109 HR 2259 IH: Patients’ Bill of Rights Act of 2005 U.S. House of Representatives 2005-05-11 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
I 109th CONGRESS 1st Session H. R. 2259 IN THE HOUSE OF REPRESENTATIVES May 11, 2005 Mr. Dingell (for himself, Ms. Pelosi, Mr. Hoyer, Mr. Berry, Mr. Andrews, Mr. Rangel, Mr. George Miller of California, Mr. Brown of Ohio, Mr. Stark, Mr. Waxman, Mr. Markey, Mrs. Capps, Mr. Doyle, Mr. Rush, Ms. Solis, Mr. Davis of Florida, Mr. Gene Green of Texas, Ms. Schakowsky, Mr. Towns, Mr. Strickland, Mr. Pallone, Mr. Engel, Mr. Boucher, Ms. Eshoo, Ms. DeGette, Ms. McCollum of Minnesota, Mr. Tierney, Mr. Owens, Mrs. McCarthy, Mr. Holt, Mr. Kildee, Mr. Grijalva, Ms. Woolsey, Mrs. Davis of California, Mr. Nadler, Mr. Van Hollen, Mr. McNulty, Mr. Cummings, Mr. Schiff, Mr. Hinchey, Ms. Roybal-Allard, Mr. Honda, Mr. Abercrombie, Mr. Farr, Mr. Wexler, Mr. Brady of Pennsylvania, Mr. McDermott, Mr. McGovern, Mr. Moore of Kansas, Mr. Dicks, Mr. Clay, Mr. Kucinich, and Mr. Hastings of Florida) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committees on Education and the Workforce and Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to protect consumers in managed care plans and other health coverage.
1.
Short title; table of contents
(a)
Short title
This Act may be cited as the Patients’ Bill of Rights Act of 2005. (b)
Table of contents
The table of contents of this Act is as follows: Sec. 1. Short title; table of contents Title I—Improving managed care Subtitle A—Utilization Review; Claims; and Internal and External Appeals Sec. 101. Utilization review activities Sec. 102. Procedures for initial claims for benefits and prior authorization determinations Sec. 103. Internal appeals of claims denials Sec. 104. Independent external appeals procedures Sec. 105. Health Care Consumer Assistance Fund Subtitle B—Access to Care Sec. 111. Consumer choice option Sec. 112. Choice of health care professional Sec. 113. Access to emergency care Sec. 114. Timely access to specialists Sec. 115. Patient access to obstetrical and gynecological care Sec. 116. Access to pediatric care Sec. 117. Continuity of care Sec. 118. Access to needed prescription drugs Sec. 119. Coverage for individuals participating in approved clinical trials Sec. 120. Required coverage for minimum hospital stay for mastectomies and lymph node dissections for the treatment of breast cancer and coverage for secondary consultations Subtitle C—Access to Information Sec. 121. Patient access to information Subtitle D—Protecting the Doctor-Patient Relationship Sec. 131. Prohibition of interference with certain medical communications Sec. 132. Prohibition of discrimination against providers based on licensure Sec. 133. Prohibition against improper incentive arrangements Sec. 134. Payment of claims Sec. 135. Protection for patient advocacy Subtitle E—Definitions Sec. 151. Definitions Sec. 152. Preemption; State flexibility; construction Sec. 153. Exclusions Sec. 154. Treatment of excepted benefits Sec. 155. Regulations Sec. 156. Incorporation into plan or coverage documents Sec. 157. Preservation of protections Title II—Application of quality care standards to group health plans and health insurance coverage under the Public Health Service Act Sec. 201. Application to group health plans and group health insurance coverage Sec. 202. Application to individual health insurance coverage Sec. 203. Cooperation between Federal and State authorities Title III—Application of patient protection standards to Federal health insurance programs Sec. 301. Application of patient protection standards to Federal health insurance programs Title IV—Amendments to the Employee Retirement Income Security Act of 1974 Sec. 401. Application of patient protection standards to group health plans and group health insurance coverage under the Employee Retirement Income Security Act of 1974 Sec. 402. Availability of civil remedies Sec. 403. Cooperation between Federal and State authorities Title V—Amendments to the Internal Revenue Code of 1986 Subtitle A—Application of Patient Protection Provisions Sec. 501. Application to group health plans under the Internal Revenue Code of 1986 Sec. 502. Conforming enforcement for women’s health and cancer rights Subtitle B—Health Care Coverage Access Tax Incentives Sec. 511. Credit for health insurance expenses of small businesses Sec. 512. Certain grants by private foundations to qualified health benefit purchasing coalitions Sec. 513. State grant program for market innovation Sec. 514. Grant program to facilitate health benefits information for small employers Sec. 515. State grant program for market innovation Title VI—Effective dates; coordination in implementation Sec. 601. Effective dates Sec. 602. Coordination in implementation Sec. 603. Severability Title VII—Miscellaneous provisions Sec. 701. No impact on Social Security Trust Fund
<enum>I</enum><header>Improving managed care</header> <subtitle id="HC3F542D718BC4C84BF78883F003B22DC"><enum>A</enum><header>Utilization review; claims; and internal and external appeals</header> <section id="H982E52F4C42D44FEAB1C50E650BF52B4"><enum>101.</enum><header>Utilization review activities</header> <subsection id="HABC9AC09135C472993D2D6FE58E8DC8C"><enum>(a)</enum><header>Compliance with requirements</header> <paragraph id="H69F7E9D75BB6432283B98FD03777554C"><enum>(1)</enum><header>In general</header><text>A group health plan, and a health insurance issuer that provides health insurance coverage, shall conduct utilization review activities in connection with the provision of benefits under such plan or coverage only in accordance with a utilization review program that meets the requirements of this section and section 102.</text></paragraph> <paragraph id="HA85E30078BD645E986D55EE9F0755B6C"><enum>(2)</enum><header>Use of outside agents</header><text>Nothing in this section shall be construed as preventing a group health plan or health insurance issuer from arranging through a contract or otherwise for persons or entities to conduct utilization review activities on behalf of the plan or issuer, so long as such activities are conducted in accordance with a utilization review program that meets the requirements of this section.</text></paragraph> <paragraph id="H794A8FE4BA52494DB4AD1556E688DAD7"><enum>(3)</enum><header>Utilization review defined</header><text>For purposes of this section, the terms <term>utilization review</term> and <term>utilization review activities</term> mean procedures used to monitor or evaluate the use or coverage, clinical necessity, appropriateness, efficacy, or efficiency of health care services, procedures or settings, and includes prospective review, concurrent review, second opinions, case management, discharge planning, or retrospective review.</text></paragraph></subsection> <subsection id="H30826CA9264C420AAA677336DA43AA99"><enum>(b)</enum><header>Written policies and criteria</header> <paragraph id="H2D51CBA25BE6414EA6F0DD00C79FF16"><enum>(1)</enum><header>Written policies</header><text>A utilization review program shall be conducted consistent with written policies and procedures that govern all aspects of the program.</text></paragraph> <paragraph id="H9BED53898A2C44499EB0949B056179A2"><enum>(2)</enum><header>Use of written criteria</header> <subparagraph id="H734282EEE4F04853990016C572E91C51"><enum>(A)</enum><header>In general</header><text>Such a program shall utilize written clinical review criteria developed with input from a range of appropriate actively practicing health care professionals, as determined by the plan, pursuant to the program. Such criteria shall include written clinical review criteria that are based on valid clinical evidence where available and that are directed specifically at meeting the needs of at-risk populations and covered individuals with chronic conditions or severe illnesses, including gender-specific criteria and pediatric-specific criteria where available and appropriate.</text></subparagraph> <subparagraph id="H088F24C113F4413DA3DB126556B90340"><enum>(B)</enum><header>Continuing use of standards in retrospective review</header><text>If a health care service has been specifically pre-authorized or approved for a participant, beneficiary, or enrollee under such a program, the program shall not, pursuant to retrospective review, revise or modify the specific standards, criteria, or procedures used for the utilization review for procedures, treatment, and services delivered to the enrollee during the same course of treatment.</text></subparagraph> <subparagraph id="H6DDE83478C584D2BAC9068002EB93364"><enum>(C)</enum><header>Review of sample of claims denials</header><text>Such a program shall provide for a periodic evaluation of the clinical appropriateness of at least a sample of denials of claims for benefits.</text></subparagraph></paragraph></subsection> <subsection id="H68952AB4BB6B4523B4F80000B95644B0"><enum>(c)</enum><header>Conduct of program activities</header> <paragraph id="HD2042E4E5D2A4DD585F614E8FE006878"><enum>(1)</enum><header>Administration by health care professionals</header><text>A utilization review program shall be administered by qualified health care professionals who shall oversee review decisions.</text></paragraph> <paragraph id="HD403A83B2BE645F3818800364EF100DF"><enum>(2)</enum><header>Use of qualified, independent personnel</header> <subparagraph id="H5909271473144FB700FBF0C4A258D600"><enum>(A)</enum><header>In general</header><text>A utilization review program shall provide for the conduct of utilization review activities only through personnel who are qualified and have received appropriate training in the conduct of such activities under the program.</text></subparagraph> <subparagraph id="HF7B224A544694C648500758CE7F3F467"><enum>(B)</enum><header>Prohibition of contingent compensation arrangements</header><text>Such a program shall not, with respect to utilization review activities, permit or provide compensation or anything of value to its employees, agents, or contractors in a manner that encourages denials of claims for benefits.</text></subparagraph> <subparagraph id="HE55667D52E2C43BAA062CD158FD26CAB"><enum>(C)</enum><header>Prohibition of conflicts</header><text>Such a program shall not permit a health care professional who is providing health care services to an individual to perform utilization review activities in connection with the health care services being provided to the individual.</text></subparagraph></paragraph> <paragraph id="H075F3CABE6034644A50035C6ADFC5EC2"><enum>(3)</enum><header>Accessibility of review</header><text>Such a program shall provide that appropriate personnel performing utilization review activities under the program, including the utilization review administrator, are reasonably accessible by toll-free telephone during normal business hours to discuss patient care and allow response to telephone requests, and that appropriate provision is made to receive and respond promptly to calls received during other hours.</text></paragraph> <paragraph id="H6057158F1EB74A58B0B28D92A555497E"><enum>(4)</enum><header>Limits on frequency</header><text>Such a program shall not provide for the performance of utilization review activities with respect to a class of services furnished to an individual more frequently than is reasonably required to assess whether the services under review are medically necessary and appropriate.</text></paragraph></subsection></section> <section id="H931BFFCDC3AC41748346FAF4483DA01"><enum>102.</enum><header>Procedures for initial claims for benefits and prior authorization determinations</header> <subsection id="H4A09FB1BC09F4D459E83D7E601812DA"><enum>(a)</enum><header>Procedures of initial claims for benefits</header> <paragraph id="HA651A7D1055A4BBAB300858455ECF5F"><enum>(1)</enum><header>In general</header><text>A group health plan, and a health insurance issuer offering health insurance coverage, shall—</text> <subparagraph id="HF57CDC88802448999415367C0597B61B"><enum>(A)</enum><text>make a determination on an initial claim for benefits by a participant, beneficiary, or enrollee (or authorized representative) regarding payment or coverage for items or services under the terms and conditions of the plan or coverage involved, including any cost-sharing amount that the participant, beneficiary, or enrollee is required to pay with respect to such claim for benefits; and</text></subparagraph> <subparagraph id="H0F0164D4F4C74DF19593148EE8A53929"><enum>(B)</enum><text>notify a participant, beneficiary, or enrollee (or authorized representative) and the treating health care professional involved regarding a determination on an initial claim for benefits made under the terms and conditions of the plan or coverage, including any cost-sharing amounts that the participant, beneficiary, or enrollee may be required to make with respect to such claim for benefits, and of the right of the participant, beneficiary, or enrollee to an internal appeal under section 103.