Overview
Title
To amend the Public Health Service Act to reform the 340B drug pricing program, and for other purposes.
ELI5 AI
The bill is like making new rules for a club that helps doctors and hospitals get cheaper medicine for people who don't have much money. These rules make sure everyone is playing fair, checking their work, and not taking advantage of the cheaper prices.
Summary AI
H.R. 8574 aims to reform the 340B drug pricing program, which provides discounted medications to healthcare providers serving low-income communities. The bill introduces new rules and requirements for hospitals and pharmacies to participate in the program, ensuring accountability and transparency in the purchasing and dispensing of drugs. It also sets penalties for non-compliance and prohibits certain discriminatory practices against entities using 340B discounts. Additionally, the bill includes measures to ensure that drug discounts are not duplicated and establishes a clearinghouse for managing claims data.
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AnalysisAI
The proposed legislation titled "340B ACCESS Act," aims to amend the Public Health Service Act to refine the 340B drug pricing program. This program is designed to provide discounted medication to covered entities that serve vulnerable communities. The bill outlines various measures to ensure transparency, prevent duplicate Medicaid discounts, and enforce compliance with the program's requirements. It sets out specific rules for entities, including hospitals and pharmacies, involved in the distribution of these drugs, dictates criteria for program participation, and implements reporting and auditing systems.
Key Issues
One significant concern with the bill is the complexity and broadness of definitions such as "patient," "covered entity," and "contract pharmacy." These terms are pivotal for determining eligibility and benefits but are intricate and may lead to varying interpretations. This ambiguity could result in inconsistent application of the program, potentially leading to legal challenges.
The bill grants substantial authority to the Secretary for imposing civil monetary penalties on entities that fail to comply with the new guidelines. While aimed at ensuring accountability, the lack of detailed criteria for these penalties could lead to perceptions of arbitrary enforcement. This may present a financial burden on entities, particularly affecting their ability to continue serving vulnerable populations.
Another issue pertains to the administrative demands placed on covered entities. The requirement to maintain extensive records, undergo audits, and comply with new reporting standards could divert resources from patient care. This concern is amplified for smaller entities with limited administrative capacities, potentially hindering their service delivery.
Limitations on contract pharmacy agreements, particularly for certain hospital entities, might restrict drug access in rural or underserved areas. This could decrease patient access to needed medications, affecting community health outcomes. The directives on remuneration for third-party administrators and contract pharmacies might also reduce the flexibility required for fair compensation, complicating compliance with state and federal laws.
Impacts on the Public and Stakeholders
Broadly, the bill targets enhancing operational transparency and accountability for entities involved in the 340B program, which could ensure fairer distribution of discounted drugs. If successful, this might lead to improved access to affordable healthcare for underserved communities. However, the complexity of compliance requirements and the potential costs associated with penalties could threaten the viability of some entities, especially those serving remote or underserved populations.
For specific stakeholders such as small hospitals and public health entities, the administrative and financial burdens introduced by the bill could be significant. They might struggle with compliance due to limited resources, potentially leading to reduced capacity to serve communities. On the other hand, increased regulation might benefit larger, well-resourced entities able to navigate these complexities more efficiently.
Overall, while the bill intends to fortify the 340B program's integrity, its complex provisions could present challenges in execution. Ensuring that entities are not disproportionately burdened and that the public continues to receive improved access to medication should be pivotal considerations as the legislation progresses.
Financial Assessment
The bill, H.R. 8574, involves several financial implications aimed at reforming the 340B drug pricing program. It specifies different monetary penalties, adjustments, and definitions related to the financial interactions within the program. These financial elements play directly into some of the identified issues with the bill.
Financial Penalties and Compliance Costs
One of the notable financial aspects of the bill is the introduction of civil monetary penalties. For instance, the bill states that a covered entity that knowingly and intentionally violates certain requirements must pay a penalty of $2,500 for each violation, which will be adjusted annually for inflation using the Consumer Price Index for All Urban Consumers. This is articulated in Sections 4, 6, 8, and 12. Moreover, the penalties for contract pharmacies can go up to $13,946 per claim for repeated violations (Section 5).
