S3548-118

2. Strengthening hospital price transparency requirements Section 2718(e) of the Public Health Service Act (42 U.S.C. 300gg–18(e)) is amended to read as follows: For purposes of paragraph (1), the price transparency requirement described in this paragraph is, with respect to a hospital, that such hospital, in accordance with a method and format established by the Secretary under subparagraph (C), compile and make public (without subscription and free of charge) for each month— all of the hospital’s standard charges (including the information described in subparagraph (B)) for each item and service furnished by such hospital; and information in a consumer-friendly format (as specified by the Secretary)— on the hospital’s prices (including the information described in subparagraph (B)) for as many of the Centers for Medicare & Medicaid Services-specified shoppable services that are furnished by the hospital, and as many additional hospital-selected shoppable services (or all such additional services, if such hospital furnishes fewer than 300 shoppable services) as may be necessary for a combined total of at least 300 shoppable services through December 31, 2024, after which the hospital’s prices shall include all shoppable services; and that includes, with respect to each Centers for Medicare & Medicaid Services-specified shoppable service that is not furnished by the hospital, an indication that such service is not so furnished. For purposes of subparagraph (A), the information described in this subparagraph is, with respect to standard charges and prices, as applicable, made public by a hospital, the following: A plain language description of each item or service, accompanied by any applicable billing codes, including modifiers, using commonly recognized billing code sets, including the Current Procedural Terminology code, the Healthcare Common Procedure Coding System code, the diagnosis-related group, the National Drug Code, and other nationally recognized identifier. The gross charge, as applicable, expressed as a dollar amount, for each such item or service, when provided in, as applicable, the inpatient setting and outpatient department setting. The discounted cash price, as applicable, expressed as a dollar amount, for each such item or service when provided in, as applicable, the inpatient setting and outpatient department setting (or, in the case no discounted cash price is available for an item or service, the minimum cash price accepted by the hospital from self-pay individuals for such item or service, expressed as a dollar amount, as well as, with respect to prices made public pursuant to subparagraph (A)(ii), a link to a consumer-friendly document that clearly explains the hospital’s charity care policy). The hospital shall accept the discounted cash price as payment in full from any patient that chooses to pay in cash without regard to the patient’s coverage. The payer-specific negotiated charges, expressed as a dollar amount and clearly associated with the name of the applicable third party payer and name of each plan, that apply to each such item or service when provided in, as applicable, the inpatient setting and outpatient department setting. If the charges are based on an algorithm, percentage of another amount, or other formula or criteria, the hospital also shall disclose such algorithm, percentage, formula, or criteria as set forth in its contract and any other terms, schedules, exhibits, data, or other information referenced in any such contract as shall be required to determine and disclose the negotiated charge. The de-identified maximum and minimum negotiated charges, as applicable, for each such item or service, expressed as a non-zero dollar amount. Any other additional information the Secretary may require for the purpose of improving the accuracy of, or enabling consumers to easily understand and compare, standard charges and prices for an item or service, except information that is duplicative of any other reporting requirement under this subsection. In the case of standard charges and prices for an item or service included as part of a bundled, per diem, episodic, or other similar arrangement, the information described in this subparagraph shall be made available as determined appropriate by the Secretary. Not later than January 1, 2025, the Secretary shall establish a standard, uniform method and format for hospitals to use in compiling and making public standard charges pursuant to subparagraph (A)(i) and a standard, uniform method and format for such hospitals to use in compiling and making public prices pursuant to subparagraph (A)(ii). Such methods and formats— shall, in the case of such method and format for making public standard charges pursuant to subparagraph (A)(i), ensure that such charges are made available in a machine-readable spreadsheet format; may be similar to any template made available by the Centers for Medicare & Medicaid Services as of the date of the enactment of this subparagraph; shall meet such standards as determined appropriate by the Secretary in order to ensure the accessibility and usability of such charges and prices; and shall be updated as determined appropriate by the Secretary, in consultation with stakeholders. The availability of a price estimator tool shall not be considered to deem compliance with or otherwise vitiate the requirements of paragraph (2)(A)(ii) or any other requirements of this section. Furthermore, the use of an estimator tool shall not be used for purposes of compliance with any provisions in this Section. The Secretary shall, in consultation with the Inspector General of the Department of Health and Human Services, establish a process