</text></subparagraph></paragraph> <paragraph id="H7F99F854A46A4C478371C3BDC047CA11"><enum>(2)</enum><header>Access to information</header> <subparagraph id="HA7FA78149458415BAF538D33BA935FB9"><enum>(A)</enum><header>Timely provision of necessary information</header><text>With respect to an initial claim for benefits, the participant, beneficiary, or enrollee (or authorized representative) and the treating health care professional (if any) shall provide the plan or issuer with access to information requested by the plan or issuer that is necessary to make a determination relating to the claim. Such access shall be provided not later than 5 days after the date on which the request for information is received, or, in a case described in subparagraph (B) or (C) of subsection (b)(1), by such earlier time as may be necessary to comply with the applicable timeline under such subparagraph.</text></subparagraph> <subparagraph id="HB4A3E271A5E14F4FB4593E119528A7C9"><enum>(B)</enum><header>Limited effect of failure on plan or issuer’s obligations</header><text>Failure of the participant, beneficiary, or enrollee to comply with the requirements of subparagraph (A) shall not remove the obligation of the plan or issuer to make a decision in accordance with the medical exigencies of the case and as soon as possible, based on the available information, and failure to comply with the time limit established by this paragraph shall not remove the obligation of the plan or issuer to comply with the requirements of this section.</text></subparagraph></paragraph> <paragraph id="HED318C53B729409DB2C04F4F9C515DDA"><enum>(3)</enum><header>Oral requests</header><text>In the case of a claim for benefits involving an expedited or concurrent determination, a participant, beneficiary, or enrollee (or authorized representative) may make an initial claim for benefits orally, but a group health plan, or health insurance issuer offering health insurance coverage, may require that the participant, beneficiary, or enrollee (or authorized representative) provide written confirmation of such request in a timely manner on a form provided by the plan or issuer. In the case of such an oral request for benefits, the making of the request (and the timing of such request) shall be treated as the making at that time of a claim for such benefits without regard to whether and when a written confirmation of such request is made.</text></paragraph></subsection> <subsection id="H866BE66C5C284AEABA6FABAB6C66D974"><enum>(b)</enum><header>Timeline for making determinations</header> <paragraph id="HEC8349FAC5894DB693472100D702C90"><enum>(1)</enum><header>Prior authorization determination</header> <subparagraph id="H3D20163BEBEB46939FECB9B1B984016"><enum>(A)</enum><header>In general</header><text>A group health plan, and a health insurance issuer offering health insurance coverage, shall make a prior authorization determination on a claim for benefits (whether oral or written) in accordance with the medical exigencies of the case and as soon as possible, but in no case later than 14 days from the date on which the plan or issuer receives information that is reasonably necessary to enable the plan or issuer to make a determination on the request for prior authorization and in no case later than 28 days after the date of the claim for benefits is received.</text></subparagraph> <subparagraph id="H57C09D2C100A4F6A92AF005E01AA11F0"><enum>(B)</enum><header>Expedited determination</header><text>Notwithstanding subparagraph (A), a group health plan, and a health insurance issuer offering health insurance coverage, shall expedite a prior authorization determination on a claim for benefits described in such subparagraph when a request for such an expedited determination is made by a participant, beneficiary, or enrollee (or authorized representative) at any time during the process for making a determination and a health care professional certifies, with the request, that a determination under the procedures described in subparagraph (A) would seriously jeopardize the life or health of the participant, beneficiary, or enrollee or the ability of the participant, beneficiary, or enrollee to maintain or regain maximum function. Such determination shall be made in accordance with the medical exigencies of the case and as soon as possible, but in no case later than 72 hours after the time the request is received by the plan or issuer under this subparagraph.</text></subparagraph> <subparagraph id="HFC99820F23F84026AB4C2F28A3B1EDF6"><enum>(C)</enum><header>Ongoing care</header> <clause id="HF09E12E730AF4F43A84660E8C4653D0"><enum>(i)</enum><header>Concurrent review</header> <subclause id="HE8E6947B0AA543DA95E773CBCD662971"><enum>(I)</enum><header>In general</header><text>Subject to clause (ii), in the case of a concurrent review of ongoing care (including hospitalization), which results in a termination or reduction of such care, the plan or issuer must provide by telephone and in printed form notice of the concurrent review determination to the individual or the individual’s designee and the individual’s health care provider in accordance with the medical exigencies of the case and as soon as possible, with sufficient time prior to the termination or reduction to allow for an appeal under section 103(b)(3) to be completed before the termination or reduction takes effect.</text></subclause> <subclause id="HADB938BFE12349989B43C8F604A771CE"><enum>(II)</enum><header>Contents of notice</header><text>Such notice shall include, with respect to ongoing health care items and services, the number of ongoing services approved, the new total of approved services, the date of onset of services, and the next review date, if any, as well as a statement of the individual’s rights to further appeal.</text></subclause></clause> <clause id="H8913FA2F12634896AFCF00AFFC89CF"><enum>(ii)</enum><header>Rule of construction</header><text>Clause (i) shall not be construed as requiring plans or issuers to provide coverage of care that would exceed the coverage limitations for such care.</text></clause></subparagraph></paragraph> <paragraph id="H0F4B71A1FC6A4C448B2CC9AA0A941E8"><enum>(2)</enum><header>Retrospective determination</header><text>A group health plan, and a health insurance issuer offering health insurance coverage, shall make a retrospective determination on a claim for benefits in accordance with the medical exigencies of the case and as soon as possible, but not later than 30 days after the date on which the plan or issuer receives information that is reasonably necessary to enable the plan or issuer to make a determination on the claim, or, if earlier, 60 days after the date of receipt of the claim for benefits.</text></paragraph></subsection> <subsection id="H3B9B2D406D2F4BFCB4D846688B246782"><enum>(c)</enum><header>Notice of a denial of a claim for benefits</header><text>Written notice of a denial made under an initial claim for benefits shall be issued to the participant, beneficiary, or enrollee (or authorized representative) and the treating health care professional in accordance with the medical exigencies of the case and as soon as possible, but in no case later than 2 days after the date of the determination (or, in the case described in subparagraph (B) or (C) of subsection (b)(1), within the 72-hour or applicable period referred to in such subparagraph).</text></subsection> <subsection id="HF76DDA5432834702BF8F32422300D2F8"><enum>(d)</enum><header>Requirements of notice of determinations</header><text>The written notice of a denial of a claim for benefits determination under subsection (c) shall be provided in printed form and written in a manner calculated to be understood by the participant, beneficiary, or enrollee and shall include—</text> <paragraph id="H902E24E711884A2B8839BE67E1CBDB36"><enum>(1)</enum><text>the specific reasons for the determination (including a summary of the clinical or scientific evidence used in making the determination);</text></paragraph> <paragraph id="H587D367DB36A4B6B9E067DEAFE34EE8F"><enum>(2)</enum><text>the procedures for obtaining additional information concerning the determination; and</text></paragraph> <paragraph id="H36B40B924C9F4BAF8E4C82D571F7E53"><enum>(3)</enum><text>notification of the right to appeal the determination and instructions on how to initiate an appeal in accordance with section 103.</text></paragraph></subsection> <subsection id="H02A0FE51E1E044848BC9D2561760176B"><enum>(e)</enum><header>Definitions</header><text>For purposes of this part:</text> <paragraph id="HF508D54D0F2B4BECB028B5F0006BDB05"><enum>(1)</enum><header>Authorized representative</header><text>The term <term>authorized representative</term> means, with respect to an individual who is a participant, beneficiary, or enrollee, any health care professional or other person acting on behalf of the individual with the individual’s consent or without such consent if the individual is medically unable to provide such consent.</text></paragraph> <paragraph id="H8FD1D0D2D39F407997369D2BD4333B37"><enum>(2)</enum><header>Claim for benefits</header><text>The term <term>claim for benefits</term> means any request for coverage (including authorization of coverage), for eligibility, or for payment in whole or in part, for an item or service under a group health plan or health insurance coverage.</text></paragraph> <paragraph id="H6AE460161042477E00FF1C791D38355F"><enum>(3)</enum><header>Denial of claim for benefits</header><text>The term <term>denial</term> means, with respect to a claim for benefits, a denial (in whole or in part) of, or a failure to act on a timely basis upon, the claim for benefits and includes a failure to provide benefits (including items and services) required to be provided under this title.</text></paragraph> <paragraph id="H3F367A661B11428E95B28BBE2072C869"><enum>(4)</enum><header>Treating health care professional</header><text>The term <term>treating health care professional</term> means, with respect to services to be provided to a participant, beneficiary, or enrollee, a health care professional who is primarily responsible for delivering those services to the participant, beneficiary, or enrollee.</text></paragraph></subsection></section> <section id="H717328AA939D4717BF00E170A4DBFF87"><enum>103.</enum><header>Internal appeals of claims denials</header> <subsection id="HCD7F84BC25484D538686E883EABC8543"><enum>(a)</enum><header>Right to internal appeal</header> <paragraph id="H4054B2E982194B7499CE4EE9649D6D32"><enum>(1)</enum><header>In general</header><text>A participant, beneficiary, or enrollee (or authorized representative) may appeal any denial of a claim for benefits under section 102 under the procedures described in this section.</text></paragraph> <paragraph id="H866E9B9CB4E04EA1AE3BD8F053EE3240"><enum>(2)</enum><header>Time for appeal</header> <subparagraph id="H701D1F4F17634614AC3376F2DEED00D2"><enum>(A)</enum><header>In general</header><text>A group health plan, and a health insurance issuer offering health insurance coverage, shall ensure that a participant, beneficiary, or enrollee (or authorized representative) has a period of not less than 180 days beginning on the date of a denial of a claim for benefits under section 102 in which to appeal such denial under this section.</text></subparagraph> <subparagraph id="H2CF20F58E5C3419EB3008CDF7C024062"><enum>(B)</enum><header>Date of denial</header><text>For purposes of subparagraph (A), the date of the denial shall be deemed to be the date as of which the participant, beneficiary, or enrollee knew of the denial of the claim for benefits.</text></subparagraph></paragraph> <paragraph id="H415DED98CEE24F36B83F74A647D669F"><enum>(3)</enum><header>Failure to Act</header><text>The failure of a plan or issuer to issue a determination on a claim for benefits under section 102 within the applicable timeline established for such a determination under such section is a denial of a claim for benefits for purposes this subtitle as of the date of the applicable deadline.</text></paragraph> <paragraph id="HA9140A4280F844A400EBF8235333EB73"><enum>(4)</enum><header>Plan waiver of internal review</header><text>A group health plan, or health insurance issuer offering health insurance coverage, may waive the internal review process under this section. In such case the plan or issuer shall provide notice to the participant, beneficiary, or enrollee (or authorized representative) involved, the participant, beneficiary, or enrollee (or authorized representative) involved shall be relieved of any obligation to complete the internal review involved, and may, at the option of such participant, beneficiary, enrollee, or representative proceed directly to seek further appeal through external review under section 104 or otherwise.