with respect to group health plans (including group health insurance coverage offered in connection with such a plan) to which the requirements of subparts I and II of part A and part D apply in accordance with section 2722, and with respect to entities providing pharmacy benefit management services on behalf of such plans and applicable entities providing services on behalf of such plans.

(2) A group health plan, a health insurance issuer offering group health insurance coverage, an entity providing pharmacy benefit management services on behalf of such a plan or issuer, or an applicable entity providing services on behalf of such a plan or issuer that violates subsection (a); an entity providing pharmacy benefit management services on behalf of such a plan or issuer that fails to provide the information required under subsection (b); or a group health plan that fails to provide the information required under subsection (c), shall be subject to a civil monetary penalty in the amount of $10,000 for each day during which such violation continues or such information is not disclosed or reported.

(3) A health insurance issuer, an entity providing pharmacy benefit management services, or a third party administrator providing services on behalf of such issuer offered by a health insurance issuer that knowingly provides false information under this section shall be subject to a civil monetary penalty in an amount not to exceed $100,000 for each item of false information. Such civil monetary penalty shall be in addition to other penalties as may be prescribed by law.

(4) The provisions of section 1128A of the Social Security Act, other than subsections (a) and (b) and the first sentence of subsection (c)(1) of such section shall apply to civil monetary penalties under this subsection in the same manner as such provisions apply to a penalty or proceeding under such section.

(5) The Secretary may waive penalties under paragraph (2), or extend the period of time for compliance with a requirement of this section, for an entity in violation of this section that has made a good-faith effort to comply with the requirements in this section. (e) Rule of construction Nothing in this section shall be construed to permit a health insurance issuer, group health plan, entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer, or other entity to restrict disclosure to, or otherwise limit the access of, the Secretary to a report described in subsection (b)(1) or information related to compliance with subsections (a), (b), (c), or (d) by such issuer, plan, or entity. (f) Definitions In this section: (1) The term applicable entity means— (A) an applicable group purchasing organization, drug manufacturer, distributor, wholesaler, rebate aggregator (or other purchasing entity designed to aggregate rebates), or associated third party; (B) any subsidiary, parent, affiliate, or subcontractor of a group health plan, health insurance issuer, entity that provides pharmacy benefit management services on behalf of such a plan or issuer, or any entity described in subparagraph (A); or (C) such other entity as the Secretary may specify through rulemaking.

(2) The term applicable group purchasing organization means a group purchasing organization that is affiliated with or under common ownership with an entity providing pharmacy benefit management services.

(3) The term contracted compensation means the sum of any ingredient cost and dispensing fee for a drug (inclusive of the out-of-pocket costs to the participant or beneficiary), or another analogous compensation structure that the Secretary may specify through regulations.

(4) The term , with respect to prescription drug benefits under a group health plan or health insurance coverage, means the amount spent by a group health plan or health insurance issuer on prescription drug benefits, calculated before the application of rebates, fees, alternative discounts, or other remuneration. gross spending

(5) The term , with respect to prescription drug benefits under a group health plan or health insurance coverage, means the amount spent by a group health plan or health insurance issuer on prescription drug benefits, calculated after the application of rebates, fees, alternative discounts, or other remuneration. net spending

(6) The term plan sponsor has the meaning given such term in section 3(16)(B) of the Employee Retirement Income Security Act of 1974.

(7) The term remuneration has the meaning given such term by the Secretary through rulemaking, which shall be reevaluated by the Secretary every 5 years.

(8) The term specified large employer means, in connection with a group health plan (including group health insurance coverage offered in connection with such a plan) established or maintained by a single employer, with respect to a calendar year or a plan year, as applicable, an employer who employed an average of at least 100 employees on business days during the preceding calendar year or plan year and who employs at least 1 employee on the first day of the calendar year or plan year.

(9) The term specified large plan means a group health plan (including group health insurance coverage offered in connection with such a plan) established or maintained by a plan sponsor described in clause (ii) or (iii) of section 3(16)(B) of the Employee Retirement Income Security Act of 1974 that had an average of at least 100 participants on business days during the preceding calendar year or plan year, as applicable.

(10) The term wholesale acquisition cost has the meaning given such term in section 1847A(c)(6)(B) of the Social Security Act.; and

SEC. 726. Oversight of entities that provide pharmacy benefit management services (a) In general For plan years beginning on or after the date that is 30 months after the date of enactment of this section (referred to in this subsection and subsection (b) as the ), a group health plan or a health insurance issuer offering group health insurance coverage, or an entity providing pharmacy benefit management services on behalf of such a plan or issuer, shall not enter into a contract, including an extension or renewal of a contract, entered into on or after the effective date, with an applicable entity unless such applicable entity agrees to— "effective date" (1) not limit or delay the disclosure of information to the group health plan (including such a plan offered through a health insurance issuer) in such a manner that prevents an entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer offering group health insurance coverage from making the reports described in subsection (b); and

(2) provide the entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer relevant information necessary to make the reports described in subsection (b). (b) Reports (1) For plan years beginning on or after the effective date, in the case of any contract between a group health plan or a health insurance issuer offering group health insurance coverage offered in connection with such a plan and an entity providing pharmacy benefit management services on behalf of such plan or issuer, including an extension or renewal of such a contract, entered into on or after the effective date, the entity providing pharmacy benefit management services on behalf of such a group health plan or health insurance issuer, not less frequently than every 6 months (or, at the request of a group health plan, not less frequently than quarterly, and under the same conditions, terms, and cost of the semiannual report under this subsection), shall submit to the group health plan a report in accordance with this section. Each such report shall be made available to such group health plan in plain language, in a machine-readable format, and as the Secretary may determine, other formats. Each such report shall include the information described in paragraph (2).