to monitor compliance with this subsection. Such process shall ensure that each hospital’s compliance with this subsection is reviewed not less frequently than once every year. A senior official from each hospital (the Chief Executive Officer, Chief Financial Officer, or an official of equivalent seniority) shall attest to the accuracy and completeness of the disclosures made in accordance with the hospital price transparency requirements set forth in this regulation. Such attestation shall be deemed to be material to payment from the Federal Government to the hospital. In the case of a hospital that fails to comply with the requirements of this subsection, not later than 30 days after the date on which the Secretary determines such failure exists, the Secretary shall submit to such hospital a notification of such determination, which shall include a request for a corrective action plan to comply with such requirements. In addition to any other enforcement actions or penalties that may apply under another provision of law, a hospital that has received a request for a corrective action plan under subparagraph (A) and fails to comply with the requirements of this subsection by the date that is 45 days after such request is made shall be subject to a civil monetary penalty of an amount specified by the Secretary for each day (beginning with the day on which the Secretary first determined that such hospital was not complying with such requirements) during which such failure was ongoing. Such amount shall not exceed— in the case of a hospital with 30 or fewer beds, $300 per day; in the case of a hospital with more than 30 beds but fewer than 101 beds, $10 per bed per day (or, in the case of such a hospital that has been noncompliant with such requirements for a 1-year period or longer, beginning with the first day following such 1-year period, $12.50 per bed per day); in the case of a hospital with more than 100 beds but fewer than 301 beds, $15 per bed per day (or, in the case of such a hospital that has been noncompliant with such requirements for a 1-year period or longer, beginning with the first day following such 1-year period, $17.50 per bed per day); in the case of a hospital with more than 300 beds but fewer than 501 beds, $20 per bed per day (or, in the case of such a hospital that has been noncompliant with such requirements for a 1-year period or longer, beginning with the first day following such 1-year period, $25 per bed per day); and in the case of a hospital with more than 500 beds, $25 per bed per day (or, in the case of such a hospital that has been noncompliant with such requirements for a 1-year period or longer, beginning with the first day following such 1-year period, $35 per bed per day). In applying this subparagraph with respect to violations occurring in 2027 or a subsequent year, the Secretary may through notice and comment rulemaking increase— the limitation on the per day amount of any penalty applicable to a hospital under clause (i)(I); the limitations on the per bed per day amount of any penalty applicable under any of subclauses (II) through (V) of clause (i); and the limitation on the increase of any penalty applied under clause (iii) pursuant to the amounts specified in subclause (II) of such clause. In the case of a hospital that the Secretary has determined to be knowingly and willfully noncompliant with the provisions of this subsection two or more times during a 1-year period, the Secretary may increase any penalty otherwise applicable under this subparagraph by the amount specified in subclause (II) with respect to such hospital and may require such hospital to complete such additional corrective actions plans as the Secretary may specify. For purposes of subclause (I), the amount specified in this subclause is, with respect to a hospital— with more than 30 beds but fewer than 101 beds, an amount that is not less than $500,000 and not more than $1,000,000; with more than 100 beds but fewer than 301 beds, an amount that is greater than $1,000,000 and not more than $2,000,000; with more than 300 beds but fewer than 501 beds, an amount that is greater than $2,000,000 and not more than $4,000,000; and with more than 500 beds, and amount that is not less than $5,000,000 and not more than $10,000,000. The Secretary may, to the extent practicable, provide technical assistance relating to compliance with the provisions of this section to hospitals requesting such assistance. The provisions of section 1128A (other than subsections (a) and (b) of such section) shall apply to a civil monetary penalty imposed under this subparagraph in the same manner as such provisions apply to a civil monetary penalty imposed under subsection (a) of such section. The Secretary shall not grant or extend any waiver, delay, tolling, or other mitigation of a civil monetary penalty for violation of this subsection. For purposes of this subsection: The term discounted cash price means the minimum charge that the hospital accepts from an individual who pays cash, or cash equivalent, for a hospital-furnished item or service. The term gross charge means the charge for an individual item or service that is reflected on a hospital’s chargemaster, absent any discounts. The term hospital means a hospital (as defined in section 1861(e) of the Social Security Act), a critical access hospital (as defined in section 1861(mmm)(1) of the Social Security Act), or a rural emergency hospital (as defined in section 1861(kkk) of the Social Security Act), together with any parent, subsidiary, or other affiliated provider or supplier of health care items and services without regard to whether such parent, subsidiary, or other affiliated provider