</text></paragraph></subsection> <subsection id="H7055B6BB183D48D99D1D36464D93F237"><enum>(b)</enum><header>Timelines for making determinations</header> <paragraph id="H830175AF1A30437CA2F55FDBB9C82EFA"><enum>(1)</enum><header>Oral requests</header><text>In the case of an appeal of a denial of a claim for benefits under this section that involves an expedited or concurrent determination, a participant, beneficiary, or enrollee (or authorized representative) may request such appeal orally. A group health plan, or health insurance issuer offering health insurance coverage, may require that the participant, beneficiary, or enrollee (or authorized representative) provide written confirmation of such request in a timely manner on a form provided by the plan or issuer. In the case of such an oral request for an appeal of a denial, the making of the request (and the timing of such request) shall be treated as the making at that time of a request for an appeal without regard to whether and when a written confirmation of such request is made.</text></paragraph> <paragraph id="H882CEA7FC353495B86EA2349BC271D6E"><enum>(2)</enum><header>Access to information</header> <subparagraph id="H36FD0D22A712406692B4065430F16B4E"><enum>(A)</enum><header>Timely provision of necessary information</header><text>With respect to an appeal of a denial of a claim for benefits, the participant, beneficiary, or enrollee (or authorized representative) and the treating health care professional (if any) shall provide the plan or issuer with access to information requested by the plan or issuer that is necessary to make a determination relating to the appeal. Such access shall be provided not later than 5 days after the date on which the request for information is received, or, in a case described in subparagraph (B) or (C) of paragraph (3), by such earlier time as may be necessary to comply with the applicable timeline under such subparagraph.</text></subparagraph> <subparagraph id="HF811400B518F487EABD1E6C86BFE3993"><enum>(B)</enum><header>Limited effect of failure on plan or issuer’s obligations</header><text>Failure of the participant, beneficiary, or enrollee to comply with the requirements of subparagraph (A) shall not remove the obligation of the plan or issuer to make a decision in accordance with the medical exigencies of the case and as soon as possible, based on the available information, and failure to comply with the time limit established by this paragraph shall not remove the obligation of the plan or issuer to comply with the requirements of this section.</text></subparagraph></paragraph> <paragraph id="HE887E0F5D2234D669DB65A489D4E153"><enum>(3)</enum><header>Prior authorization determinations</header> <subparagraph id="HBF910C5213C34DA500AD631732DF3900"><enum>(A)</enum><header>In general</header><text>Except as provided in this paragraph or paragraph (4), a group health plan, and a health insurance issuer offering health insurance coverage, shall make a determination on an appeal of a denial of a claim for benefits under this subsection in accordance with the medical exigencies of the case and as soon as possible, but in no case later than 14 days from the date on which the plan or issuer receives information that is reasonably necessary to enable the plan or issuer to make a determination on the appeal and in no case later than 28 days after the date the request for the appeal is received.</text></subparagraph> <subparagraph id="HC4F019DE515D4E359120BB396FE4B5FD"><enum>(B)</enum><header>Expedited determination</header><text>Notwithstanding subparagraph (A), a group health plan, and a health insurance issuer offering health insurance coverage, shall expedite a prior authorization determination on an appeal of a denial of a claim for benefits described in subparagraph (A), when a request for such an expedited determination is made by a participant, beneficiary, or enrollee (or authorized representative) at any time during the process for making a determination and a health care professional certifies, with the request, that a determination under the procedures described in subparagraph (A) would seriously jeopardize the life or health of the participant, beneficiary, or enrollee or the ability of the participant, beneficiary, or enrollee to maintain or regain maximum function. Such determination shall be made in accordance with the medical exigencies of the case and as soon as possible, but in no case later than 72 hours after the time the request for such appeal is received by the plan or issuer under this subparagraph.</text></subparagraph> <subparagraph id="H9ABA4C754F3D430FAB7D774D68C1585C"><enum>(C)</enum><header>Ongoing care determinations</header> <clause id="H0FDDE01196E14995888521FB0792F02B"><enum>(i)</enum><header>In general</header><text>Subject to clause (ii), in the case of a concurrent review determination described in section 102(b)(1)(C)(i)(I), which results in a termination or reduction of such care, the plan or issuer must provide notice of the determination on the appeal under this section by telephone and in printed form to the individual or the individual’s designee and the individual’s health care provider in accordance with the medical exigencies of the case and as soon as possible, with sufficient time prior to the termination or reduction to allow for an external appeal under section 104 to be completed before the termination or reduction takes effect.</text></clause> <clause id="H821C072AF00D4C7B82F2A8978D66FB2"><enum>(ii)</enum><header>Rule of construction</header><text>Clause (i) shall not be construed as requiring plans or issuers to provide coverage of care that would exceed the coverage limitations for such care.</text></clause></subparagraph></paragraph> <paragraph id="H6B109BF96DEC497D0068BF8C3B1D4ED6"><enum>(4)</enum><header>Retrospective determination</header><text>A group health plan, and a health insurance issuer offering health insurance coverage, shall make a retrospective determination on an appeal of a denial of a claim for benefits in no case later than 30 days after the date on which the plan or issuer receives necessary information that is reasonably necessary to enable the plan or issuer to make a determination on the appeal and in no case later than 60 days after the date the request for the appeal is received.</text></paragraph></subsection> <subsection id="H975B1533237A403F9ED972CB8E5100CE"><enum>(c)</enum><header>Conduct of review</header> <paragraph id="H625899B3865F4EA281F83752BA63BA00"><enum>(1)</enum><header>In general</header><text>A review of a denial of a claim for benefits under this section shall be conducted by an individual with appropriate expertise who was not involved in the initial determination.</text></paragraph> <paragraph id="HB1017CB56AA440B4AF54CA6127DA6771"><enum>(2)</enum><header>Peer review of medical decisions by health care professionals</header><text>A review of an appeal of a denial of a claim for benefits that is based on a lack of medical necessity and appropriateness, or based on an experimental or investigational treatment, or requires an evaluation of medical facts—</text> <subparagraph id="H4A857B72C4224479A4A1927CF23FE41E"><enum>(A)</enum><text>shall be made by a physician (allopathic or osteopathic); or</text></subparagraph> <subparagraph id="H3748C99201164419B99C70B0F1673D73"><enum>(B)</enum><text>in a claim for benefits provided by a non-physician health professional, shall be made by reviewer (or reviewers) including at least one practicing non-physician health professional of the same or similar specialty;</text></subparagraph><continuation-text continuation-text-level="paragraph">with appropriate expertise (including, in the case of a child, appropriate pediatric expertise) and acting within the appropriate scope of practice within the State in which the service is provided or rendered, who was not involved in the initial determination.</continuation-text></paragraph></subsection> <subsection id="HEF7C2F70A21345FDB071A391DAAFA93"><enum>(d)</enum><header>Notice of determination</header> <paragraph id="HE56C3B3C60B7457C9C00930675CE7D81"><enum>(1)</enum><header>In general</header><text>Written notice of a determination made under an internal appeal of a denial of a claim for benefits shall be issued to the participant, beneficiary, or enrollee (or authorized representative) and the treating health care professional in accordance with the medical exigencies of the case and as soon as possible, but in no case later than 2 days after the date of completion of the review (or, in the case described in subparagraph (B) or (C) of subsection (b)(3), within the 72-hour or applicable period referred to in such subparagraph).</text></paragraph> <paragraph id="H13DA496DE56E42CBA100B099EE76D12B"><enum>(2)</enum><header>Final determination</header><text>The decision by a plan or issuer under this section shall be treated as the final determination of the plan or issuer on a denial of a claim for benefits. The failure of a plan or issuer to issue a determination on an appeal of a denial of a claim for benefits under this section within the applicable timeline established for such a determination shall be treated as a final determination on an appeal of a denial of a claim for benefits for purposes of proceeding to external review under section 104.</text></paragraph> <paragraph id="HC6B6C42D8CE14D7D8D23175B51FDD93D"><enum>(3)</enum><header>Requirements of notice</header><text>With respect to a determination made under this section, the notice described in paragraph (1) shall be provided in printed form and written in a manner calculated to be understood by the participant, beneficiary, or enrollee and shall include—</text> <subparagraph id="H2C36F502AC1E4DDBAD38FCA634A93913"><enum>(A)</enum><text>the specific reasons for the determination (including a summary of the clinical or scientific evidence used in making the determination);</text></subparagraph> <subparagraph id="H1BA0437F5F9748838CA3189759E692C"><enum>(B)</enum><text>the procedures for obtaining additional information concerning the determination; and</text></subparagraph> <subparagraph id="H7CEEBB10ED7D422FAA325FF77F4D3093"><enum>(C)</enum><text>notification of the right to an independent external review under section 104 and instructions on how to initiate such a review.</text></subparagraph></paragraph></subsection></section> <section id="H01508C9F7F9B438793C45B3472BC04F7"><enum>104.</enum><header>Independent external appeals procedures</header> <subsection id="H653B3735AC9A4755BBB4C74C1764C6D8"><enum>(a)</enum><header>Right to external appeal</header><text>A group health plan, and a health insurance issuer offering health insurance coverage, shall provide in accordance with this section participants, beneficiaries, and enrollees (or authorized representatives) with access to an independent external review for any denial of a claim for benefits.</text></subsection> <subsection id="H15B72A64C2934B66BD3F18F770465EA4"><enum>(b)</enum><header>Initiation of the independent external review process</header> <paragraph id="H79E222C9DD80485EB491D8AF5F99009F"><enum>(1)</enum><header>Time to file</header><text>A request for an independent external review under this section shall be filed with the plan or issuer not later than 180 days after the date on which the participant, beneficiary, or enrollee receives notice of the denial under section 103(d) or notice of waiver of internal review under section 103(a)(4) or the date on which the plan or issuer has failed to make a timely decision under section 103(d)(2) and notifies the participant or beneficiary that it has failed to make a timely decision and that the beneficiary must file an appeal with an external review entity within 180 days if the participant or beneficiary desires to file such an appeal.</text></paragraph> <paragraph id="H68F457C1FC9542670013DFB87CECB250"><enum>(2)</enum><header>Filing of request</header> <subparagraph id="HDAF3DDA2086F4A9C84FDD1758F244BD"><enum>(A)</enum><header>In general</header><text>Subject to the succeeding provisions of this subsection, a group health plan, or health insurance issuer offering health insurance coverage, may—</text> <clause id="H733759147B46420E9DFB42D45DDAC902"><enum>(i)</enum><text>except as provided in subparagraph (B)(i), require that a request for review be in writing;</text></clause> <clause id="H54F7B17B83944A22B5F3E960DC951046"><enum>(ii)</enum><text>limit the filing of such a request to the participant, beneficiary, or enrollee involved (or an authorized representative);</text></clause> <clause id="H841B086EC3864586B534F4AEB6472B10"><enum>(iii)</enum><text>except if waived by the plan or issuer under section 103(a)(4), condition access to an independent external review under this section upon a final determination of a denial of a claim for benefits under the internal review procedure under section 103;</text></clause> <clause id="H9D0A4DF138654711BC7B00CEDADCE00"><enum>(iv)</enum><text>except as provided in subparagraph (B)(ii), require payment of a filing fee to the plan or issuer of a sum that does not exceed $25; and</text></clause> <clause id="HF214EE805C5F44CA9D00D3AC104B77F8"><enum>(v)</enum><text>require that a request for review include the consent of the participant, beneficiary, or enrollee (or authorized representative) for the release of necessary medical information or records of the participant, beneficiary, or enrollee to the qualified external review entity only for purposes of conducting external review activities.