(2) For purposes of paragraph (1), the information described in this paragraph is, with respect to drugs covered by a group health plan or group health insurance coverage offered by a health insurance issuer in connection with a group health plan during each reporting period— (A) in the case of a group health plan that is offered by a specified large employer or that is a specified large plan, and is not offered as health insurance coverage, or in the case of health insurance coverage for which the election under paragraph (3) is made for the applicable reporting period— (i) a list of drugs for which a claim was filed and, with respect to each such drug on such list— (I) the contracted compensation paid by the group health plan or health insurance issuer for each covered drug (identified by the National Drug Code) to the entity providing pharmacy benefit management services or other applicable entity on behalf of the group health plan or health insurance issuer; (II) the contracted compensation paid to the pharmacy, by any entity providing pharmacy benefit management services or other applicable entity on behalf of the group health plan or health insurance issuer, for each covered drug (identified by the National Drug Code); (III) for each such claim, the difference between the amount paid under subclause (I) and the amount paid under subclause (II); (IV) the proprietary name, established name or proper name, and National Drug Code; (V) for each claim for the drug (including original prescriptions and refills) and for each dosage unit of the drug for which a claim was filed, the type of dispensing channel used to furnish the drug, including retail, mail order, or specialty pharmacy; (VI) with respect to each drug dispensed, for each type of dispensing channel (including retail, mail order, or specialty pharmacy)— (VII) the net price per course of treatment or single fill, such as a 30-day supply or 90-day supply to the plan or coverage after rebates, fees, alternative discounts, or other remuneration received from applicable entities; (VIII) the total amount of out-of-pocket spending by participants and beneficiaries on such drug, including spending through copayments, coinsurance, and deductibles, but not including any amounts spent by participants and beneficiaries on drugs not covered under the plan or coverage, or for which no claim is submitted under the plan or coverage; (IX) the total net spending on the drug; (X) the total amount received, or expected to be received, by the plan or issuer from any applicable entity in rebates, fees, alternative discounts, or other remuneration; (XI) the total amount received, or expected to be received, by the entity providing pharmacy benefit management services, from applicable entities, in rebates, fees, alternative discounts, or other remuneration from such entities— (XII) to the extent feasible, information on the total amount of remuneration for such drug, including copayment assistance dollars paid, copayment cards applied, or other discounts provided by each drug manufacturer (or entity administering copayment assistance on behalf of such drug manufacturer), to the participants and beneficiaries enrolled in such plan or coverage; (ii) a list of each therapeutic class (as defined by the Secretary) for which a claim was filed under the group health plan or health insurance coverage during the reporting period, and, with respect to each such therapeutic class— (I) the total gross spending on drugs in such class before rebates, price concessions, alternative discounts, or other remuneration from applicable entities; (II) the net spending in such class after such rebates, price concessions, alternative discounts, or other remuneration from applicable entities; (III) the total amount received, or expected to be received, by the entity providing pharmacy benefit management services, from applicable entities, in rebates, fees, alternative discounts, or other remuneration from such entities— (IV) the average net spending per 30-day supply and per 90-day supply by the plan or by the issuer with respect to such coverage and its participants and beneficiaries, among all drugs within the therapeutic class for which a claim was filed during the reporting period; (V) the number of participants and beneficiaries who filled a prescription for a drug in such class, including the National Drug Code for each such drug; (VI) if applicable, a description of the formulary tiers and utilization mechanisms (such as prior authorization or step therapy) employed for drugs in that class; and (VII) the total out-of-pocket spending under the plan or coverage by participants and beneficiaries, including spending through copayments, coinsurance, and deductibles, but not including any amounts spent by participants and beneficiaries on drugs not covered under the plan or coverage or for which no claim is submitted under the plan or coverage; (iii) with respect to any drug for which gross spending under the group health plan or health insurance coverage exceeded $10,000 during the reporting period or, in the case that gross spending under the group health plan or coverage exceeded $10,000 during the reporting period with respect to fewer than 50 drugs, with respect to the 50 prescription drugs with the highest spending during the reporting period— (I) a list of all other drugs in the same therapeutic class as such drug; (II) if applicable, the rationale for the formulary placement of such drug in that therapeutic category or class, selected from a list of standard rationales established by the Secretary, in consultation with stakeholders; and (III) any change in formulary placement compared to the prior plan year; and (iv) in the case that such plan or issuer (or an entity providing pharmacy benefit management services on behalf of such plan or issuer) has an affiliated pharmacy or pharmacy under common ownership, including mandatory mail and specialty home delivery programs, retail and mail auto-refill programs, and cost sharing assistance incentives funded by an entity providing pharmacy benefit services— (I) an explanation of any benefit design parameters that encourage or require participants and beneficiaries in the plan or coverage to fill prescriptions at mail order, specialty, or retail pharmacies; (II) the percentage of total prescriptions dispensed by such pharmacies to participants or beneficiaries in such plan or coverage; and (III) a list of all drugs dispensed by such pharmacies to participants or beneficiaries enrolled in such plan or coverage, and, with respect to each drug dispensed— (B) with respect to any group health plan, including group health insurance coverage offered in connection with such a plan, regardless of whether the plan or coverage is offered by a specified large employer or whether it is a specified large plan— (i) a summary document for the group health plan that includes such information described in clauses (i) through (iv) of subparagraph (A), as specified by the Secretary through guidance, program instruction, or otherwise (with no requirement of notice and comment rulemaking), that the Secretary determines useful to group health plans for purposes of selecting pharmacy benefit management services, such as an estimated net price to group health plan and participant or beneficiary, a cost per claim, the fee structure or reimbursement model, and estimated cost per participant or beneficiary; (ii) a summary document for plans and issuers to provide to participants and beneficiaries, which shall be made available to participants or beneficiaries upon request to their group health plan (including in the case of group health insurance coverage offered in connection with such a plan), that— (I) contains such information described in clauses (iii), (iv), (v), and (vi), as applicable, as specified by the Secretary through guidance, program instruction, or otherwise (with no requirement of notice and comment rulemaking) that the Secretary determines useful to participants or beneficiaries in better understanding the plan or coverage or benefits under such plan or coverage; (II) contains only aggregate information; and (III) states that participants and beneficiaries may request specific, claims-level information required to be furnished under subsection (c) from the group health plan or health insurance issuer; and (iii) with respect to drugs covered by such plan or coverage during such reporting period— (I) the total net spending by the plan or coverage for all such drugs; (II) the total amount received, or expected to be received, by the plan or issuer from any applicable entity in rebates, fees, alternative discounts, or other remuneration; and (III) to the extent feasible, information on the total amount of remuneration for such drugs, including copayment assistance dollars paid, copayment cards applied, or other discounts provided by each drug manufacturer (or entity administering copayment assistance on behalf of such drug manufacturer) to participants and beneficiaries; (iv) amounts paid directly or indirectly in rebates, fees, or any other type of compensation (as defined in section 408(b)(2)(B)(ii)(dd)(AA)) to brokerage firms, brokers, consultants, advisors, or any other individual or firm, for— (I) the referral of the group health plan's or health insurance issuer's business to an entity providing pharmacy benefit management services, including the identity of the recipient of such amounts; (II) consideration of the entity providing pharmacy benefit management services by the group health plan or health insurance issuer; or (III) the retention of the entity by the group health plan or health insurance issuer; (v) an explanation of any benefit design parameters that encourage or require participants and beneficiaries in such plan or coverage to fill prescriptions at mail order, specialty, or retail pharmacies that are affiliated with or under common ownership with the entity providing pharmacy benefit management services under such plan or coverage, including mandatory mail and specialty home delivery programs, retail and mail auto-refill programs, and cost-sharing assistance incentives directly or indirectly funded by such entity; and (vi) total gross spending on all drugs under the plan or coverage during the reporting period.