The broad authority granted to impose these financial penalties without extensive guidelines (Sections 15 and 19) raises concerns about potential arbitrary enforcement. This financial burden could disproportionately affect smaller healthcare entities with limited resources, potentially impacting their capacity to deliver care to vulnerable populations. Hence, while financial penalties are intended to ensure compliance, they also represent a risk of financial strain on smaller entities, potentially diverting funds away from patient care (Section 8).
Definitions and Financial Implications
The bill defines "specified nonhospital covered entity" in financial terms, with an emphasis on operational revenues exceeding $1,000,000,000 or affiliation with a hospital (Section 2). The broad nature of these definitions might lead to ambiguity in application, causing inconsistencies and potential legal challenges. Lack of clarity around terms like "fair market value" and "similarly situated" entities (Sections 5 and 17) may lead to financial disputes over appropriate reimbursements and penalties.
Administrative and Operational Costs
Several sections outline administrative requirements, which indirectly translate to financial costs for participating entities. For example, covered entities that fail to furnish required information face a civil monetary penalty of $2,500 for each day of violation (Section 8). The obligation for extensive record-keeping and audits (Sections 8, 10, 12) implies significant administrative costs. Smaller organizations may struggle with these financial and logistical burdens, potentially affecting their ability to focus on healthcare service delivery.
Restrictions on Pharmacy Agreements
The bill places limitations on contract pharmacy agreements for specific hospital entities (Section 5), introducing potential barriers to comprehensive drug access. These restrictions could limit the ability of healthcare entities to leverage varied pharmacy networks, thus financially impacting how services are provided, especially in underserved areas. This restriction could be seen as a financial limitation on operational flexibility, potentially reducing patient access to necessary medications.
Remuneration for Services
The bill dictates that third-party administrators and contract pharmacies receive remuneration only as a flat dollar amount (Section 17). This remuneration structure, consistent with fair market value and not based on drug prices, may complicate financial arrangements and limit flexibility in compensation. These financial controls are intended to prevent inflated costs, but they could also inhibit necessary operational adjustments in how services are remunerated.
Timelines and Adjustments
Lastly, the one-year effective date imposed for these financial and administrative changes (Section 20) may not provide sufficient time for many entities to adapt, especially those with fewer resources. This timeline could force entities to hastily implement changes, possibly leading to financial inefficiencies or hurried compliance measures that favor larger, better-resourced entities.
Through these financial references, H.R. 8574 seeks to maintain accountability within the 340B program but also poses several financial challenges and implications for participating entities.
Issues
The requirement for private nonprofit hospitals to provide health care services to low-income uninsured individuals as a condition for participating in the 340B program may unfairly exclude hospitals in states with less financial flexibility or lower uninsured populations, potentially disrupting access to affordable drugs for underserved communities. (Sections 11, 12)
The complexity and broad definitions provided in the bill, such as for 'patient,' 'covered entity,' and 'contract pharmacy,' may lead to ambiguity in interpretation and application, creating potential for inconsistent application and legal challenges. (Sections 2, 2730)
The broad authority granted to the Secretary to impose civil monetary penalties without detailed guidelines could lead to perceptions of arbitrary enforcement and potential financial burdens on covered entities and pharmacies, impacting their ability to serve vulnerable populations. (Sections 15, 19)
The requirement for covered entities to maintain extensive records and conduct audits may impose significant administrative burdens, potentially diverting resources from patient care. This could particularly impact smaller entities with limited administrative capacity. (Sections 8, 10, 12)
The limitation on contract pharmacy agreements for specific hospital covered entities might restrict the ability of some entities to provide comprehensive drug access, especially in rural or underserved areas, thus reducing patient access to necessary medications. (Sections 5, 2730)
The lack of specific definitions or explicit illustrations in the bill, particularly regarding terms such as 'fair market value' and 'similarly situated,' may lead to varying interpretations, potential disputes, and differences in how the regulations are applied across different entities. (Sections 5, 17, 2730)
The constraints placed on third-party administrators and contract pharmacies regarding remuneration could limit the flexibility needed for fair compensation and may also increase complexity in ensuring compliance with existing State and Federal laws, potentially affecting the viability of pharmacy services involved in the program. (Section 17)
The one-year effective date timeline might be too short for many entities to adequately adjust to new compliance requirements, potentially causing implementation challenges, particularly for entities with fewer resources. (Section 20)
Sections
Sections are presented as they are annotated in the original legislative text. Any missing headers, numbers, or non-consecutive order is due to the original text.