</text></clause></subparagraph> <subparagraph id="HC29C52DD814A4B47ABF7D91C97D750D"><enum>(B)</enum><header>Requirements and exception relating to general rule</header> <clause id="H3F25806D80C84189A97500009B2EA288"><enum>(i)</enum><header>Oral requests permitted in expedited or concurrent cases</header><text>In the case of an expedited or concurrent external review as provided for under subsection (e), the request for such review may be made orally. A group health plan, or health insurance issuer offering health insurance coverage, may require that the participant, beneficiary, or enrollee (or authorized representative) provide written confirmation of such request in a timely manner on a form provided by the plan or issuer. Such written confirmation shall be treated as a consent for purposes of subparagraph (A)(v). In the case of such an oral request for such a review, the making of the request (and the timing of such request) shall be treated as the making at that time of a request for such a review without regard to whether and when a written confirmation of such request is made.</text></clause> <clause id="H090006C425984E4F998C4D86D06353D5"><enum>(ii)</enum><header>Exception to filing fee requirement</header> <subclause id="H2525E57DDE124EB89574E253CD513FDD"><enum>(I)</enum><header>Indigency</header><text>Payment of a filing fee shall not be required under subparagraph (A)(iv) where there is a certification (in a form and manner specified in guidelines established by the appropriate Secretary) that the participant, beneficiary, or enrollee is indigent (as defined in such guidelines).</text></subclause> <subclause id="HC4546E5F1F5F466680DCAADDE9D100EE"><enum>(II)</enum><header>Fee not required</header><text>Payment of a filing fee shall not be required under subparagraph (A)(iv) if the plan or issuer waives the internal appeals process under section 103(a)(4).</text></subclause> <subclause id="HACE3CAC3FE9B4850ABBDD582DE72B2CC"><enum>(III)</enum><header>Refunding of fee</header><text>The filing fee paid under subparagraph (A)(iv) shall be refunded if the determination under the independent external review is to reverse or modify the denial which is the subject of the review.</text></subclause> <subclause id="HA1B356B38AFF425D833288C84C5FCA34"><enum>(IV)</enum><header>Collection of filing fee</header><text>The failure to pay such a filing fee shall not prevent the consideration of a request for review but, subject to the preceding provisions of this clause, shall constitute a legal liability to pay.</text></subclause></clause></subparagraph></paragraph></subsection> <subsection id="H418D1B4D50B04ADAB2A407D5E300FB79"><enum>(c)</enum><header>Referral to qualified external review entity upon request</header> <paragraph id="H49F05D91A674433FAF91CB47524CB7AC"><enum>(1)</enum><header>In general</header><text>Upon the filing of a request for independent external review with the group health plan, or health insurance issuer offering health insurance coverage, the plan or issuer shall immediately refer such request, and forward the plan or issuer’s initial decision (including the information described in section 103(d)(3)(A)), to a qualified external review entity selected in accordance with this section.</text></paragraph> <paragraph id="H6B702095852A4C8085EF6C941E18D86B"><enum>(2)</enum><header>Access to plan or issuer and health professional information</header><text>With respect to an independent external review conducted under this section, the participant, beneficiary, or enrollee (or authorized representative), the plan or issuer, and the treating health care professional (if any) shall provide the external review entity with information that is necessary to conduct a review under this section, as determined and requested by the entity. Such information shall be provided not later than 5 days after the date on which the request for information is received, or, in a case described in clause (ii) or (iii) of subsection (e)(1)(A), by such earlier time as may be necessary to comply with the applicable timeline under such clause.</text></paragraph> <paragraph id="HE7548A212240469DB6943F4727974C87"><enum>(3)</enum><header>Screening of requests by qualified external review entities</header> <subparagraph id="H1AC60F1609F54023BAB042D21BA7514E"><enum>(A)</enum><header>In general</header><text>With respect to a request referred to a qualified external review entity under paragraph (1) relating to a denial of a claim for benefits, the entity shall refer such request for the conduct of an independent medical review unless the entity determines that—</text> <clause id="HAE4B9F8043F74535A69993FED2A73742"><enum>(i)</enum><text>any of the conditions described in clauses (ii) or (iii) of subsection (b)(2)(A) have not been met;</text></clause> <clause id="H442411363E774F1BA98DE01201F280DE"><enum>(ii)</enum><text>the denial of the claim for benefits does not involve a medically reviewable decision under subsection (d)(2);</text></clause> <clause id="H0119B477ED3B4336B898A17B6017374"><enum>(iii)</enum><text>the denial of the claim for benefits relates to a decision regarding whether an individual is a participant, beneficiary, or enrollee who is enrolled under the terms and conditions of the plan or coverage (including the applicability of any waiting period under the plan or coverage); or</text></clause> <clause id="H16BCF99666D94707A30672006E753928"><enum>(iv)</enum><text>the denial of the claim for benefits is a decision as to the application of cost-sharing requirements or the application of a specific exclusion or express limitation on the amount, duration, or scope of coverage of items or services under the terms and conditions of the plan or coverage unless the decision is a denial described in subsection (d)(2).</text></clause><continuation-text continuation-text-level="subparagraph">Upon making a determination that any of clauses (i) through (iv) applies with respect to the request, the entity shall determine that the denial of a claim for benefits involved is not eligible for independent medical review under subsection (d), and shall provide notice in accordance with subparagraph (C).</continuation-text></subparagraph> <subparagraph id="HDC708261410E4A019D832B609040EBA7"><enum>(B)</enum><header>Process for making determinations</header> <clause id="H7175683C73834416838B27BFE54230DE"><enum>(i)</enum><header>No deference to prior determinations</header><text>In making determinations under subparagraph (A), there shall be no deference given to determinations made by the plan or issuer or the recommendation of a treating health care professional (if any).</text></clause> <clause id="HE8D5B8B64BEE46FC819D51A66D70EBF"><enum>(ii)</enum><header>Use of appropriate personnel</header><text>A qualified external review entity shall use appropriately qualified personnel to make determinations under this section.</text></clause></subparagraph> <subparagraph id="HBC6C9860195F427FBFA0AEE8C1E7197"><enum>(C)</enum><header>Notices and general timelines for determination</header> <clause id="H7EBF21F3457342A999CBB4406BB0094"><enum>(i)</enum><header>Notice in case of denial of referral</header><text>If the entity under this paragraph does not make a referral to an independent medical reviewer, the entity shall provide notice to the plan or issuer, the participant, beneficiary, or enrollee (or authorized representative) filing the request, and the treating health care professional (if any) that the denial is not subject to independent medical review. Such notice—</text> <subclause id="H1F7A06C76C4B4E898BAA0030E5DC4300"><enum>(I)</enum><text>shall be written (and, in addition, may be provided orally) in a manner calculated to be understood by a participant or enrollee;</text></subclause> <subclause id="HA66AE5E06C7D4C8697C6946C82FED017"><enum>(II)</enum><text>shall include the reasons for the determination;</text></subclause> <subclause id="HF1F8838494AD4598A9A5FFF2B737FC39"><enum>(III)</enum><text>include any relevant terms and conditions of the plan or coverage; and</text></subclause> <subclause id="H948FDC7BF5B34BA189341F22769BDF7"><enum>(IV)</enum><text>include a description of any further recourse available to the individual.</text></subclause></clause> <clause id="H8B87E392ECF2499B8876019000003FFF"><enum>(ii)</enum><header>General timeline for determinations</header><text>Upon receipt of information under paragraph (2), the qualified external review entity, and if required the independent medical reviewer, shall make a determination within the overall timeline that is applicable to the case under review as described in subsection (e), except that if the entity determines that a referral to an independent medical reviewer is not required, the entity shall provide notice of such determination to the participant, beneficiary, or enrollee (or authorized representative) within such timeline and within 2 days of the date of such determination.</text></clause></subparagraph></paragraph></subsection> <subsection id="HCD42BAEA14FB4DC181C35BDDC6E876C8"><enum>(d)</enum><header>Independent medical review</header> <paragraph id="H29A2BA3044F64FBCAE9501CBB70830EF"><enum>(1)</enum><header>In general</header><text>If a qualified external review entity determines under subsection (c) that a denial of a claim for benefits is eligible for independent medical review, the entity shall refer the denial involved to an independent medical reviewer for the conduct of an independent medical review under this subsection.</text></paragraph> <paragraph id="H0F4858C26BFE42558597AEAAEA028F3"><enum>(2)</enum><header>Medically reviewable decisions</header><text>A denial of a claim for benefits is eligible for independent medical review if the benefit for the item or service for which the claim is made would be a covered benefit under the terms and conditions of the plan or coverage but for one (or more) of the following determinations:</text> <subparagraph id="H64A34744AD2744449CCF7FB563D71CF1"><enum>(A)</enum><header>Denials based on medical necessity and appropriateness</header><text>A determination that the item or service is not covered because it is not medically necessary and appropriate or based on the application of substantially equivalent terms.</text></subparagraph> <subparagraph id="H1C6689E33E7F4F4F87FDE4060063E21"><enum>(B)</enum><header>Denials based on experimental or investigational treatment</header><text>A determination that the item or service is not covered because it is experimental or investigational or based on the application of substantially equivalent terms.</text></subparagraph> <subparagraph id="H46A9F36D054E4F77AC01783020259FA2"><enum>(C)</enum><header>Denials otherwise based on an evaluation of medical facts</header><text>A determination that the item or service or condition is not covered based on grounds that require an evaluation of the medical facts by a health care professional in the specific case involved to determine the coverage and extent of coverage of the item or service or condition.</text></subparagraph></paragraph> <paragraph id="H5774D4C4DF2A40E4860242835964CA2E"><enum>(3)</enum><header>Independent medical review determination</header> <subparagraph id="H5560F65DDB0D427390BFB475F3758DF1"><enum>(A)</enum><header>In general</header><text>An independent medical reviewer under this section shall make a new independent determination with respect to whether or not the denial of a claim for a benefit that is the subject of the review should be upheld, reversed, or modified.</text></subparagraph> <subparagraph id="HFE7CFD3185BF409DBC29E6D3000000D6"><enum>(B)</enum><header>Standard for determination</header><text>The independent medical reviewer’s determination relating to the medical necessity and appropriateness, or the experimental or investigational nature, or the evaluation of the medical facts, of the item, service, or condition involved shall be based on the medical condition of the participant, beneficiary, or enrollee (including the medical records of the participant, beneficiary, or enrollee) and valid, relevant scientific evidence and clinical evidence, including peer-reviewed medical literature or findings and including expert opinion.</text></subparagraph> <subparagraph id="HEF3C5AB983DC47F4A4161E97698BEACF"><enum>(C)</enum><header>No coverage for excluded benefits</header><text>Nothing in this subsection shall be construed to permit an independent medical reviewer to require that a group health plan, or health insurance issuer offering health insurance coverage, provide coverage for items or services for which benefits are specifically excluded or expressly limited under the plan or coverage in the plain language of the plan document (and which are disclosed under section 121(b)(1)(C)). Notwithstanding any other provision of this Act, any exclusion of an exact medical procedure, any exact time limit on the duration or frequency of coverage, and any exact dollar limit on the amount of coverage that is specifically enumerated and defined (in the plain language of the plan or coverage documents) under the plan or coverage offered by a group health plan or health insurance issuer offering health insurance coverage and that is disclosed under section 121(b)(1) shall be considered to govern the scope of the benefits that may be required: <italic>Provided, </italic>That the terms and conditions of the plan or coverage relating to such an exclusion or limit are in compliance with the requirements of law.