or supplier operates under separate licensure, certification, or designation. The term payer-specific negotiated charge means the charge that a hospital has negotiated with a third party payer for an item or service. The term shoppable service means a service that can be scheduled by a health care consumer in advance and includes all ancillary items and services customarily furnished as part of such service. The term third party payer means an entity that is, by statute, contract, or agreement, legally responsible for payment of a claim for a health care item or service. The amendments made by subsection (a) shall apply beginning January 1, 2025. Nothing in the amendments made by this section may be construed as affecting the applicability of the regulations codified at part 180 of title 45, Code of Federal Regulations, before January 1, 2025. The provisions of this Act shall not supersede any provision of State law that establishes, implements, or continues in effect any requirement or prohibition related to health care price transparency, except to the extent that such requirement or prohibition prevents the application of a requirement or prohibition of this Act. (e)Standard hospital charges(1)In general(A)Disclosure of standard chargesFor purposes of paragraph (1), the price transparency requirement described in this paragraph is, with respect to a hospital, that such hospital, in accordance with a method and format established by the Secretary under subparagraph (C), compile and make public (without subscription and free of charge) for each month—(i)all of the hospital’s standard charges (including the information described in subparagraph (B)) for each item and service furnished by such hospital; and(ii)information in a consumer-friendly format (as specified by the Secretary)—(I)on the hospital’s prices (including the information described in subparagraph (B)) for as many of the Centers for Medicare & Medicaid Services-specified shoppable services that are furnished by the hospital, and as many additional hospital-selected shoppable services (or all such additional services, if such hospital furnishes fewer than 300 shoppable services) as may be necessary for a combined total of at least 300 shoppable services through December 31, 2024, after which the hospital’s prices shall include all shoppable services; and(II)that includes, with respect to each Centers for Medicare & Medicaid Services-specified shoppable service that is not furnished by the hospital, an indication that such service is not so furnished.(B)Standard charges describedFor purposes of subparagraph (A), the information described in this subparagraph is, with respect to standard charges and prices, as applicable, made public by a hospital, the following:(i)A plain language description of each item or service, accompanied by any applicable billing codes, including modifiers, using commonly recognized billing code sets, including the Current Procedural Terminology code, the Healthcare Common Procedure Coding System code, the diagnosis-related group, the National Drug Code, and other nationally recognized identifier.(ii)The gross charge, as applicable, expressed as a dollar amount, for each such item or service, when provided in, as applicable, the inpatient setting and outpatient department setting.(iii)The discounted cash price, as applicable, expressed as a dollar amount, for each such item or service when provided in, as applicable, the inpatient setting and outpatient department setting (or, in the case no discounted cash price is available for an item or service, the minimum cash price accepted by the hospital from self-pay individuals for such item or service, expressed as a dollar amount, as well as, with respect to prices made public pursuant to subparagraph (A)(ii), a link to a consumer-friendly document that clearly explains the hospital’s charity care policy). The hospital shall accept the discounted cash price as payment in full from any patient that chooses to pay in cash without regard to the patient’s coverage.(iv)The payer-specific negotiated charges, expressed as a dollar amount and clearly associated with the name of the applicable third party payer and name of each plan, that apply to each such item or service when provided in, as applicable, the inpatient setting and outpatient department setting. If the charges are based on an algorithm, percentage of another amount, or other formula or criteria, the hospital also shall disclose such algorithm, percentage, formula, or criteria as set forth in its contract and any other terms, schedules, exhibits, data, or other information referenced in any such contract as shall be required to determine and disclose the negotiated charge.(v)The de-identified maximum and minimum negotiated charges, as applicable, for each such item or service, expressed as a non-zero dollar amount.(vi)Any other additional information the Secretary may require for the purpose of improving the accuracy of, or enabling consumers to easily understand and compare, standard charges and prices for an item or service, except information that is duplicative of any other reporting requirement under this subsection. In the case of standard charges and prices for an item or service included as part of a bundled, per diem, episodic, or other similar arrangement, the information described in this subparagraph shall be made available as determined appropriate by the Secretary.