1. Short title; table of contents Read Opens in new tab
Summary AI
The "340B ACCESS Act" aims to enhance the 340B drug pricing program by setting rules and requirements for hospitals and other entities to ensure drug affordability for patients, improve program transparency, and prevent Medicaid duplicate discounts. The Act outlines various responsibilities for covered entities and introduces measures for oversight, compliance, and reporting related to drug pricing and distribution.
2. Definitions Read Opens in new tab
Summary AI
This section updates the definition of a "patient" in the Public Health Service Act to specify when an individual qualifies for certain drug pricing benefits under the 340B program. It details the requirements for a healthcare provider's relationship with the patient and conditions under which telehealth services apply. Additionally, it defines a "specified nonhospital covered entity" based on revenue and affiliations with hospitals.
Money References
- (b) Definition of specified nonhospital covered entity.—Section 340B(b) of the Public Health Service Act (42 U.S.C. 256b(b)) is further amended by adding at the end the following: “(4) SPECIFIED NONHOSPITAL COVERED ENTITY.—In this section, the term ‘specified nonhospital covered entity’ means a covered entity that— “(A) is described in one of subparagraphs (B) through (K) of subsection (a)(4), other than a covered entity described in subparagraph (G) of such subsection, and— “(i) has average annual operating revenues exceeding $1,000,000,000 calculated over the most recent three-year period for which data are available, which revenue threshold shall be adjusted for inflation annually to reflect rate of change in the Consumer Price Index for All Urban Consumers published by the Bureau of Labor Statistics; or “(ii) is an affiliate of a hospital; or “(B) is described in subsection (a)(4)(A) and becomes affiliated with a hospital on or after December 1, 2023.
3. Prevention of Medicaid duplicate discounts; oversight of covered entities Read Opens in new tab
Summary AI
The section amends the Public Health Service Act to enhance rules around Medicaid and the 340B drug pricing program. It requires the creation of regulations to prevent duplicate discounts on drugs, mandates audits of how covered entities use their drug-related profits, and establishes better processes for managing Medicaid rebates on 340B drugs.
4. Hospital child site requirements Read Opens in new tab
Summary AI
The bill modifies the Public Health Service Act to establish specific requirements that off-campus outpatient facilities must meet to be considered "child sites" and partake in the 340B drug pricing program as part of a hospital or similar entity. These requirements include factors such as cost report filings, ownership details, adherence to charity care policies, and location in areas with health service shortages. It also imposes penalties for non-compliance and mandates annual reporting by the Secretary to ensure transparency.
Money References
- “(v) CIVIL MONETARY PENALTY.—Where a covered entity knowingly and intentionally violates clause (ii) or otherwise fails to satisfy a requirement in clause (iii) or clause (iv), the covered entity shall be required to pay a civil monetary penalty equal to $2,500 for each such violation, which amount shall be adjusted for inflation annually to reflect the rate of change in the Consumer Price Index for All Urban Consumers published by the Bureau of Labor Statistics.