</text></subparagraph> <subparagraph id="H6C22C7BB26E94AE5B58348CBE900FF8C"><enum>(D)</enum><header>Evidence and information to be used in medical reviews</header><text>In making a determination under this subsection, the independent medical reviewer shall also consider appropriate and available evidence and information, including the following:</text> <clause id="HA2EB96933BF440FA8829AEB68637DAFF"><enum>(i)</enum><text>The determination made by the plan or issuer with respect to the claim upon internal review and the evidence, guidelines, or rationale used by the plan or issuer in reaching such determination.</text></clause> <clause id="H19657BCDE28E486AB49B63ABABE4D87"><enum>(ii)</enum><text>The recommendation of the treating health care professional and the evidence, guidelines, and rationale used by the treating health care professional in reaching such recommendation.</text></clause> <clause id="HAC0B5540F9394856AFFFED7E0684AC41"><enum>(iii)</enum><text>Additional relevant evidence or information obtained by the reviewer or submitted by the plan, issuer, participant, beneficiary, or enrollee (or an authorized representative), or treating health care professional.</text></clause> <clause id="H11FE5260FB094A58815EC301B3252C1F"><enum>(iv)</enum><text>The plan or coverage document.</text></clause></subparagraph> <subparagraph id="H76473FD930034CD1B95B93319F48BC8D"><enum>(E)</enum><header>Independent determination</header><text>In making determinations under this section, a qualified external review entity and an independent medical reviewer shall—</text> <clause id="H1691993543FA48AA863304A61F7FB79"><enum>(i)</enum><text>consider the claim under review without deference to the determinations made by the plan or issuer or the recommendation of the treating health care professional (if any); and</text></clause> <clause id="H692C5F61F6A84421BF2FA2313DE8F31"><enum>(ii)</enum><text>consider, but not be bound by, the definition used by the plan or issuer of <quote>medically necessary and appropriate</quote>, or <quote>experimental or investigational</quote>, or other substantially equivalent terms that are used by the plan or issuer to describe medical necessity and appropriateness or experimental or investigational nature of the treatment.</text></clause></subparagraph> <subparagraph id="H2FA3D2A68A0E4926A8E9731F42808086"><enum>(F)</enum><header>Determination of independent medical reviewer</header><text>An independent medical reviewer shall, in accordance with the deadlines described in subsection (e), prepare a written determination to uphold, reverse, or modify the denial under review. Such written determination shall include—</text> <clause id="H5A9FF89891D645E5B642A12AACC1EE5"><enum>(i)</enum><text>the determination of the reviewer;</text></clause> <clause id="HDA3E0D32BEAD47F69E464E8CF7EDE4B2"><enum>(ii)</enum><text>the specific reasons of the reviewer for such determination, including a summary of the clinical or scientific evidence used in making the determination; and</text></clause> <clause id="H093EE924D2E24026AF7E167F16396B32"><enum>(iii)</enum><text>with respect to a determination to reverse or modify the denial under review, a timeframe within which the plan or issuer must comply with such determination.</text></clause></subparagraph> <subparagraph id="HC7B13DC6B4EA40A883E900496C34ECC8"><enum>(G)</enum><header>Nonbinding nature of additional recommendations</header><text>In addition to the determination under subparagraph (F), the reviewer may provide the plan or issuer and the treating health care professional with additional recommendations in connection with such a determination, but any such recommendations shall not affect (or be treated as part of) the determination and shall not be binding on the plan or issuer.</text></subparagraph></paragraph></subsection> <subsection id="H677079287FD14793BCD81D86A99CFB1C"><enum>(e)</enum><header>Timelines and notifications</header> <paragraph id="HC4F9A60AE5D24494A8227B005F9FC3CE"><enum>(1)</enum><header>Timelines for independent medical review</header> <subparagraph id="HE989AE58449A46C9946BB1B232EFF64D"><enum>(A)</enum><header>Prior authorization determination</header> <clause id="H2BF52A80B0594F19B5F13E4411D3B400"><enum>(i)</enum><header>In general</header><text>The independent medical reviewer (or reviewers) shall make a determination on a denial of a claim for benefits that is referred to the reviewer under subsection (c)(3) in accordance with the medical exigencies of the case and as soon as possible, but in no case later than 14 days after the date of receipt of information under subsection (c)(2) if the review involves a prior authorization of items or services and in no case later than 21 days after the date the request for external review is received.</text></clause> <clause id="H26D782154D464B58A6C725082EE56C2E"><enum>(ii)</enum><header>Expedited determination</header><text>Notwithstanding clause (i) and subject to clause (iii), the independent medical reviewer (or reviewers) shall make an expedited determination on a denial of a claim for benefits described in clause (i), when a request for such an expedited determination is made by a participant, beneficiary, or enrollee (or authorized representative) at any time during the process for making a determination, and a health care professional certifies, with the request, that a determination under the timeline described in clause (i) would seriously jeopardize the life or health of the participant, beneficiary, or enrollee or the ability of the participant, beneficiary, or enrollee to maintain or regain maximum function. Such determination shall be made in accordance with the medical exigencies of the case and as soon as possible, but in no case later than 72 hours after the time the request for external review is received by the qualified external review entity.</text></clause> <clause id="H9A1E4EEE7D974C9486BE89C02FD9C9C0"><enum>(iii)</enum><header>Ongoing care determination</header><text>Notwithstanding clause (i), in the case of a review described in such clause that involves a termination or reduction of care, the notice of the determination shall be completed not later than 24 hours after the time the request for external review is received by the qualified external review entity and before the end of the approved period of care.</text></clause></subparagraph> <subparagraph id="H09AA86887F1E45A2AF253671A9B6E16"><enum>(B)</enum><header>Retrospective determination</header><text>The independent medical reviewer (or reviewers) shall complete a review in the case of a retrospective determination on an appeal of a denial of a claim for benefits that is referred to the reviewer under subsection (c)(3) in no case later than 30 days after the date of receipt of information under subsection (c)(2) and in no case later than 60 days after the date the request for external review is received by the qualified external review entity.</text></subparagraph></paragraph> <paragraph id="H4E19E234D67040E4BA56E559CA32DE51"><enum>(2)</enum><header>Notification of determination</header><text>The external review entity shall ensure that the plan or issuer, the participant, beneficiary, or enrollee (or authorized representative) and the treating health care professional (if any) receives a copy of the written determination of the independent medical reviewer prepared under subsection (d)(3)(F). Nothing in this paragraph shall be construed as preventing an entity or reviewer from providing an initial oral notice of the reviewer’s determination.</text></paragraph> <paragraph id="H521B5961FC0B43348C1208721BA88792"><enum>(3)</enum><header>Form of notices</header><text>Determinations and notices under this subsection shall be written in a manner calculated to be understood by a participant.</text></paragraph></subsection> <subsection id="H9807F56259A34C5B96BCADAFAA1289C1"><enum>(f)</enum><header>Compliance</header> <paragraph id="H6D891B5284C24719A29DA2A188CE17AD"><enum>(1)</enum><header>Application of determinations</header> <subparagraph id="H7A7C2401A64C4FABB06800B808F0FD08"><enum>(A)</enum><header>External review determinations binding on plan</header><text>The determinations of an external review entity and an independent medical reviewer under this section shall be binding upon the plan or issuer involved.</text></subparagraph> <subparagraph id="H3A28BD42E66340738B592D53F0730003"><enum>(B)</enum><header>Compliance with determination</header><text>If the determination of an independent medical reviewer is to reverse or modify the denial, the plan or issuer, upon the receipt of such determination, shall authorize coverage to comply with the medical reviewer’s determination in accordance with the timeframe established by the medical reviewer.</text></subparagraph></paragraph> <paragraph id="H27EC6FB0DF3F497C998FF0A4BBC7F54F"><enum>(2)</enum><header>Failure to comply</header> <subparagraph id="H5D51C3F9E1C144C9A98843A5345978A2"><enum>(A)</enum><header>In general</header><text>If a plan or issuer fails to comply with the timeframe established under paragraph (1)(B) with respect to a participant, beneficiary, or enrollee, where such failure to comply is caused by the plan or issuer, the participant, beneficiary, or enrollee may obtain the items or services involved (in a manner consistent with the determination of the independent external reviewer) from any provider regardless of whether such provider is a participating provider under the plan or coverage.</text></subparagraph> <subparagraph id="H9C37D057002844ABA01FE5E44FF0CAC9"><enum>(B)</enum><header>Reimbursement</header> <clause id="H10B5C6EDCCB14051A1B4F2356E9BD0B5"><enum>(i)</enum><header>In general</header><text>Where a participant, beneficiary, or enrollee obtains items or services in accordance with subparagraph (A), the plan or issuer involved shall provide for reimbursement of the costs of such items or services. Such reimbursement shall be made to the treating health care professional or to the participant, beneficiary, or enrollee (in the case of a participant, beneficiary, or enrollee who pays for the costs of such items or services).</text></clause> <clause id="H79A85C850D214A36B384D900AEAB1BA2"><enum>(ii)</enum><header>Amount</header><text>The plan or issuer shall fully reimburse a professional, participant, beneficiary, or enrollee under clause (i) for the total costs of the items or services provided (regardless of any plan limitations that may apply to the coverage of such items or services) so long as the items or services were provided in a manner consistent with the determination of the independent medical reviewer.</text></clause></subparagraph> <subparagraph id="HE96B9F3C071C4C72BD15A9886BC3027"><enum>(C)</enum><header>Failure to reimburse</header><text>Where a plan or issuer fails to provide reimbursement to a professional, participant, beneficiary, or enrollee in accordance with this paragraph, the professional, participant, beneficiary, or enrollee may commence a civil action (or utilize other remedies available under law) to recover only the amount of any such reimbursement that is owed by the plan or issuer and any necessary legal costs or expenses (including attorney’s fees) incurred in recovering such reimbursement.</text></subparagraph> <subparagraph id="H3549D7CDC78E4BE8B318C6DBCF9D15"><enum>(D)</enum><header>Available remedies</header><text>The remedies provided under this paragraph are in addition to any other available remedies.</text></subparagraph></paragraph> <paragraph id="HD984C78A048B45DEAB1B30D5179E1E5D"><enum>(3)</enum><header>Penalties against authorized officials for refusing to authorize the determination of an external review entity</header> <subparagraph id="H3C66648F181F4BE6BA70966BBABF9C57"><enum>(A)</enum><header>Monetary penalties</header> <clause id="H2C6E1698F4A64A87B019C102B3854781"><enum>(i)</enum><header>In general</header><text>In any case in which the determination of an external review entity is not followed by a group health plan, or by a health insurance issuer offering health insurance coverage, any person who, acting in the capacity of authorizing the benefit, causes such refusal may, in the discretion of a court of competent jurisdiction, be liable to an aggrieved participant, beneficiary, or enrollee for a civil penalty in an amount of up to $1,000 a day from the date on which the determination was transmitted to the plan or issuer by the external review entity until the date the refusal to provide the benefit is corrected.</text></clause> <clause id="HE5A42F7908964B74ADFB973FA57D111C"><enum>(ii)</enum><header>Additional penalty for failing to follow timeline</header><text>In any case in which treatment was not commenced by the plan in accordance with the determination of an independent external reviewer, the Secretary shall assess a civil penalty of $10,000 against the plan and the plan shall pay such penalty to the participant, beneficiary, or enrollee involved.