(3) In the case of group health insurance coverage offered in connection with a group health plan that is offered by a specified large employer or is a specified large plan, such group health plan may, on an annual basis, for plan years beginning on or after the date that is 30 months after the date of enactment of this section, elect to require an entity providing pharmacy benefit management services on behalf of the health insurance issuer to submit to such group health plan a report that includes all of the information described in paragraph (2)(A), in addition to the information described in paragraph (2)(B).

(4) Privacy requirements (A) An entity providing pharmacy benefit management services on behalf of a group health plan or a health insurance issuer offering group health insurance coverage shall report information under paragraph (1) in a manner consistent with the privacy regulations promulgated under section 13402(a) of the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. 17932(a)) and consistent with the privacy regulations promulgated under the Health Insurance Portability and Accountability Act of 1996 in part 160 and subparts A and E of part 164 of title 45, Code of Federal Regulations (or successor regulations) (referred to in this paragraph as the ) and shall restrict the use and disclosure of such information according to such privacy regulations and such HIPAA privacy regulations. "HIPAA privacy regulations" (B) Additional requirements (i) An entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer offering group health insurance coverage that submits a report under paragraph (1) shall ensure that such report contains only summary health information, as defined in section 164.504(a) of title 45, Code of Federal Regulations (or successor regulations). (ii) In carrying out this subsection, a group health plan shall comply with section 164.504(f) of title 45, Code of Federal Regulations (or a successor regulation), and a plan sponsor shall act in accordance with the terms of the agreement described in such section. (C) Rule of construction (i) Nothing in this section shall be construed to modify the requirements for the creation, receipt, maintenance, or transmission of protected health information under the HIPAA privacy regulations. (ii) Nothing in this section shall be construed to affect the application of any Federal or State privacy or civil rights law, including the HIPAA privacy regulations, the Genetic Information Nondiscrimination Act of 2008 (Public Law 110–233; 42 U.S.C. 12101 et seq.; 29 U.S.C. 794; 42 U.S.C. 18116; 42 U.S.C. 2000d; 42 U.S.C. 2000e) (including the amendments made by such Act), the Americans with Disabilities Act of 1990 (), section 504 of the Rehabilitation Act of 1973 (), section 1557 of the Patient Protection and Affordable Care Act (), title VI of the Civil Rights Act of 1964 (), and title VII of the Civil Rights Act of 1964 (). (D) Each plan year, group health plans, including with respect to group health insurance coverage offered in connection with a group health plan, shall provide to each participant or beneficiary written notice informing the participant or beneficiary of the requirement for entities providing pharmacy benefit management services on behalf of the group health plan or health insurance issuer offering group health insurance coverage to submit reports to group health plans under paragraph (1), as applicable, which may include incorporating such notification in plan documents provided to the participant or beneficiary, or providing individual notification. (E) A group health plan receiving a report under paragraph (1) may disclose such information only to the entity from which the report was received or to that entity’s business associates as defined in section 160.103 of title 45, Code of Federal Regulations (or successor regulations) or as permitted by the HIPAA privacy regulations. (F) Nothing in this section shall prevent an entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer offering group health insurance coverage, from placing reasonable restrictions on the public disclosure of the information contained in a report described in paragraph (1), except that such plan, issuer, or entity may not— (i) restrict disclosure of such report to the Department of Health and Human Services, the Department of Labor, or the Department of the Treasury; or (ii) prevent disclosure for the purposes of subsection (c), or any other public disclosure requirement under this section. (G) The Secretary shall define through rulemaking a limited form of the report under paragraph (1) required with respect to any group health plan established by a plan sponsor that is, or is affiliated with, a drug manufacturer, drug wholesaler, or other direct participant in the drug supply chain, in order to prevent anti-competitive behavior.