(C)Uniform method and formatNot later than January 1, 2025, the Secretary shall establish a standard, uniform method and format for hospitals to use in compiling and making public standard charges pursuant to subparagraph (A)(i) and a standard, uniform method and format for such hospitals to use in compiling and making public prices pursuant to subparagraph (A)(ii). Such methods and formats—(i)shall, in the case of such method and format for making public standard charges pursuant to subparagraph (A)(i), ensure that such charges are made available in a machine-readable spreadsheet format;(ii)may be similar to any template made available by the Centers for Medicare & Medicaid Services as of the date of the enactment of this subparagraph;(iii)shall meet such standards as determined appropriate by the Secretary in order to ensure the accessibility and usability of such charges and prices; and(iv)shall be updated as determined appropriate by the Secretary, in consultation with stakeholders.(2)No deemed complianceThe availability of a price estimator tool shall not be considered to deem compliance with or otherwise vitiate the requirements of paragraph (2)(A)(ii) or any other requirements of this section. Furthermore, the use of an estimator tool shall not be used for purposes of compliance with any provisions in this Section.(3)Monitoring complianceThe Secretary shall, in consultation with the Inspector General of the Department of Health and Human Services, establish a process to monitor compliance with this subsection. Such process shall ensure that each hospital’s compliance with this subsection is reviewed not less frequently than once every year.(4)AttestationA senior official from each hospital (the Chief Executive Officer, Chief Financial Officer, or an official of equivalent seniority) shall attest to the accuracy and completeness of the disclosures made in accordance with the hospital price transparency requirements set forth in this regulation. Such attestation shall be deemed to be material to payment from the Federal Government to the hospital.(5)Enforcement(A)In generalIn the case of a hospital that fails to comply with the requirements of this subsection, not later than 30 days after the date on which the Secretary determines such failure exists, the Secretary shall submit to such hospital a notification of such determination, which shall include a request for a corrective action plan to comply with such requirements.(B)Civil monetary penalty(i)In generalIn addition to any other enforcement actions or penalties that may apply under another provision of law, a hospital that has received a request for a corrective action plan under subparagraph (A) and fails to comply with the requirements of this subsection by the date that is 45 days after such request is made shall be subject to a civil monetary penalty of an amount specified by the Secretary for each day (beginning with the day on which the Secretary first determined that such hospital was not complying with such requirements) during which such failure was ongoing. Such amount shall not exceed—(I)in the case of a hospital with 30 or fewer beds, $300 per day;(II)in the case of a hospital with more than 30 beds but fewer than 101 beds, $10 per bed per day (or, in the case of such a hospital that has been noncompliant with such requirements for a 1-year period or longer, beginning with the first day following such 1-year period, $12.50 per bed per day);(III)in the case of a hospital with more than 100 beds but fewer than 301 beds, $15 per bed per day (or, in the case of such a hospital that has been noncompliant with such requirements for a 1-year period or longer, beginning with the first day following such 1-year period, $17.50 per bed per day);(IV)in the case of a hospital with more than 300 beds but fewer than 501 beds, $20 per bed per day (or, in the case of such a hospital that has been noncompliant with such requirements for a 1-year period or longer, beginning with the first day following such 1-year period, $25 per bed per day); and(V)in the case of a hospital with more than 500 beds, $25 per bed per day (or, in the case of such a hospital that has been noncompliant with such requirements for a 1-year period or longer, beginning with the first day following such 1-year period, $35 per bed per day).(ii)Increase authorityIn applying this subparagraph with respect to violations occurring in 2027 or a subsequent year, the Secretary may through notice and comment rulemaking increase—(I)the limitation on the per day amount of any penalty applicable to a hospital under clause (i)(I);(II)the limitations on the per bed per day amount of any penalty applicable under any of subclauses (II) through (V) of clause (i); and(III)the limitation on the increase of any penalty applied under clause (iii) pursuant to the amounts specified in subclause (II) of such clause.(iii)Persistent noncompliance(I)In generalIn the case of a hospital that the Secretary has determined to be knowingly and willfully noncompliant with the provisions of this subsection two or more times during a 1-year period, the Secretary may increase any penalty otherwise applicable under this subparagraph by the amount specified in subclause (II) with respect to such hospital and may require such hospital to complete such additional corrective actions plans as the Secretary may specify.(II)Specified amountFor purposes of subclause (I), the amount specified in this subclause is, with respect to a hospital—(aa)with more than 30 beds but fewer than 101 beds, an amount that is not less than $500,000 and not more than $1,000,000;(bb)with more than 100 beds but fewer than 301 beds, an amount that is greater than $1,000,000 and not more than $2,000,000;(cc)with more than 300 beds but fewer than 501 beds, an amount that is greater than $2,000,000 and not more than $4,000,000; and(dd)with more than 500 beds, and amount that is not less than $5,000,000 and not more than $10,000,000.