</text></clause></subparagraph> <subparagraph id="H299D60C850AC46A483D4465E2EB5A41C"><enum>(B)</enum><header>Cease and desist order and order of attorney’s fees</header><text>In any action described in subparagraph (A) brought by a participant, beneficiary, or enrollee with respect to a group health plan, or a health insurance issuer offering health insurance coverage, in which a plaintiff alleges that a person referred to in such subparagraph has taken an action resulting in a refusal of a benefit determined by an external appeal entity to be covered, or has failed to take an action for which such person is responsible under the terms and conditions of the plan or coverage and which is necessary under the plan or coverage for authorizing a benefit, the court shall cause to be served on the defendant an order requiring the defendant—</text> <clause id="HF83444AE862647FD97CA513E03E0DCF2"><enum>(i)</enum><text>to cease and desist from the alleged action or failure to act; and</text></clause> <clause id="HDF6CB4DC81B0490BA46B41B1D85BDE27"><enum>(ii)</enum><text>to pay to the plaintiff a reasonable attorney’s fee and other reasonable costs relating to the prosecution of the action on the charges on which the plaintiff prevails.</text></clause></subparagraph> <subparagraph id="HE35D9CA1B1904FCB917201AFA9D2798F"><enum>(C)</enum><header>Additional civil penalties</header> <clause id="HE34771D974DA40A4A9DC37612738FF"><enum>(i)</enum><header>In general</header><text>In addition to any penalty imposed under subparagraph (A) or (B), the appropriate Secretary may assess a civil penalty against a person acting in the capacity of authorizing a benefit determined by an external review entity for one or more group health plans, or health insurance issuers offering health insurance coverage, for—</text> <subclause id="H4885A8C7ACEC453B00CDB8026344AEE0"><enum>(I)</enum><text>any pattern or practice of repeated refusal to authorize a benefit determined by an external appeal entity to be covered; or</text></subclause> <subclause id="H5D53D37F3B764F21A56B000040B78027"><enum>(II)</enum><text>any pattern or practice of repeated violations of the requirements of this section with respect to such plan or coverage.</text></subclause></clause> <clause id="H1D2CC8C0070B4537B455DC4020622512"><enum>(ii)</enum><header>Standard of proof and amount of penalty</header><text>Such penalty shall be payable only upon proof by clear and convincing evidence of such pattern or practice and shall be in an amount not to exceed the lesser of—</text> <subclause id="H3E23EDB21C8B47AB82BA92F08B003615"><enum>(I)</enum><text>25 percent of the aggregate value of benefits shown by the appropriate Secretary to have not been provided, or unlawfully delayed, in violation of this section under such pattern or practice; or</text></subclause> <subclause id="HBA143BA415DA4FC6A43DE7FF6C776D7"><enum>(II)</enum><text>$500,000.</text></subclause></clause></subparagraph> <subparagraph id="HE475021988164DBD988C6001B226CE13"><enum>(D)</enum><header>Removal and disqualification</header><text>Any person acting in the capacity of authorizing benefits who has engaged in any such pattern or practice described in subparagraph (C)(i) with respect to a plan or coverage, upon the petition of the appropriate Secretary, may be removed by the court from such position, and from any other involvement, with respect to such a plan or coverage, and may be precluded from returning to any such position or involvement for a period determined by the court.</text></subparagraph></paragraph> <paragraph id="HA69BADFE433148EF958079B2DFC044B"><enum>(4)</enum><header>Protection of legal rights</header><text>Nothing in this subsection or subtitle shall be construed as altering or eliminating any cause of action or legal rights or remedies of participants, beneficiaries, enrollees, and others under State or Federal law (including sections 502 and 503 of the <act-name parsable-cite="ERISA">Employee Retirement Income Security Act of 1974</act-name>), including the right to file judicial actions to enforce rights.</text></paragraph></subsection> <subsection id="HCD4BC216B5C6462C87C5341D0000C48D"><enum>(g)</enum><header>Qualifications of independent medical reviewers</header> <paragraph id="HB785F70E84F84470AF5CCF4CFF07EEC6"><enum>(1)</enum><header>In general</header><text>In referring a denial to 1 or more individuals to conduct independent medical review under subsection (c), the qualified external review entity shall ensure that—</text> <subparagraph id="H418A511680614139AE131F2E54A12071"><enum>(A)</enum><text>each independent medical reviewer meets the qualifications described in paragraphs (2) and (3);</text></subparagraph> <subparagraph id="H2C046CBABD2147A19C53006EEC002D44"><enum>(B)</enum><text>with respect to each review at least 1 such reviewer meets the requirements described in paragraphs (4) and (5); and</text></subparagraph> <subparagraph id="H7CAE1C80E4604FE6B248BEAF48B883D7"><enum>(C)</enum><text>compensation provided by the entity to the reviewer is consistent with paragraph (6).</text></subparagraph></paragraph> <paragraph id="HD57C0B386B8F4F2B87D0F37C69207553"><enum>(2)</enum><header>Licensure and expertise</header><text>Each independent medical reviewer shall be a physician (allopathic or osteopathic) or health care professional who—</text> <subparagraph id="HD8DA3E55F8FE46B3AA4E52929B908100"><enum>(A)</enum><text>is appropriately credentialed or licensed in 1 or more States to deliver health care services; and</text></subparagraph> <subparagraph id="H1672D820BED542E8804B666C747E8294"><enum>(B)</enum><text>typically treats the condition, makes the diagnosis, or provides the type of treatment under review.</text></subparagraph></paragraph> <paragraph id="H2C1C334E0FFE44C4B15200E932D2892"><enum>(3)</enum><header>Independence</header> <subparagraph id="H57D4060217EC4874B9AF2546E1A595B"><enum>(A)</enum><header>In general</header><text>Subject to subparagraph (B), each independent medical reviewer in a case shall—</text> <clause id="H7CF715AD16794F7DA483002FFF53E7AD"><enum>(i)</enum><text>not be a related party (as defined in paragraph (7));</text></clause> <clause id="HB98E3903DF8B4D47BE2055A19600B505"><enum>(ii)</enum><text>not have a material familial, financial, or professional relationship with such a party; and</text></clause> <clause id="H9917C165417A41A99BD62E4459E91D4B"><enum>(iii)</enum><text>not otherwise have a conflict of interest with such a party (as determined under regulations).</text></clause></subparagraph> <subparagraph id="HAF0E1D97125F496F8EC990A9AC18E3C1"><enum>(B)</enum><header>Exception</header><text>Nothing in subparagraph (A) shall be construed to—</text> <clause id="H869252653DBC4CCC935116B95C6B00BC"><enum>(i)</enum><text>prohibit an individual, solely on the basis of affiliation with the plan or issuer, from serving as an independent medical reviewer if—</text> <subclause id="H64C672B580534AFEB3FFC2D3E42880A3"><enum>(I)</enum><text>a non-affiliated individual is not reasonably available;</text></subclause> <subclause id="H3D7BA91A5E5E437D873727A5F35BC128"><enum>(II)</enum><text>the affiliated individual is not involved in the provision of items or services in the case under review;</text></subclause> <subclause id="H4BE6713ACD754905910000AFF115BFFB"><enum>(III)</enum><text>the fact of such an affiliation is disclosed to the plan or issuer and the participant, beneficiary, or enrollee (or authorized representative) and neither party objects; and</text></subclause> <subclause id="HB6E5D257E4D3402995B5566E614009B8"><enum>(IV)</enum><text>the affiliated individual is not an employee of the plan or issuer and does not provide services exclusively or primarily to or on behalf of the plan or issuer;</text></subclause></clause> <clause id="HC0F16AD5DCFD408BBEE85D6B55364674"><enum>(ii)</enum><text>prohibit an individual who has staff privileges at the institution where the treatment involved takes place from serving as an independent medical reviewer merely on the basis of such affiliation if the affiliation is disclosed to the plan or issuer and the participant, beneficiary, or enrollee (or authorized representative), and neither party objects; or</text></clause> <clause id="HCB3C508CEFC845ACA105F83965449E"><enum>(iii)</enum><text>prohibit receipt of compensation by an independent medical reviewer from an entity if the compensation is provided consistent with paragraph (6).</text></clause></subparagraph></paragraph> <paragraph id="H3FF79DDE59DC408E84C76279F33900DF"><enum>(4)</enum><header>Practicing health care professional in same field</header> <subparagraph id="H25AA56AFF352416F8BBCF2EC758EAD5F"><enum>(A)</enum><header>In general</header><text>In a case involving treatment, or the provision of items or services—</text> <clause id="H65B69EC8EA3D4EA8B950B36D444D2B6F"><enum>(i)</enum><text>by a physician, a reviewer shall be a practicing physician (allopathic or osteopathic) of the same or similar specialty, as a physician who, acting within the appropriate scope of practice within the State in which the service is provided or rendered, typically treats the condition, makes the diagnosis, or provides the type of treatment under review; or</text></clause> <clause id="H78DACA291221438397B4E30B0953079"><enum>(ii)</enum><text>by a non-physician health care professional, a reviewer (or reviewers) shall include at least one practicing non-physician health care professional of the same or similar specialty as the non-physician health care professional who, acting within the appropriate scope of practice within the State in which the service is provided or rendered, typically treats the condition, makes the diagnosis, or provides the type of treatment under review.</text></clause></subparagraph> <subparagraph id="H3BBA03565674413F9FF9EA41EEF6A51E"><enum>(B)</enum><header>Practicing defined</header><text>For purposes of this paragraph, the term <term>practicing</term> means, with respect to an individual who is a physician or other health care professional that the individual provides health care services to individual patients on average at least 2 days per week.</text></subparagraph></paragraph> <paragraph id="HD0893573AFCF43DAAAE98006B61DEB81"><enum>(5)</enum><header>Pediatric expertise</header><text>In the case of an external review relating to a child, a reviewer shall have expertise under paragraph (2) in pediatrics.</text></paragraph> <paragraph id="H698FBC46CD66438AA3F20001BE7C0024"><enum>(6)</enum><header>Limitations on reviewer compensation</header><text>Compensation provided by a qualified external review entity to an independent medical reviewer in connection with a review under this section shall—</text> <subparagraph id="H7A497C91275C49229F3BE4EAB476C126"><enum>(A)</enum><text>not exceed a reasonable level; and</text></subparagraph> <subparagraph id="H5843E6DFCEF84A2CA159E72976CD934F"><enum>(B)</enum><text>not be contingent on the decision rendered by the reviewer.</text></subparagraph></paragraph> <paragraph id="H3BF696202BF2457389034FAA97EAAF42"><enum>(7)</enum><header>Related party defined</header><text>For purposes of this section, the term <term>related party</term> means, with respect to a denial of a claim under a plan or coverage relating to a participant, beneficiary, or enrollee, any of the following:</text> <subparagraph id="H5B1B6811F1F64293AE2FB78BE7DD4C32"><enum>(A)</enum><text>The plan, plan sponsor, or issuer involved, or any fiduciary, officer, director, or employee of such plan, plan sponsor, or issuer.</text></subparagraph> <subparagraph id="H492E7E372AD34FA9BAE1001520A18D23"><enum>(B)</enum><text>The participant, beneficiary, or enrollee (or authorized representative).</text></subparagraph> <subparagraph id="H7E919D69AC07486993CB005C029BF246"><enum>(C)</enum><text>The health care professional that provides the items or services involved in the denial.</text></subparagraph> <subparagraph id="H0433BB7CB2DC4D80BA3E24A0EBFF44EE"><enum>(D)</enum><text>The institution at which the items or services (or treatment) involved in the denial are provided.</text></subparagraph> <subparagraph id="H593EC25C202040E5BD7F513E2FD18292"><enum>(E)</enum><text>The manufacturer of any drug or other item that is included in the items or services involved in the denial.</text></subparagraph> <subparagraph id="H124E6A0D034B4F0CBFAB9F4F5DF9A01D"><enum>(F)</enum><text>Any other party determined under any regulations to have a substantial interest in the denial involved.</text></subparagraph></paragraph></subsection> <subsection id="H091A86CBA3A643C0B072F1061EF121A0"><enum>(h)</enum><header>Qualified external review entities</header> <paragraph id="HAAF093FAE81147FB8C27B539076BEBCB"><enum>(1)</enum><header>Selection of qualified external review entities</header> <subparagraph id="HC892B27C5E6A402486FA0795727BA071"><enum>(A)</enum><header>Limitation on plan or issuer selection</header><text>The appropriate Secretary shall implement procedures—</text> <clause id="H02DCD7346A1B430C00B819F6461F54C"><enum>(i)</enum><text>to assure that the selection process among qualified external review entities will not create any incentives for external review entities to make a decision in a biased manner; and</text></clause> <clause id="H8A0FD23884794B0CA2D82193C421CB3"><enum>(ii)</enum><text>for auditing a sample of decisions by such entities to assure that no such decisions are made in a biased manner.