(5) Standard format and regulations (A) Not later than 18 months after the date of enactment of this section, the Secretary shall specify through rulemaking a standard format for entities providing pharmacy benefit management services on behalf of group health plans and health insurance issuers offering group health insurance coverage, to submit reports required under paragraph (1). (B) Not later than 18 months after the date of enactment of this section, the Secretary shall, through rulemaking, promulgate any other final regulations necessary to implement the requirements of this section. In promulgating such regulations, the Secretary shall, to the extent practicable, align the reporting requirements under this section with the reporting requirements under section 725. (c) Requirement To provide information to participants or beneficiaries A group health plan, including with respect to group health insurance coverage offered in connection with a group health plan, upon request of a participant or beneficiary, shall provide to such participant or beneficiary— (1) the summary document described in subsection (b)(2)(B)(ii); and

(2) the information described in subsection (b)(2)(A)(i)(III) with respect to a claim made by or on behalf of such participant or beneficiary. (d) Rule of construction Nothing in this section shall be construed to permit a health insurance issuer, group health plan, entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer, or other entity to restrict disclosure to, or otherwise limit the access of, the Secretary to a report described in subsection (b)(1) or information related to compliance with subsections (a), (b), or (c) of this section or section 502(c)(13) by such issuer, plan, or entity. (e) Definitions In this section: (1) The term applicable entity means— (A) an applicable group purchasing organization, drug manufacturer, distributor, wholesaler, rebate aggregator (or other purchasing entity designed to aggregate rebates), or associated third party; (B) any subsidiary, parent, affiliate, or subcontractor of a group health plan, health insurance issuer, entity that provides pharmacy benefit management services on behalf of such a plan or issuer, or any entity described in subparagraph (A); or (C) such other entity as the Secretary may specify through rulemaking.

(2) The term applicable group purchasing organization means a group purchasing organization that is affiliated with or under common ownership with an entity providing pharmacy benefit management services.

(3) The term contracted compensation means the sum of any ingredient cost and dispensing fee for a drug (inclusive of the out-of-pocket costs to the participant or beneficiary), or another analogous compensation structure that the Secretary may specify through regulations.

(4) The term , with respect to prescription drug benefits under a group health plan or health insurance coverage, means the amount spent by a group health plan or health insurance issuer on prescription drug benefits, calculated before the application of rebates, fees, alternative discounts, or other remuneration. gross spending

(5) The term , with respect to prescription drug benefits under a group health plan or health insurance coverage, means the amount spent by a group health plan or health insurance issuer on prescription drug benefits, calculated after the application of rebates, fees, alternative discounts, or other remuneration. net spending

(6) The term plan sponsor has the meaning given such term in section 3(16)(B).

(7) The term remuneration has the meaning given such term by the Secretary through rulemaking, which shall be reevaluated by the Secretary every 5 years.

(8) The term specified large employer means, in connection with a group health plan (including group health insurance coverage offered in connection with such a plan) established or maintained by a single employer, with respect to a calendar year or a plan year, as applicable, an employer who employed an average of at least 100 employees on business days during the preceding calendar year or plan year and who employs at least 1 employee on the first day of the calendar year or plan year.

(9) The term specified large plan means a group health plan (including group health insurance coverage offered in connection with such a plan) established or maintained by a plan sponsor described in clause (ii) or (iii) of section 3(16)(B) that had an average of at least 100 participants on business days during the preceding calendar year or plan year, as applicable.

(10) The term wholesale acquisition cost has the meaning given such term in section 1847A(c)(6)(B) of the Social Security Act (42 U.S.C. 1395w–3a(c)(6)(B)).; (B) in section 502 (29 U.S.C. 1132)— (i) in subsection (a)(6), by striking "or (9)" and inserting "(9), or (13)" ; (ii) in subsection (b)(3), by striking "under subsection (c)(9)" and inserting "under paragraphs (9) and (13) of subsection (c)" ; and (iii) in subsection (c), by adding at the end the following: (C) in section 732(a) (29 U.S.C. 1191a(a)), by striking "section 711" and inserting "sections 711 and 726" .

SEC. 9826. Oversight of entities that provide pharmacy benefit management services (a) In general For plan years beginning on or after the date that is 30 months after the date of enactment of this section (referred to in this subsection and subsection (b) as the ), a group health plan, or an entity providing pharmacy benefit management services on behalf of such a plan, shall not enter into a contract, including an extension or renewal of a contract, entered into on or after the effective date, with an applicable entity unless such applicable entity agrees to— "effective date" (1) not limit or delay the disclosure of information to the group health plan in such a manner that prevents an entity providing pharmacy benefit management services on behalf of a group health plan from making the reports described in subsection (b); and

(2) provide the entity providing pharmacy benefit management services on behalf of a group health plan relevant information necessary to make the reports described in subsection (b). (b) Reports (1) For plan years beginning on or after the effective date, in the case of any contract between a group health plan and an entity providing pharmacy benefit management services on behalf of such plan, including an extension or renewal of such a contract, entered into on or after the effective date, the entity providing pharmacy benefit management services on behalf of such a group health plan, not less frequently than every 6 months (or, at the request of a group health plan, not less frequently than quarterly, and under the same conditions, terms, and cost of the semiannual report under this subsection), shall submit to the group health plan a report in accordance with this section. Each such report shall be made available to such group health plan in plain language, in a machine-readable format, and as the Secretary may determine, other formats. Each such report shall include the information described in paragraph (2).