(iv)Provision of technical assistanceThe Secretary may, to the extent practicable, provide technical assistance relating to compliance with the provisions of this section to hospitals requesting such assistance.(v)Application of certain provisionsThe provisions of section 1128A (other than subsections (a) and (b) of such section) shall apply to a civil monetary penalty imposed under this subparagraph in the same manner as such provisions apply to a civil monetary penalty imposed under subsection (a) of such section.(C)No waiverThe Secretary shall not grant or extend any waiver, delay, tolling, or other mitigation of a civil monetary penalty for violation of this subsection.(6)DefinitionsFor purposes of this subsection:(A)Discounted cash priceThe term discounted cash price means the minimum charge that the hospital accepts from an individual who pays cash, or cash equivalent, for a hospital-furnished item or service.(B)Gross chargeThe term gross charge means the charge for an individual item or service that is reflected on a hospital’s chargemaster, absent any discounts.(C)HospitalThe term hospital means a hospital (as defined in section 1861(e) of the Social Security Act), a critical access hospital (as defined in section 1861(mmm)(1) of the Social Security Act), or a rural emergency hospital (as defined in section 1861(kkk) of the Social Security Act), together with any parent, subsidiary, or other affiliated provider or supplier of health care items and services without regard to whether such parent, subsidiary, or other affiliated provider or supplier operates under separate licensure, certification, or designation.(D)Payer-specific negotiated chargeThe term payer-specific negotiated charge means the charge that a hospital has negotiated with a third party payer for an item or service.(E)Shoppable serviceThe term shoppable service means a service that can be scheduled by a health care consumer in advance and includes all ancillary items and services customarily furnished as part of such service.(F)Third party payerThe term third party payer means an entity that is, by statute, contract, or agreement, legally responsible for payment of a claim for a health care item or service..

7. Increasing group health plan access to health data Paragraph (2) of section 408(b) of the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. 1108(b)) is amended by adding at the end the following new subparagraphs: No contract or arrangement for services between a group health plan and any other entity, including a health care provider (including a health care facility), network or association of providers, service provider offering access to a network of providers, third-party administrator, or pharmacy benefit manager (collectively, Covered Service Providers), is reasonable within the meaning of this paragraph unless such contract or arrangement— allows the responsible group health plan access to all claims and encounter information, and any documentation supporting claim payments, including, but not limited to, medical records and policy documents, or data described in section 724(a)(1)(B) to— enable such entity to comply with the terms of the plan and any applicable law; and determine the accuracy or reasonableness of payment; and does not— unreasonably limit or delay access to such information or data; limit the volume of claims and encounter information or data that the group health plan may access during an audit; limit the disclosure of pricing terms for value-based payment arrangements or capitated payment arrangements, including— payment calculations and formulas; quality measures; contract terms; payment amounts; measurement periods for all incentives; and other payment methodologies used by an entity, including a health care provider (including a health care facility), network or association of providers, service provider offering access to a network of providers, third-party administrator, or pharmacy benefit manager; limit the disclosure of overpayments and overpayment recovery terms; limit the right of the group health plan to select an auditor or define audit scope or frequency; otherwise limit or unduly delay the group health plan from accessing claims and encounter information or data in a daily batch. limit the disclosure of fees charged to the group health plan related to plan administration and claims processing, including renegotiation fees, access fees, repricing fees, or enhanced review fees; limit the right of the group health plan to request action on any suspect claim payments; or limit public disclosure of de-identified or aggregate information. Covered Service Providers shall provide information under this paragraph in a manner consistent with the privacy and security regulations promulgated under the Health Insurance Portability and Accountability Act (HIPAA). This subparagraph shall not be read to abridge or limit the disclosure requirements under this paragraph or to impose additional privacy or security requirements on Covered Service Providers or plan sponsors. A group health plan receiving information or data under this paragraph may disclose such information only to the entity from which the information or data was received, the group health plan or plan sponsor to which the information or data pertains, or to that entity’s business associates as defined in section 160.103 of title 45, Code of Federal Regulations, or as otherwise permitted by the HIPAA Privacy Rule (45 CFR parts 160 and 164, subparts A and E). Information made available under this section shall conform to the following standards: Institutional, professional, and dental claims received from a healthcare provider shall be made available to the group health