5. Contract pharmacies Read Opens in new tab
Summary AI
The section introduces amendments related to contract pharmacies under the Public Health Service Act's 340B program. It outlines the conditions under which covered entities can partner with contract pharmacies to distribute discounted drugs and includes rules about compliance, registration, limitations on the number of pharmacies, service area requirements, penalties for violations, and clarifies definitions and requirements for mail order pharmacies.
Money References
- — “(I) IN GENERAL.—A contract pharmacy that is found to have violated the covered entity compliance procedures described in clause (ii)(II), violated subparagraph (A), or violated subparagraph (B) shall— “(aa) in the first instance of such violation, be liable to a manufacturer of a covered outpatient drug that is the subject of such violation in an amount equal to the reduction in the price of such drug (as described in subsection (a)(1)), plus interest on such amount, which shall be compounded monthly and equal to the current short-term interest rate as determined by the Federal Reserve for the time period for which the covered entity is liable; “(bb) in the second instance of such violation— “(AA) be liable to a manufacturer of a covered outpatient drug that is the subject of such violation in an amount equal to the reduction in the price of the drug (as described in paragraph (1)), plus interest on such amount, which shall be calculated in the manner specified in item (aa); and “(BB) be required to pay a civil monetary penalty equal to $13,946 for each claim for a covered outpatient drug that is subject to the violation, which amount shall be adjusted for inflation annually to reflect the rate of change in the Consumer Price Index for All Urban Consumers published by the Bureau of Labor Statistics; and
- “(cc) in the third instance of such violation— “(AA) be liable to a manufacturer of a covered outpatient drug that is the subject of such violation in an amount equal to the reduction in the price of the drug (as described in paragraph (1)), plus interest on such amount, which shall be calculated in the manner specified in item (aa); “(BB) be required to pay a civil monetary penalty equal to $13,946 for each claim for a covered outpatient drug that is subject to the violation, which amount shall be adjusted for inflation annually to reflect the rate of change in the Consumer Price Index for All Urban Consumers published by the Bureau of Labor Statistics; and “(CC) be removed from the program under this section and disqualified from reentry into such program for a period of not less than two years, or such longer period as the Secretary may determine based on the severity of the violation (or violations) and the risk such pharmacy presents to the integrity of the program, with no ability to reenter the program unless and until the Secretary determines such pharmacy has resolved the violation (or violations) and taken reasonable steps to prevent similar future violations.
- “(bb) the pharmacy shall prepare a written corrective action plan, in a form specified by the Secretary, which shall include, at a minimum, the results of such internal review, the pharmacy’s methodology for identifying the full scope of such violation (or violations), and the pharmacy’s proposed corrective actions, and submit such plan to the Secretary in a form and manner specified by the Secretary; and “(cc) the Secretary shall review such plan, notify the pharmacy of any revisions to such plan, including additional corrective actions, necessary for the Secretary to approve such plan, and publish the approved plan on a public website of the Department of Health and Human Services (with redactions of any confidential or proprietary information). “(III) CIVIL MONETARY PENALTY FOR VIOLATIONS BY REMOVED PHARMACY.—A contract pharmacy removed from the program under this section pursuant to subclause (I)(cc) that dispenses a covered outpatient drug subject to an agreement under this section during a time period that such pharmacy is removed from the program and is not approved for reentry shall be required to pay a civil monetary penalty equal to $13,946 for each claim for each such drug dispensed during such period, which amount shall be adjusted for inflation annually to reflect the rate of change in the Consumer Price Index for All Urban Consumers published by the Bureau of Labor Statistics.
6. Ensuring patient affordability of drugs purchased under section 340B Read Opens in new tab
Summary AI
The section amends the Public Health Service Act to ensure affordability for patients purchasing drugs under section 340B by requiring covered hospitals and certain other entities to offer sliding fee scales and discounts based on a patient's income and insurance status. It also mandates that contract pharmacies comply with these requirements, imposes penalties for violations, and calls for annual studies to assess the effectiveness of these measures in reducing out-of-pocket costs for eligible patients.