(2) For purposes of paragraph (1), the information described in this paragraph is, with respect to drugs covered by a group health plan during each reporting period— (A) in the case of a group health plan that is offered by a specified large employer or that is a specified large plan, and is not offered as health insurance coverage, or in the case of health insurance coverage for which the election under paragraph (3) is made for the applicable reporting period— (i) a list of drugs for which a claim was filed and, with respect to each such drug on such list— (I) the contracted compensation paid by the group health plan for each covered drug (identified by the National Drug Code) to the entity providing pharmacy benefit management services or other applicable entity on behalf of the group health plan; (II) the contracted compensation paid to the pharmacy, by any entity providing pharmacy benefit management services or other applicable entity on behalf of the group health plan, for each covered drug (identified by the National Drug Code); (III) for each such claim, the difference between the amount paid under subclause (I) and the amount paid under subclause (II); (IV) the proprietary name, established name or proper name, and National Drug Code; (V) for each claim for the drug (including original prescriptions and refills) and for each dosage unit of the drug for which a claim was filed, the type of dispensing channel used to furnish the drug, including retail, mail order, or specialty pharmacy; (VI) with respect to each drug dispensed, for each type of dispensing channel (including retail, mail order, or specialty pharmacy)— (VII) the net price per course of treatment or single fill, such as a 30-day supply or 90-day supply to the plan after rebates, fees, alternative discounts, or other remuneration received from applicable entities; (VIII) the total amount of out-of-pocket spending by participants and beneficiaries on such drug, including spending through copayments, coinsurance, and deductibles, but not including any amounts spent by participants and beneficiaries on drugs not covered under the plan, or for which no claim is submitted under the plan; (IX) the total net spending on the drug; (X) the total amount received, or expected to be received, by the plan from any applicable entity in rebates, fees, alternative discounts, or other remuneration; (XI) the total amount received, or expected to be received, by the entity providing pharmacy benefit management services, from applicable entities, in rebates, fees, alternative discounts, or other remuneration from such entities— (XII) to the extent feasible, information on the total amount of remuneration for such drug, including copayment assistance dollars paid, copayment cards applied, or other discounts provided by each drug manufacturer (or entity administering copayment assistance on behalf of such drug manufacturer), to the participants and beneficiaries enrolled in such plan; (ii) a list of each therapeutic class (as defined by the Secretary) for which a claim was filed under the group health plan during the reporting period, and, with respect to each such therapeutic class— (I) the total gross spending on drugs in such class before rebates, price concessions, alternative discounts, or other remuneration from applicable entities; (II) the net spending in such class after such rebates, price concessions, alternative discounts, or other remuneration from applicable entities; (III) the total amount received, or expected to be received, by the entity providing pharmacy benefit management services, from applicable entities, in rebates, fees, alternative discounts, or other remuneration from such entities— (IV) the average net spending per 30-day supply and per 90-day supply by the plan and its participants and beneficiaries, among all drugs within the therapeutic class for which a claim was filed during the reporting period; (V) the number of participants and beneficiaries who filled a prescription for a drug in such class, including the National Drug Code for each such drug; (VI) if applicable, a description of the formulary tiers and utilization mechanisms (such as prior authorization or step therapy) employed for drugs in that class; and (VII) the total out-of-pocket spending under the plan by participants and beneficiaries, including spending through copayments, coinsurance, and deductibles, but not including any amounts spent by participants and beneficiaries on drugs not covered under the plan or for which no claim is submitted under the plan; (iii) with respect to any drug for which gross spending under the group health plan exceeded $10,000 during the reporting period or, in the case that gross spending under the group health plan exceeded $10,000 during the reporting period with respect to fewer than 50 drugs, with respect to the 50 prescription drugs with the highest spending during the reporting period— (I) a list of all other drugs in the same therapeutic class as such drug; (II) if applicable, the rationale for the formulary placement of such drug in that therapeutic category or class, selected from a list of standard rationales established by the Secretary, in consultation with stakeholders; and (III) any change in formulary placement compared to the prior plan year; and (iv) in the case that such plan (or an entity providing pharmacy benefit management services on behalf of such plan) has an affiliated pharmacy or pharmacy under common ownership, including mandatory mail and specialty home delivery programs, retail and mail auto-refill programs, and cost sharing assistance incentives funded by an entity providing pharmacy benefit services— (I) an explanation of any benefit design parameters that encourage or require participants and beneficiaries in the plan to fill prescriptions at mail order, specialty, or retail pharmacies; (II) the percentage of total prescriptions dispensed by such pharmacies to participants or beneficiaries in such plan; and (III) a list of all drugs dispensed by such pharmacies to participants or beneficiaries enrolled in such plan, and, with respect to each drug dispensed— (B) with respect to any group health plan, regardless of whether the plan is offered by a specified large employer or whether it is a specified large plan— (i) a summary document for the group health plan that includes such information described in clauses (i) through (iv) of subparagraph (A), as specified by the Secretary through guidance, program instruction, or otherwise (with no requirement of notice and comment rulemaking), that the Secretary determines useful to group health plans for purposes of selecting pharmacy benefit management services, such as an estimated net price to group health plan and participant or beneficiary, a cost per claim, the fee structure or reimbursement model, and estimated cost per participant or beneficiary; (ii) a summary document for plans to provide to participants and beneficiaries, which shall be made available to participants or beneficiaries upon request to their group health plan, that— (I) contains such information described in clauses (iii), (iv), (v), and (vi), as applicable, as specified by the Secretary through guidance, program instruction, or otherwise (with no requirement of notice and comment rulemaking) that the Secretary determines useful to participants or beneficiaries in better understanding the plan or benefits under such plan; (II) contains only aggregate information; and (III) states that participants and beneficiaries may request specific, claims-level information required to be furnished under subsection (c) from the group health plan; and (iii) with respect to drugs covered by such plan during such reporting period— (I) the total net spending by the plan for all such drugs; (II) the total amount received, or expected to be received, by the plan from any applicable entity in rebates, fees, alternative discounts, or other remuneration; and (III) to the extent feasible, information on the total amount of remuneration for such drugs, including copayment assistance dollars paid, copayment cards applied, or other discounts provided by each drug manufacturer (or entity administering copayment assistance on behalf of such drug manufacturer) to participants and beneficiaries; (iv) amounts paid directly or indirectly in rebates, fees, or any other type of compensation (as defined in section 408(b)(2)(B)(ii)(dd)(AA) of the Employee Retirement Income Security Act (29 U.S.C. 1108(b)(2)(B)(ii)(dd)(AA))) to brokerage firms, brokers, consultants, advisors, or any other individual or firm, for— (I) the referral of the group health plan's business to an entity providing pharmacy benefit management services, including the identity of the recipient of such amounts; (II) consideration of the entity providing pharmacy benefit management services by the group health plan; or (III) the retention of the entity by the group health plan; (v) an explanation of any benefit design parameters that encourage or require participants and beneficiaries in such plan to fill prescriptions at mail order, specialty, or retail pharmacies that are affiliated with or under common ownership with the entity providing pharmacy benefit management services under such plan, including mandatory mail and specialty home delivery programs, retail and mail auto-refill programs, and cost-sharing assistance incentives directly or indirectly funded by such entity; and (vi) total gross spending on all drugs under the plan during the reporting period.