plan as ASC X12N 837 files. The files shall be unmodified copies of the files sent from the provider. In the event that paper claims are sent by the provider, they shall be converted to the ASC X12N 837 electronic format. Files shall be accessible to the plan at no cost to the group health plan. All claim payment (or EFT, electronic funds transfer) and electronic remittance advice (ERA) notices sent by a Covered Service Provider shall be made available to the group health plan as ASC X12N 835 files. The files shall be unmodified copies of the files sent by the Covered Service Provider to the healthcare provider. Files shall be accessible at no cost to the group health plan. The contractual terms containing calculation formulae, pricing methodologies, and other information used to determine the dollar value of reimbursement. All non-claim costs shall be itemized and made available to the group health plan in real time through a web-based portal, through an API, and through a downloadable CSV file. Subsection (c) of section 502 of such Act (29 U.S.C. 1132) is amended by adding at the end the following new paragraph: ‘‘(13) In the case of an agreement between a group health plan and a health care provider (including a health care facility), network or association of providers, service provider offering access to a network of providers, third-party administrator, or pharmacy benefit manager, that violates the provisions of section 724, the Secretary may assess a civil penalty against such provider, network or association, service provider offering access to a network of providers, third-party administrator, pharmacy benefit manager, or other service provider in the amount of $10,000 for each day during which such violation continues. Such penalty shall be in addition to other penalties as may be prescribed by law. Paragraph (6) of section 502(a) of such Act is amended by striking or (9) and inserting (9), or (13) . Section 410 of such Act is amended by adding at the end the following: Any provision in an agreement or instrument shall be void as against public policy if such provision— unduly delays or limits a group health plan from accessing the claims and encounter information or data described in section 724(a)(1)(B); or violates the requirements of section 408(b)(2)(C). Clause (i) of section 408(b)(2)(B) of such Act is amended by striking this clause and inserting this paragraph. Section 724(a)(3) of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1185m(a)(3)) is amended to read as follows: Subject to subparagraph (C), the group health plan or health insurance issuer offering group health insurance coverage shall annually submit to the Secretary an attestation that such plan or issuer of such coverage is in compliance with the requirements of this subsection. Such attestation shall also include a statement verifying that— the information or data described under subparagraphs (A) and (B) of paragraph (1) is available upon request and provided to the group health plan, the plan administrator, or the issuer in a timely manner; and there are no terms in the agreement under such paragraph (1) that directly or indirectly restrict or unduly delay a group health plan, the plan administrator, or the issuer from auditing, reviewing, or otherwise accessing such information, except as permitted under section 408(b)(2)(C). Subject to clause (ii), a group health plan or issuer offering group health insurance coverage may not enter into an agreement with a third-party administrator or other service provider to submit the attestation required under subparagraph (A). In the case of a group health plan or issuer offering group health insurance coverage that is unable to obtain the information or data needed to submit the attestation required under subparagraph (A), such plan or issuer may submit a written statement in lieu of such attestation that includes— an explanation of why such plan or issuer was unsuccessful in obtaining such information or data, including whether such plan or issuer was limited or prevented from auditing, reviewing, or otherwise accessing such information or data; a description of the efforts made by the group health plan to remove any gag clause provisions from the agreement under paragraph (1); and a description of any response by the third-party administrator or other service provider with respect to efforts to comply with the attestation requirement under subparagraph (A). The amendments made by subsections (a) and (b) shall apply with respect to a plan beginning with the first plan year that begins on or after the date that is 1 year after the date of enactment of this Act. (C)No contract or arrangement for services between a group health plan and any other entity, including a health care provider (including a health care facility), network or association of providers, service provider offering access to a network of providers, third-party administrator, or pharmacy benefit manager (collectively, Covered Service Providers), is reasonable within the meaning of this paragraph unless such contract or arrangement—(i)allows the responsible group health plan access to all claims and encounter information, and any documentation supporting claim payments, including, but not limited to, medical records and policy documents, or data described in section 724(a)(1)(B) to—(I)enable such entity to comply with the terms of the plan and any applicable law; and(II)determine the accuracy or reasonableness of payment; and(ii)does not—(I)unreasonably limit or delay access to such information or data;(II)limit the volume of claims and encounter information or data that the group health plan may access during an audit;(III)limit the disclosure of pricing terms for value-based payment arrangements or capitated payment arrangements, including—(aa)payment calculations and formulas;(bb)quality measures;(cc)contract terms;(dd)payment amounts;(ee)measurement periods for all incentives; and(ff)other payment methodologies used by an entity, including a health care provider (including a health care facility), network or association of providers, service provider offering access to a network of providers, third-party administrator, or pharmacy benefit manager;(IV)limit the disclosure of overpayments and overpayment recovery terms;(V)limit the right of the group health plan to select an auditor or define audit scope or frequency;(VI)otherwise limit or unduly delay the group health plan from accessing claims and encounter information or data in a daily batch.