Money References
- , the maximum out-of-pocket obligation for an eligible patient with family income— “(I) below the Federal poverty guidelines is $0; “(II) at or above the Federal poverty guidelines but below 200 percent of the Federal poverty guidelines is the lesser of 20 percent of the otherwise applicable out-of-pocket obligation or $35, which shall be adjusted for inflation annually to reflect rate of the change in the Consumer Price Index for All Urban Consumers published by the Bureau of Labor Statistics; and
- “(III) at or above 200 percent of the Federal poverty guidelines is the lesser of 30 percent of the otherwise applicable out-of-pocket obligation or $50, which shall be adjusted for inflation annually to reflect rate of the change in the Consumer Price Index for All Urban Consumers published by the Bureau of Labor Statistics.
- “(v) CIVIL MONETARY PENALTY.—A covered entity or contract pharmacy that violates a requirement of this subparagraph shall be subject to a civil monetary penalty of $2,500 for each such violation, which amount shall be adjusted for inflation annually to reflect the rate of change in the Consumer Price Index for All Urban Consumers published by the Bureau of Labor Statistics.
7. Requirements for nonhospital covered entities and subgrantees Read Opens in new tab
Summary AI
This section outlines additional rules for certain nonprofit or public entities and their subgrantees to participate in a program under the Public Health Service Act. These entities must enter into written agreements, keep records, and meet specific conditions related to federal grants and the services they provide, while subgrantees must demonstrate they meet similar criteria to remain eligible for the program.
Money References
- — “(I) IN GENERAL.—In this subparagraph, the term ‘subgrantee’ means a subrecipient of a Federal grant that— “(aa) receives eligible Federal funds from a covered entity described in one of subparagraphs (A) through (K) of paragraph (4) in the form of nonnominal and ongoing payments by such covered entity directly to such subrecipient to directly support the provision of health care services by such subrecipient to individuals within the scope and time period of the Federal grant, project, or Federal grant-authorizing statute, as applicable, that qualifies such covered entity for participation in the program under this section; or “(bb) receives in-kind contributions from a covered entity described in paragraph (4)(K) and such contributions— “(AA) are ongoing and are in the form of real property, equipment, supplies, or services; “(BB) subject to subclause (II), have a value exceeding $25,000 per year, which shall be adjusted for inflation annually to reflect the rate of change in the Consumer Price Index for All Urban Consumers published by the Bureau of Labor Statistics and determined by the subrecipient and approved by the covered entity providing such contribution in a manner specified by the Secretary; “(CC) are specifically identifiable and provided by such covered entity directly to such subrecipient; and “(DD) directly support the provision of health care items and services by such subrecipient solely to individuals within the scope and time period of the Federal grant that qualifies such covered entity for participation in the program under this section. “
8. Claims modifiers; covered entity data submission Read Opens in new tab
Summary AI
The section amends the Public Health Service Act to require covered entities and contract pharmacies to include specific claims modifiers for drugs bought under the 340B program when seeking reimbursement from payors like Medicare and Medicaid. Additionally, these entities must submit detailed data about each drug they dispense to a central clearinghouse while ensuring the privacy and security of the data, and they face penalties for failing to comply with these reporting requirements.
Money References
- In specifying the data submission standards described in this clause, the clearinghouse and the Secretary, as applicable, shall seek to minimize administrative burden on covered entities while ensuring such data satisfies the intent of this subparagraph. “(vi) COVERED ENTITIES THAT FAIL TO REPORT.—A covered entity that fails to furnish the information as required under this subparagraph shall be subject to a civil monetary penalty in the amount of $2,500 for each day of such violation, which amount shall be adjusted for inflation annually to reflect the rate of change in the Consumer Price Index for All Urban Consumers published by the Bureau of Labor Statistics.
9. Covered entity reporting on scope of grant, contract, and project Read Opens in new tab
Summary AI
A new reporting requirement has been added to the Public Health Service Act, requiring certain entities to submit details about their federal grants or projects to an identification system every year. This information will be shared with drug manufacturers if they request it, following guidance from the Secretary.