(3) In the case of group health insurance coverage offered in connection with a group health plan that is offered by a specified large employer or is a specified large plan, such group health plan may, on an annual basis, for plan years beginning on or after the date that is 30 months after the date of enactment of this section, elect to require an entity providing pharmacy benefit management services on behalf of the health insurance issuer to submit to such group health plan a report that includes all of the information described in paragraph (2)(A), in addition to the information described in paragraph (2)(B).

(4) Privacy requirements (A) An entity providing pharmacy benefit management services on behalf of a group health plan shall report information under paragraph (1) in a manner consistent with the privacy regulations promulgated under section 13402(a) of the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. 17932(a)) and consistent with the privacy regulations promulgated under the Health Insurance Portability and Accountability Act of 1996 in part 160 and subparts A and E of part 164 of title 45, Code of Federal Regulations (or successor regulations) (referred to in this paragraph as the ) and shall restrict the use and disclosure of such information according to such privacy regulations and such HIPAA privacy regulations. "HIPAA privacy regulations" (B) Additional requirements (i) An entity providing pharmacy benefit management services on behalf of a group health plan that submits a report under paragraph (1) shall ensure that such report contains only summary health information, as defined in section 164.504(a) of title 45, Code of Federal Regulations (or successor regulations). (ii) In carrying out this subsection, a group health plan shall comply with section 164.504(f) of title 45, Code of Federal Regulations (or a successor regulation), and a plan sponsor shall act in accordance with the terms of the agreement described in such section. (C) Rule of construction (i) Nothing in this section shall be construed to modify the requirements for the creation, receipt, maintenance, or transmission of protected health information under the HIPAA privacy regulations. (ii) Nothing in this section shall be construed to affect the application of any Federal or State privacy or civil rights law, including the HIPAA privacy regulations, the Genetic Information Nondiscrimination Act of 2008 (Public Law 110–233; 42 U.S.C. 12101 et seq.; 29 U.S.C. 794; 42 U.S.C. 18116; 42 U.S.C. 2000d; 42 U.S.C. 2000e) (including the amendments made by such Act), the Americans with Disabilities Act of 1990 (), section 504 of the Rehabilitation Act of 1973 (), section 1557 of the Patient Protection and Affordable Care Act (), title VI of the Civil Rights Act of 1964 (), and title VII of the Civil Rights Act of 1964 (). (D) Each plan year, group health plans shall provide to each participant or beneficiary written notice informing the participant or beneficiary of the requirement for entities providing pharmacy benefit management services on behalf of the group health plan to submit reports to group health plans under paragraph (1), as applicable, which may include incorporating such notification in plan documents provided to the participant or beneficiary, or providing individual notification. (E) A group health plan receiving a report under paragraph (1) may disclose such information only to the entity from which the report was received or to that entity’s business associates as defined in section 160.103 of title 45, Code of Federal Regulations (or successor regulations) or as permitted by the HIPAA privacy regulations. (F) Nothing in this section shall prevent an entity providing pharmacy benefit management services on behalf of a group health plan, from placing reasonable restrictions on the public disclosure of the information contained in a report described in paragraph (1), except that such plan or entity may not— (i) restrict disclosure of such report to the Department of Health and Human Services, the Department of Labor, or the Department of the Treasury; or (ii) prevent disclosure for the purposes of subsection (c), or any other public disclosure requirement under this section. (G) The Secretary shall define through rulemaking a limited form of the report under paragraph (1) required with respect to any group health plan established by a plan sponsor that is, or is affiliated with, a drug manufacturer, drug wholesaler, or other direct participant in the drug supply chain, in order to prevent anti-competitive behavior.