</text></clause><continuation-text continuation-text-level="subparagraph">No such selection process under the procedures implemented by the appropriate Secretary may give either the patient or the plan or issuer any ability to determine or influence the selection of a qualified external review entity to review the case of any participant, beneficiary, or enrollee.</continuation-text></subparagraph> <subparagraph id="H86FB7CD57E7C4A66885D1BC461CDC44"><enum>(B)</enum><header>State authority with respect to qualified external review entities for health insurance issuers</header><text>With respect to health insurance issuers offering health insurance coverage in a State, the State may provide for external review activities to be conducted by a qualified external appeal entity that is designated by the State or that is selected by the State in a manner determined by the State to assure an unbiased determination.</text></subparagraph></paragraph> <paragraph id="H8FA6C1D7321B480794C43300DD46B5E"><enum>(2)</enum><header>Contract with qualified external review entity</header><text>Except as provided in paragraph (1)(B), the external review process of a plan or issuer under this section shall be conducted under a contract between the plan or issuer and 1 or more qualified external review entities (as defined in paragraph (4)(A)).</text></paragraph> <paragraph id="H74DE1ADB7731409C90D5E6BE27153E4D"><enum>(3)</enum><header>Terms and conditions of contract</header><text>The terms and conditions of a contract under paragraph (2) shall—</text> <subparagraph id="H4E653EC6DCEE47D3B25707DD8D05C662"><enum>(A)</enum><text>be consistent with the standards the appropriate Secretary shall establish to assure there is no real or apparent conflict of interest in the conduct of external review activities; and</text></subparagraph> <subparagraph id="HB4E7D0830E864ED48880B9F944AC009E"><enum>(B)</enum><text>provide that the costs of the external review process shall be borne by the plan or issuer.</text></subparagraph><continuation-text continuation-text-level="paragraph">Subparagraph (B) shall not be construed as applying to the imposition of a filing fee under subsection (b)(2)(A)(iv) or costs incurred by the participant, beneficiary, or enrollee (or authorized representative) or treating health care professional (if any) in support of the review, including the provision of additional evidence or information.</continuation-text></paragraph> <paragraph id="HE6FBBC4FE7B04EC98993FDAEE59F937"><enum>(4)</enum><header>Qualifications</header> <subparagraph id="H24D9E448253044EEB5CAF59606491657"><enum>(A)</enum><header>In general</header><text>In this section, the term <term>qualified external review entity</term> means, in relation to a plan or issuer, an entity that is initially certified (and periodically recertified) under subparagraph (C) as meeting the following requirements:</text> <clause id="HBBE34CB80B1F41B4B9D88FAF00E2954"><enum>(i)</enum><text>The entity has (directly or through contracts or other arrangements) sufficient medical, legal, and other expertise and sufficient staffing to carry out duties of a qualified external review entity under this section on a timely basis, including making determinations under subsection (b)(2)(A) and providing for independent medical reviews under subsection (d).</text></clause> <clause id="H7DAA7E5C3A024A168F4D34FE106CE22B"><enum>(ii)</enum><text>The entity is not a plan or issuer or an affiliate or a subsidiary of a plan or issuer, and is not an affiliate or subsidiary of a professional or trade association of plans or issuers or of health care providers.</text></clause> <clause id="H0F4A8152134B4008BEECC5DDE04CBC54"><enum>(iii)</enum><text>The entity has provided assurances that it will conduct external review activities consistent with the applicable requirements of this section and standards specified in subparagraph (C), including that it will not conduct any external review activities in a case unless the independence requirements of subparagraph (B) are met with respect to the case.</text></clause> <clause id="HDACCF82B25044A6FB8B4A83591B5000"><enum>(iv)</enum><text>The entity has provided assurances that it will provide information in a timely manner under subparagraph (D).</text></clause> <clause id="HC029085733E9409C81A94069A7CE9E1D"><enum>(v)</enum><text>The entity meets such other requirements as the appropriate Secretary provides by regulation.</text></clause></subparagraph> <subparagraph id="H92B89E6D6DF24DFB87CA9B2BF34655D6"><enum>(B)</enum><header>Independence requirements</header> <clause id="H0E59AD6BC5794882B8ACB973D8AB2631"><enum>(i)</enum><header>In general</header><text>Subject to clause (ii), an entity meets the independence requirements of this subparagraph with respect to any case if the entity—</text> <subclause id="H01CBD52463D54240B239A783D7004D01"><enum>(I)</enum><text>is not a related party (as defined in subsection (g)(7));</text></subclause> <subclause id="HA5A004DFD74A4DDBB2D9ACCE5BE0A7E9"><enum>(II)</enum><text>does not have a material familial, financial, or professional relationship with such a party; and</text></subclause> <subclause id="H9CCEDCE6E9B04A7985E5DE73F5E800F4"><enum>(III)</enum><text>does not otherwise have a conflict of interest with such a party (as determined under regulations).</text></subclause></clause> <clause id="H4E74D21CDA6741E9AA00D7972B74783B"><enum>(ii)</enum><header>Exception for reasonable compensation</header><text>Nothing in clause (i) shall be construed to prohibit receipt by a qualified external review entity of compensation from a plan or issuer for the conduct of external review activities under this section if the compensation is provided consistent with clause (iii).</text></clause> <clause id="H6A321FC12E214DC9A0544300BA01F436"><enum>(iii)</enum><header>Limitations on entity compensation</header><text>Compensation provided by a plan or issuer to a qualified external review entity in connection with reviews under this section shall—</text> <subclause id="H166EF2767C1041219129FB46002E1C8C"><enum>(I)</enum><text>not exceed a reasonable level; and</text></subclause> <subclause id="HF587044494414170A4E4967EEBC2ADAB"><enum>(II)</enum><text>not be contingent on any decision rendered by the entity or by any independent medical reviewer.</text></subclause></clause></subparagraph> <subparagraph id="H4B9EF0F83BAF49BC9000408B833635CA"><enum>(C)</enum><header>Certification and recertification process</header> <clause id="H5E4339D2B568488E8F4F038DE8BD1770"><enum>(i)</enum><header>In general</header><text>The initial certification and recertification of a qualified external review entity shall be made—</text> <subclause id="HD8E47356FB8E40FCAEC28440AAA77735"><enum>(I)</enum><text>under a process that is recognized or approved by the appropriate Secretary; or</text></subclause> <subclause id="HEC8DD26952C8410FA24523259DE3F3DD"><enum>(II)</enum><text>by a qualified private standard-setting organization that is approved by the appropriate Secretary under clause (iii).</text></subclause><continuation-text continuation-text-level="clause">In taking action under subclause (I), the appropriate Secretary shall give deference to entities that are under contract with the Federal Government or with an applicable State authority to perform functions of the type performed by qualified external review entities.</continuation-text></clause> <clause id="HCDE7DFB16899412A96BEBFCB971BCFFF"><enum>(ii)</enum><header>Process</header><text>The appropriate Secretary shall not recognize or approve a process under clause (i)(I) unless the process applies standards (as promulgated in regulations) that ensure that a qualified external review entity—</text> <subclause id="H1969C769B97C439900001F4D85C09200"><enum>(I)</enum><text>will carry out (and has carried out, in the case of recertification) the responsibilities of such an entity in accordance with this section, including meeting applicable deadlines;</text></subclause> <subclause id="HA1A4FF2C3EC94E9ABB796C902BCE5CA8"><enum>(II)</enum><text>will meet (and has met, in the case of recertification) appropriate indicators of fiscal integrity;</text></subclause> <subclause id="H2BE89C6CBFCC47F7BEFBCB285FCA7A1"><enum>(III)</enum><text>will maintain (and has maintained, in the case of recertification) appropriate confidentiality with respect to individually identifiable health information obtained in the course of conducting external review activities; and</text></subclause> <subclause id="H89F152279DD446F99502A81CF351C75C"><enum>(IV)</enum><text>in the case of recertification, shall review the matters described in clause (iv).</text></subclause></clause> <clause id="HDE7B807F2C7C402FAE8F0001936D7BE7"><enum>(iii)</enum><header>Approval of qualified private standard-setting organizations</header><text>For purposes of clause (i)(II), the appropriate Secretary may approve a qualified private standard-setting organization if such Secretary finds that the organization only certifies (or recertifies) external review entities that meet at least the standards required for the certification (or recertification) of external review entities under clause (ii).</text></clause> <clause id="H603106E90A074847AA5E63B883EB313"><enum>(iv)</enum><header>Considerations in recertifications</header><text>In conducting recertifications of a qualified external review entity under this paragraph, the appropriate Secretary or organization conducting the recertification shall review compliance of the entity with the requirements for conducting external review activities under this section, including the following:</text> <subclause id="H15E64757D6B74AD89F659017529CA995"><enum>(I)</enum><text>Provision of information under subparagraph (D).</text></subclause> <subclause id="H1D227894622C45ABB057E69F00003112"><enum>(II)</enum><text>Adherence to applicable deadlines (both by the entity and by independent medical reviewers it refers cases to).</text></subclause> <subclause id="HA3C854BEE082493C897BFD243577703E"><enum>(III)</enum><text>Compliance with limitations on compensation (with respect to both the entity and independent medical reviewers it refers cases to).</text></subclause> <subclause id="HEA8A65DABD1C430794419D57C6964F48"><enum>(IV)</enum><text>Compliance with applicable independence requirements.</text></subclause> <subclause id="HF9366A3208944026B0478081FB703B"><enum>(V)</enum><text>Compliance with the requirement of subsection (d)(1) that only medically reviewable decisions shall be the subject of independent medical review and with the requirement of subsection (d)(3) that independent medical reviewers may not require coverage for specifically excluded benefits.</text></subclause></clause> <clause id="H3C0FF485280040CE92F2AAE4069DF4D4"><enum>(v)</enum><header>Period of certification or recertification</header><text>A certification or recertification provided under this paragraph shall extend for a period not to exceed 2 years.</text></clause> <clause id="H0DD807FE5BA34B7DB8DD42FCB5D8B81F"><enum>(vi)</enum><header>Revocation</header><text>A certification or recertification under this paragraph may be revoked by the appropriate Secretary or by the organization providing such certification upon a showing of cause. The Secretary, or organization, shall revoke a certification or deny a recertification with respect to an entity if there is a showing that the entity has a pattern or practice of ordering coverage for benefits that are specifically excluded under the plan or coverage.</text></clause> <clause id="HCE8978BC6BE04BF19EE2752546E4008D"><enum>(vii)</enum><header>Petition for denial or withdrawal</header><text>An individual may petition the Secretary, or an organization providing the certification involves, for a denial of recertification or a withdrawal of a certification with respect to an entity under this subparagraph if there is a pattern or practice of such entity failing to meet a requirement of this section.</text></clause> <clause id="H59A5131A075342DF9C820999B400921C"><enum>(viii)</enum><header>Sufficient number of entities</header><text>The appropriate Secretary shall certify and recertify a number of external review entities which is sufficient to ensure the timely and efficient provision of review services.</text></clause></subparagraph> <subparagraph id="H960DCA3D10DD4206AF9311D104A5C72"><enum>(D)</enum><header>Provision of information</header> <clause id="H024480AE44954096A03627DD004FCF7D"><enum>(i)</enum><header>In general</header><text>A qualified external review entity shall provide to the appropriate Secretary, in such manner and at such times as such Secretary may require, such information (relating to the denials which have been referred to the entity for the conduct of external review under this section) as such Secretary determines appropriate to assure compliance with the independence and other requirements of this section to monitor and assess the quality of its external review activities and lack of bias in making determinations. Such information shall include information described in clause (ii) but shall not include individually identifiable medical information.