10. Ensuring covered entity transparency Read Opens in new tab
Summary AI
The section requires certain healthcare entities, known as covered entities, to report detailed information annually to the Secretary of Health and Human Services, including data on the number of patients receiving outpatient drugs, the costs and margins related to these drugs, and the expenditures in various care categories. This information will be published on a public website, and the Secretary must issue rules to implement these requirements within 180 days of the law's enactment.
11. Revisions to existing 340B hospital eligibility requirements Read Opens in new tab
Summary AI
The section updates hospital eligibility rules for the 340B drug pricing program. It requires certain hospitals, like critical access hospitals and rural emergency hospitals, to be registered by the end of 2023 and meet specific criteria, such as serving a predominantly rural population.
12. Additional requirements for 340B hospitals Read Opens in new tab
Summary AI
Section 12 of the bill amends the Public Health Service Act to outline specific eligibility requirements and obligations for certain private non-profit hospitals that participate in the 340B drug pricing program. It establishes conditions such as contracts with state or local governments, public availability of information, and financial penalties for non-compliance, while also prohibiting aggressive debt collection practices against uninsured or low-income patients.
Money References
- “(D) CIVIL MONETARY PENALTY.—Where a covered entity fails to satisfy a requirement in subparagraph (B) or (C), the covered entity shall be required to pay a civil monetary penalty equal to $2,500 for each violation, which amount shall be adjusted for inflation annually to reflect the rate of change in the Consumer Price Index for All Urban Consumers published by the Bureau of Labor Statistics.
- “(F) CIVIL MONETARY PENALTY.—Where a covered entity fails to satisfy a requirement in subparagraph (D) or (E), the covered entity shall be required to pay a civil monetary penalty equal to $2,500 for each violation, which amount shall be adjusted for inflation annually to reflect the rate of change in the Consumer Price Index for All Urban Consumers published by the Bureau of Labor Statistics.
- “(C) CIVIL MONETARY PENALTY.—Where a covered entity violates the prohibition in this paragraph, the covered entity shall be required to pay a civil monetary penalty equal to $2,500 for each extraordinary collection action taken with respect to an individual described in this paragraph, which amount shall be adjusted for inflation annually to reflect the rate of change in the Consumer Price Index for All Urban Consumers published by the Bureau of Labor Statistics.
- “(F) CIVIL MONETARY PENALTY.—Where a covered entity fails to satisfy a requirement in subparagraph (D) or (E), the covered entity shall be required to pay a civil monetary penalty equal to $2,500 for each violation, which amount shall be adjusted for inflation annually to reflect the rate of change in the Consumer Price Index for All Urban Consumers published by the Bureau of Labor Statistics.
13. 340B program Read Opens in new tab
Summary AI
The section adds a new part to the Public Health Service Act that aims to lower drug prices for certain health providers. These providers serve communities that don't have enough access to affordable medicine and health services, helping them get the care they need.
14. Audits of private nonhospital contracts with State and local governments Read Opens in new tab
Summary AI
In this section, it is amended to require the Secretary to conduct annual audits on contracts between certain nonprofit hospitals and state or local governments to ensure they meet specific requirements. Hospitals that fail to comply may be removed from the discount drug program, need to audit their drug purchases, and possibly face financial penalties.
Money References
- Where a covered entity described in this clause knowingly and intentionally violates a requirement in subsection (a)(4)(L)(i) or (a)(11), the covered entity shall be required to pay a civil monetary penalty equal to $1,000 for each claim for a covered outpatient drug that is subject to the violation, which amount shall be adjusted for inflation annually to reflect the rate of change in the Consumer Price Index for All Urban Consumers published by the Bureau of Labor Statistics.
15. Ensuring covered entity compliance with transparency requirements Read Opens in new tab
Summary AI
The amended section of the Public Health Service Act allows the Secretary to impose civil monetary penalties on covered entities if they fail to comply with certain transparency requirements.