(5) Standard format and regulations (A) Not later than 18 months after the date of enactment of this section, the Secretary shall specify through rulemaking a standard format for entities providing pharmacy benefit management services on behalf of group health plans, to submit reports required under paragraph (1). (B) Not later than 18 months after the date of enactment of this section, the Secretary shall, through rulemaking, promulgate any other final regulations necessary to implement the requirements of this section. In promulgating such regulations, the Secretary shall, to the extent practicable, align the reporting requirements under this section with the reporting requirements under section 9825. (c) Requirement To provide information to participants or beneficiaries A group health plan, upon request of a participant or beneficiary, shall provide to such participant or beneficiary— (1) the summary document described in subsection (b)(2)(B)(ii); and

(2) the information described in subsection (b)(2)(A)(i)(III) with respect to a claim made by or on behalf of such participant or beneficiary. (d) Rule of construction Nothing in this section shall be construed to permit a health insurance issuer, group health plan, entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer, or other entity to restrict disclosure to, or otherwise limit the access of, the Secretary to a report described in subsection (b)(1) or information related to compliance with subsections (a), (b), or (c) of this section or section 4980D(g) by such issuer, plan, or entity. (e) Definitions In this section: (1) The term applicable entity means— (A) an applicable group purchasing organization, drug manufacturer, distributor, wholesaler, rebate aggregator (or other purchasing entity designed to aggregate rebates), or associated third party; (B) any subsidiary, parent, affiliate, or subcontractor of a group health plan, health insurance issuer, entity that provides pharmacy benefit management services on behalf of such a plan or issuer, or any entity described in subparagraph (A); or (C) such other entity as the Secretary may specify through rulemaking.

(2) The term applicable group purchasing organization means a group purchasing organization that is affiliated with or under common ownership with an entity providing pharmacy benefit management services.

(3) The term contracted compensation means the sum of any ingredient cost and dispensing fee for a drug (inclusive of the out-of-pocket costs to the participant or beneficiary), or another analogous compensation structure that the Secretary may specify through regulations.

(4) The term , with respect to prescription drug benefits under a group health plan, means the amount spent by a group health plan on prescription drug benefits, calculated before the application of rebates, fees, alternative discounts, or other remuneration. gross spending

(5) The term , with respect to prescription drug benefits under a group health plan, means the amount spent by a group health plan on prescription drug benefits, calculated after the application of rebates, fees, alternative discounts, or other remuneration. net spending

(6) The term plan sponsor has the meaning given such term in section 3(16)(B) of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1002(16)(B)).

(7) The term remuneration has the meaning given such term by the Secretary, through rulemaking, which shall be reevaluated by the Secretary every 5 years.

(8) The term specified large employer means, in connection with a group health plan established or maintained by a single employer, with respect to a calendar year or a plan year, as applicable, an employer who employed an average of at least 100 employees on business days during the preceding calendar year or plan year and who employs at least 1 employee on the first day of the calendar year or plan year.

(9) The term specified large plan means a group health plan established or maintained by a plan sponsor described in clause (ii) or (iii) of section 3(16)(B) of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1002(16)(B)) that had an average of at least 100 participants on business days during the preceding calendar year or plan year, as applicable.

(10) The term wholesale acquisition cost has the meaning given such term in section 1847A(c)(6)(B) of the Social Security Act (42 U.S.C. 1395w–3a(c)(6)(B)).;

(C) (i) (I) For plan years beginning on or after the date that is 30 months after the date of enactment of this subparagraph (referred to in this clause as the ), no contract or arrangement or renewal or extension of a contract or arrangement, entered into on or after the effective date, for services between a covered plan and a covered service provider, through a health insurance issuer offering group health insurance coverage, a third party administrator, an entity providing pharmacy benefit management services, or other entity, for pharmacy benefit management services, is reasonable within the meaning of this paragraph unless such entity providing pharmacy benefit management services— "effective date" (II) Nothing in subclause (I) shall be construed to affect the term of a contract or arrangement, as in effect on the effective date (as described in such subclause), except that such subclause shall apply to any renewal or extension of such a contract or arrangement entered into on or after such effective date, as so described. (ii) With respect to such rebates, fees, alternative discounts, and other remuneration— (I) the rebates, fees, alternative discounts, and other remuneration under clause (i)(I) shall be— (II) the Secretary may establish procedures for the remittance of rebates fees, alternative discounts, and other remuneration under subclause (I)(aa) and the disclosure of rebates, fees, alternative discounts, and other remuneration under subclause (I)(bb); and (III) the records of such rebates, fees, alternative discounts, and other remuneration shall be available for audit by the plan sponsor, issuer, or a third party designated by a plan sponsor, not less than once per plan year. (iii) To ensure that an entity providing pharmacy benefit management services is able to meet the requirements of clause (ii)(I), a rebate aggregator (or other purchasing entity designed to aggregate rebates) and an applicable group purchasing organization shall remit such rebates to the entity providing pharmacy benefit management services not later than 45 days after the end of each quarter. (iv) A third-party administrator of a group health plan, a health insurance issuer offering group health insurance coverage, or a covered service provider for pharmacy benefit management services under such health plan or health insurance coverage shall make rebate contracts with rebate aggregators or drug manufacturers available for audit by such plan sponsor or designated third party, subject to reasonable restrictions (as determined by the Secretary) on confidentiality to prevent re-disclosure of such contracts or use of such information in audits for purposes unrelated to this section. (v) Audits carried out under clauses (ii)(III) and (iv) shall be performed by an auditor selected by the responsible plan fiduciary. Payment for such audits shall not be made, whether directly or indirectly, by the entity providing pharmacy benefit management services. (vi) Nothing in this subparagraph shall be construed to— (I) prohibit reasonable payments to entities offering pharmacy benefit management services for bona fide services using a fee structure not described in this subparagraph, provided that such fees are transparent and quantifiable to group health plans and health insurance issuers; (II) require a third-party administrator of a group health plan or covered service provider for pharmacy benefit management services under such health plan or health insurance coverage to remit bona fide service fees to the group health plan; (III) limit the ability of a group health plan or health insurance issuer to pass through rebates, fees, alternative discounts, and other remuneration to the participant or beneficiary; or (IV) modify the requirements for the creation, receipt, maintenance, or transmission of protected health information under the privacy regulations promulgated under the Health Insurance Portability and Accountability Act of 1996 in part 160 and subparts A and E of part 164 of title 45, Code of Federal Regulations (or successor regulations). (vii) For purposes of this subparagraph— (I) the terms and have the meanings given such terms in section 726(e); applicable entity,applicable group purchasing organization (II) the terms , , and have the meanings given such terms in subparagraph (B); and covered plan,covered service provider,responsible plan fiduciary (III) the terms , , and have the meanings given such terms in section 733. group health insurance coverage,health insurance coverage,health insurance issuer.