(VII)limit the disclosure of fees charged to the group health plan related to plan administration and claims processing, including renegotiation fees, access fees, repricing fees, or enhanced review fees;(VIII)limit the right of the group health plan to request action on any suspect claim payments; or(IX)limit public disclosure of de-identified or aggregate information.(D)Privacy requirementsCovered Service Providers shall provide information under this paragraph in a manner consistent with the privacy and security regulations promulgated under the Health Insurance Portability and Accountability Act (HIPAA). This subparagraph shall not be read to abridge or limit the disclosure requirements under this paragraph or to impose additional privacy or security requirements on Covered Service Providers or plan sponsors. (E)Disclosure and redisclosure; limitation to business associatesA group health plan receiving information or data under this paragraph may disclose such information only to the entity from which the information or data was received, the group health plan or plan sponsor to which the information or data pertains, or to that entity’s business associates as defined in section 160.103 of title 45, Code of Federal Regulations, or as otherwise permitted by the HIPAA Privacy Rule (45 CFR parts 160 and 164, subparts A and E).(F)Data standardsInformation made available under this section shall conform to the following standards:(i)Institutional, professional, and dental claims received from a healthcare provider shall be made available to the group health plan as ASC X12N 837 files. The files shall be unmodified copies of the files sent from the provider. In the event that paper claims are sent by the provider, they shall be converted to the ASC X12N 837 electronic format. Files shall be accessible to the plan at no cost to the group health plan.(ii)All claim payment (or EFT, electronic funds transfer) and electronic remittance advice (ERA) notices sent by a Covered Service Provider shall be made available to the group health plan as ASC X12N 835 files. The files shall be unmodified copies of the files sent by the Covered Service Provider to the healthcare provider. Files shall be accessible at no cost to the group health plan.(iii)The contractual terms containing calculation formulae, pricing methodologies, and other information used to determine the dollar value of reimbursement.(iv)All non-claim costs shall be itemized and made available to the group health plan in real time through a web-based portal, through an API, and through a downloadable CSV file.. (c)Any provision in an agreement or instrument shall be void as against public policy if such provision—(1)unduly delays or limits a group health plan from accessing the claims and encounter information or data described in section 724(a)(1)(B); or(2)violates the requirements of section 408(b)(2)(C).. (3)Attestation(A)In generalSubject to subparagraph (C), the group health plan or health insurance issuer offering group health insurance coverage shall annually submit to the Secretary an attestation that such plan or issuer of such coverage is in compliance with the requirements of this subsection. Such attestation shall also include a statement verifying that—(i)the information or data described under subparagraphs (A) and (B) of paragraph (1) is available upon request and provided to the group health plan, the plan administrator, or the issuer in a timely manner; and(ii)there are no terms in the agreement under such paragraph (1) that directly or indirectly restrict or unduly delay a group health plan, the plan administrator, or the issuer from auditing, reviewing, or otherwise accessing such information, except as permitted under section 408(b)(2)(C).(B)Limitation on submissionSubject to clause (ii), a group health plan or issuer offering group health insurance coverage may not enter into an agreement with a third-party administrator or other service provider to submit the attestation required under subparagraph (A).(C)ExceptionIn the case of a group health plan or issuer offering group health insurance coverage that is unable to obtain the information or data needed to submit the attestation required under subparagraph (A), such plan or issuer may submit a written statement in lieu of such attestation that includes—(i)an explanation of why such plan or issuer was unsuccessful in obtaining such information or data, including whether such plan or issuer was limited or prevented from auditing, reviewing, or otherwise accessing such information or data;(ii)a description of the efforts made by the group health plan to remove any gag clause provisions from the agreement under paragraph (1); and(iii)a description of any response by the third-party administrator or other service provider with respect to efforts to comply with the attestation requirement under subparagraph (A)..