16. 340B claims data clearinghouse Read Opens in new tab
Summary AI
Congress has proposed changes to the Public Health Service Act to create a 340B claims data clearinghouse. The clearinghouse will manage and identify claims for discounted drugs to avoid duplications and ensure accurate rebate handling for Medicaid and Medicare, while sharing relevant data with drug manufacturers in a secure and private manner.
17. Limitation on administrator service fees and contract pharmacy fees Read Opens in new tab
Summary AI
This section introduces limitations on fees that third-party administrators and contract pharmacies can charge when providing services related to the 340B drug pricing program. Third-party administrators are allowed to receive flat fees that must reflect fair market value and comply with laws, while contract pharmacies can charge fees up to 125% of average dispensing fees based on recent data. Non-compliance can result in significant financial penalties.
Money References
- only if— “(A) such remuneration is a flat dollar amount not directly or indirectly based on any price of, or discount or other remuneration provided with respect to, a covered outpatient drug, paid for each unit of service furnished to the covered entity, regardless of whether a prescription was dispensed to an individual who is a patient of the covered entity; “(B) the amount of such remuneration is consistent with fair market value in an arm’s-length transaction for the bona fide, itemized 340B-related services actually performed on behalf of the covered entity; and “(C) such remuneration complies with applicable State and Federal law, including section 1128B(b) of the Social Security Act.
- “(2) CONTRACT PHARMACY FEES.—A contract pharmacy that has entered into a written agreement with a covered entity pursuant to and satisfies the applicable requirements in subsection (a)(5)(F) may receive remuneration from such covered entity for the performance of services associated with dispensing covered outpatient drugs subject to an agreement under this section to individuals who are patients of the covered entity (as defined in subsection (b)(3)) only if— “(A) such remuneration is a flat dollar amount not directly or indirectly based on any price of, or discount or other remuneration provided with respect to, a covered outpatient drug, paid for each dispense of such a drug to a patient of the covered entity; “(B) the amount of remuneration for each dispense does not exceed 125 percent of the average per-prescription dispensing fee paid to such pharmacy by all third-party payors, based on data from the most recent full calendar year for which such data is available; “(C) the amount of such remuneration is consistent with fair market value in an arm’s-length transaction for the bona fide, itemized 340B-related services actually performed on behalf of the covered entity; and “(D) such remuneration complies with applicable State and Federal law, including section 1128B(b) of the Social Security Act.
18. Clarification Read Opens in new tab
Summary AI
The new amendment to Section 340B of the Public Health Service Act clarifies that its rules override any conflicting state or local laws regarding drug discount programs, except for specific State regulations linked to subsection (a)(5)(A)(iii). No state or local laws can create additional rules or rights concerning the 340B program apart from these exceptions.
19. Ensuring the equitable treatment of 340B covered entities and pharmacies participating in the 340B drug discount program Read Opens in new tab
Summary AI
The section ensures fair treatment of pharmacies and entities in the 340B drug discount program by prohibiting discrimination in terms of reimbursement and conditions, requiring adherence to 340B affordability assistance, and imposing penalties for violations. It also extends these requirements to certain Medicare contracts, ensuring they align with the 340B program's conditions.
Money References
- Such penalty shall not exceed $5,000 per violation per day.
2730. Requirements relating to the 340B drug discount program Read Opens in new tab
Summary AI
The section outlines that health plans, insurers, and pharmacy benefit managers cannot treat 340B entities differently or discriminate against them by imposing extra conditions or reimbursement terms. It also prohibits interfering with individuals' access to 340B drugs and requires monetary penalties for violations.
Money References
- Such penalty shall not exceed $5,000 per violation per day.
20. Effective date Read Opens in new tab
Summary AI
The law states that, unless stated otherwise, all the rules in this Act will start being enforced one year after the Act is officially passed.