(H) (i) Upon request (in controlled correspondence or an analogous process) by a person that has submitted or intends to submit an abbreviated application under this subsection for a drug that is required by regulation to contain one or more of the same inactive ingredients in the same concentrations as the listed drug referred to, or for which the Secretary determines there is a scientific justification for an approach that is in vitro, in whole or in part, to be used to demonstrate bioequivalence for a drug if such a drug contains one or more of the same inactive ingredients in the same concentrations as the listed drug referred to, the Secretary shall inform the person whether such drug is qualitatively and quantitatively the same as the listed drug. The Secretary may also provide such information to such a person on the Secretary’s own initiative during the review of an abbreviated application under this subsection for such drug. (ii) Notwithstanding section 301(j), if the Secretary determines that such drug is not qualitatively or quantitatively the same as the listed drug, the Secretary shall identify and disclose to the person— (I) the ingredient or ingredients that cause such drug not to be qualitatively or quantitatively the same as the listed drug; and (II) for any ingredient for which there is an identified quantitative deviation, the amount of such deviation. (iii) If the Secretary determines that such drug is qualitatively and quantitatively the same as the listed drug, the Secretary shall not change or rescind such determination after the submission of an abbreviated application for such drug under this subsection unless— (I) the formulation of the listed drug has been changed and the Secretary has determined that the prior listed drug formulation was withdrawn for reasons of safety or effectiveness; or (II) the Secretary makes a written determination that the prior determination must be changed because an error has been identified. (iv) If the Secretary makes a written determination described in clause (iii)(II), the Secretary shall provide notice and a copy of the written determination to the person making the request under clause (i). (v) The disclosures authorized under clauses (i) and (ii) are disclosures authorized by law, including for purposes of section 1905 of title 18, United States Code. This subparagraph shall not otherwise be construed to authorize the disclosure of nonpublic qualitative or quantitative information about the ingredients in a listed drug, or to affect the status, if any, of such information as trade secret or confidential commercial information for purposes of section 301(j) of this Act, section 552 of title 5, United States Code, or section 1905 of title 18, United States Code..

(7) (A) Subject to subparagraphs (C), (D), and (E), if the sponsor of an approved application for a reference product, as defined in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i)) (referred to in this paragraph as the ), brings an action for infringement under this section against an applicant for approval of a biological product under section 351(k) of such Act that references that reference product (referred to in this paragraph as the ), the reference product sponsor may assert in the action a total of not more than 20 patents of the type described in subparagraph (B), not more than 10 of which shall have issued after the date specified in section 351(l)(7)(A) of such Act. "reference product sponsor" "subsection (k) applicant" (B) The patents described in this subparagraph are patents that satisfy each of the following requirements: (i) Patents that claim the biological product that is the subject of an application under section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)) (or a use of that product) or a method or product used in the manufacture of such biological product. (ii) Patents that are included on the list of patents described in paragraph (3)(A) of section 351(l) of the Public Health Service Act (42 U.S.C. 262(l)), including as provided under paragraph (7) of such section 351(l). (iii) Patents that— (I) have an actual filing date of more than 4 years after the date on which the reference product is approved; or (II) include a claim to a method in a manufacturing process that is not used by the reference product sponsor. (C) The court in which an action described in subparagraph (A) is brought may increase the number of patents limited under that subparagraph— (i) if the request to increase that number is made without undue delay; and (ii) (I) if the interest of justice so requires; or (II) for good cause shown, which— (D) In determining whether good cause has been shown for the purposes of subparagraph (C)(ii)(II), a court may consider whether the reference product sponsor has provided a reasonable description of the identity and relevance of any information beyond the subsection (k) application that the court believes is necessary to enable the court to form a belief with respect to whether a claim of infringement under this section could reasonably be asserted. (E) The limitation imposed under subparagraph (A)— (i) shall apply only if the subsection (k) applicant completes all actions required under paragraphs (2)(A), (3)(B)(ii), (5), (6)(C)(i), (7), and (8)(A) of section 351(l) of the Public Health Service Act (42 U.S.C. 262(l)); and (ii) shall not apply with respect to any patent that claims, with respect to a biological product, a method for using that product in therapy, diagnosis, or prophylaxis, such as an indication or method of treatment or other condition of use..