</text></clause> <clause id="HB8C83588C2784AB3B62E3CF651594F96"><enum>(ii)</enum><header>Information to be included</header><text>The information described in this subclause with respect to an entity is as follows:</text> <subclause id="H6C6EAAEDEFEF462F87B7A1DF326F915B"><enum>(I)</enum><text>The number and types of denials for which a request for review has been received by the entity.</text></subclause> <subclause id="H0A739A9D18A14156BDC1639984E89D7C"><enum>(II)</enum><text>The disposition by the entity of such denials, including the number referred to a independent medical reviewer and the reasons for such dispositions (including the application of exclusions), on a plan or issuer-specific basis and on a health care specialty-specific basis.</text></subclause> <subclause id="H61F5CA021DF047878FD7D1F7DAC4F13"><enum>(III)</enum><text>The length of time in making determinations with respect to such denials.</text></subclause> <subclause id="HF2FB071592F64D34B5BE5FDEEADC24FC"><enum>(IV)</enum><text>Updated information on the information required to be submitted as a condition of certification with respect to the entity’s performance of external review activities.</text></subclause></clause> <clause id="H7E93656892D54F9CA7205768A86920E1"><enum>(iii)</enum><header>Information to be provided to certifying organization</header> <subclause id="HD755390F25274B61A187A803FE37EA15"><enum>(I)</enum><header>In general</header><text>In the case of a qualified external review entity which is certified (or recertified) under this subsection by a qualified private standard-setting organization, at the request of the organization, the entity shall provide the organization with the information provided to the appropriate Secretary under clause (i).</text></subclause> <subclause id="H1D9405F4917F4B9EBE12C7BC930067AC"><enum>(II)</enum><header>Additional information</header><text>Nothing in this subparagraph shall be construed as preventing such an organization from requiring additional information as a condition of certification or recertification of an entity.</text></subclause></clause> <clause id="HB36178C6DA844F419B9DA81CF8FD37A0"><enum>(iv)</enum><header>Use of information</header><text>Information provided under this subparagraph may be used by the appropriate Secretary and qualified private standard-setting organizations to conduct oversight of qualified external review entities, including recertification of such entities, and shall be made available to the public in an appropriate manner.</text></clause></subparagraph> <subparagraph id="HB1D7D680C79D44C19522D6FBCB23DE0"><enum>(E)</enum><header>Limitation on liability</header><text>No qualified external review entity having a contract with a plan or issuer, and no person who is employed by any such entity or who furnishes professional services to such entity (including as an independent medical reviewer), shall be held by reason of the performance of any duty, function, or activity required or authorized pursuant to this section, to be civilly liable under any law of the United States or of any State (or political subdivision thereof) if there was no actual malice or gross misconduct in the performance of such duty, function, or activity.</text></subparagraph></paragraph> <paragraph id="H49C9B7651EAE4396B01088ADD4EEF404"><enum>(5)</enum><header>Report</header><text>Not later than 12 months after the general effective date referred to in section 601, the General Accounting Office shall prepare and submit to the appropriate committees of Congress a report concerning—</text> <subparagraph id="HF120A56363FD474AA03DB42EBAACEDE2"><enum>(A)</enum><text>the information that is provided under paragraph (3)(D);</text></subparagraph> <subparagraph id="H9E353875F1EC4A96B5F3728D1DA67453"><enum>(B)</enum><text>the number of denials that have been upheld by independent medical reviewers and the number of denials that have been reversed by such reviewers; and</text></subparagraph> <subparagraph id="HE971E63B70DB4DFB00C0D5D238466E11"><enum>(C)</enum><text>the extent to which independent medical reviewers are requiring coverage for benefits that are specifically excluded under the plan or coverage.</text></subparagraph></paragraph></subsection></section> <section id="HF94D2D34841C45E29F04B85309AAE500"><enum>105.</enum><header>Health Care Consumer Assistance Fund</header> <subsection id="H62885672B5374EF7B04973710012C82F"><enum>(a)</enum><header>Grants</header> <paragraph id="HEE49CF0BCBDC4A35965BF1FA71F6D5AA"><enum>(1)</enum><header>In general</header><text>The Secretary of Health and Human Services (referred to in this section as the <quote>Secretary</quote>) shall establish a fund, to be known as the <quote>Health Care Consumer Assistance Fund</quote>, to be used to award grants to eligible States to carry out consumer assistance activities (including programs established by States prior to the enactment of this Act) designed to provide information, assistance, and referrals to consumers of health insurance products.</text></paragraph> <paragraph id="HEEBF446C5F384207AB14FC005C7478AA"><enum>(2)</enum><header>State eligibility</header><text>To be eligible to receive a grant under this subsection a State shall prepare and submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require, including a State plan that describes—</text> <subparagraph id="HFFE52C6BFFF34D538DDB934856191D87"><enum>(A)</enum><text>the manner in which the State will ensure that the health care consumer assistance office (established under paragraph (4)) will educate and assist health care consumers in accessing needed care;</text></subparagraph> <subparagraph id="H5433E6F7AEEB402B986697ABB47F139"><enum>(B)</enum><text>the manner in which the State will coordinate and distinguish the services provided by the health care consumer assistance office with the services provided by Federal, State and local health-related ombudsman, information, protection and advocacy, insurance, and fraud and abuse programs;</text></subparagraph> <subparagraph id="HC760735528EE4C60854535DC42B46E9D"><enum>(C)</enum><text>the manner in which the State will provide information, outreach, and services to underserved, minority populations with limited English proficiency and populations residing in rural areas;</text></subparagraph> <subparagraph id="H1F93A1FB40454BF58D41B177782A079"><enum>(D)</enum><text>the manner in which the State will oversee the health care consumer assistance office, its activities, product materials and evaluate program effectiveness;</text></subparagraph> <subparagraph id="H4AA2032FA5CE4554BCA351637F38C900"><enum>(E)</enum><text>the manner in which the State will ensure that funds made available under this section will be used to supplement, and not supplant, any other Federal, State, or local funds expended to provide services for programs described under this section and those described in subparagraphs (C) and (D);</text></subparagraph> <subparagraph id="H72D9FDCDD9D444D79937A06C5DE4732D"><enum>(F)</enum><text>the manner in which the State will ensure that health care consumer office personnel have the professional background and training to carry out the activities of the office; and</text></subparagraph> <subparagraph id="HAF8E00DA1776467CA6D15217DEFFE5D4"><enum>(G)</enum><text>the manner in which the State will ensure that consumers have direct access to consumer assistance personnel during regular business hours.</text></subparagraph></paragraph> <paragraph id="HC392EA4A71AB4081A700D45E43AF9848"><enum>(3)</enum><header>Amount of grant</header> <subparagraph id="H75A0E200F31941C7B5C484F184A6F9F"><enum>(A)</enum><header>In general</header><text>From amounts appropriated under subsection (b) for a fiscal year, the Secretary shall award a grant to a State in an amount that bears the same ratio to such amounts as the number of individuals within the State covered under a group health plan or under health insurance coverage offered by a health insurance issuer bears to the total number of individuals so covered in all States (as determined by the Secretary). Any amounts provided to a State under this subsection that are not used by the State shall be remitted to the Secretary and reallocated in accordance with this subparagraph.</text></subparagraph> <subparagraph id="H4BAAB082564D447D809901591C407E4B"><enum>(B)</enum><header>Minimum amount</header><text>In no case shall the amount provided to a State under a grant under this subsection for a fiscal year be less than an amount equal to 0.5 percent of the amount appropriated for such fiscal year to carry out this section.</text></subparagraph> <subparagraph id="HEC1B6295EB974A7D90BFD748B1BB56F4"><enum>(C)</enum><header>Non-federal contributions</header><text>A State will provide for the collection of non-Federal contributions for the operation of the office in an amount that is not less than 25 percent of the amount of Federal funds provided to the State under this section.</text></subparagraph></paragraph> <paragraph id="H54A5124D7FFF4229B40037851450F49E"><enum>(4)</enum><header>Provision of funds for establishment of office</header> <subparagraph id="H1B6026CB63704A31B2D10681CC51F44"><enum>(A)</enum><header>In general</header><text>From amounts provided under a grant under this subsection, a State shall, directly or through a contract with an independent, nonprofit entity with demonstrated experience in serving the needs of health care consumers, provide for the establishment and operation of a State health care consumer assistance office.</text></subparagraph> <subparagraph id="HD26DDFDCCA1F4ECC948F9941F478BCA6"><enum>(B)</enum><header>Eligibility of entity</header><text>To be eligible to enter into a contract under subparagraph (A), an entity shall demonstrate that it has the technical, organizational, and professional capacity to deliver the services described in subsection (b) to all public and private health insurance participants, beneficiaries, enrollees, or prospective enrollees.</text></subparagraph> <subparagraph id="HC34F90B150EF4CF2AA4FF986A5FDAC8D"><enum>(C)</enum><header>Existing State entity</header><text>Nothing in this section shall prevent the funding of an existing health care consumer assistance program that otherwise meets the requirements of this section.</text></subparagraph></paragraph></subsection> <subsection id="HF19F3AC4571143E48733CBAC5E46E3D3"><enum>(b)</enum><header>Use of funds</header> <paragraph id="HFA67DB39B2E446B5B4CEE7F4C330CB1"><enum>(1)</enum><header>By State</header><text>A State shall use amounts provided under a grant awarded under this section to carry out consumer assistance activities directly or by contract with an independent, non-profit organization. An eligible entity may use some reasonable amount of such grant to ensure the adequate training of personnel carrying out such activities. To receive amounts under this subsection, an eligible entity shall provide consumer assistance services, including—</text> <subparagraph id="H03D2D3A1A1A64897A9C3A0B399052E04"><enum>(A)</enum><text>the operation of a toll-free telephone hotline to respond to consumer requests;</text></subparagraph> <subparagraph id="H23647D1951A24936A543A1C18787441B"><enum>(B)</enum><text>the dissemination of appropriate educational materials on available health insurance products and on how best to access health care and the rights and responsibilities of health care consumers;</text></subparagraph> <subparagraph id="H521DF26AC3ED461DA61DD91E1160E7C3"><enum>(C)</enum><text>the provision of education on effective methods to promptly and efficiently resolve questions, problems, and grievances;</text></subparagraph> <subparagraph id="H03D4B511A5B744FCB8D608F42620470"><enum>(D)</enum><text>the coordination of educational and outreach efforts with health plans, health care providers, payers, and governmental agencies;</text></subparagraph> <subparagraph id="HCB0B70B5B285454A81770062F2A667F8"><enum>(E)</enum><text>referrals to appropriate private and public entities to resolve questions, problems and grievances; and</text></subparagraph> <subparagraph id="H86F099549CA04FC8A23B747184CC4556"><enum>(F)</enum><text>the provision of information and assistance, including acting as an authorized representative, regarding internal, external, or administrative grievances or appeals procedures in nonlitigative settings to appeal the denial, termination, or reduction of health care services, or the refusal to pay for such services, under a group health plan or health insurance coverage offered by a health insurance issuer.</text></subparagraph></paragraph> <paragraph id="H6ECE2ACCB1FD4E9DBC9FE7361251EB2"><enum>(2)</enum><header>Confidentiality and access to information</header> <subparagraph id="H08B058DFD45849A2966FCABCCFF8FC00"><enum>(A)</enum><header>State entity</header><text>With respect to a State that directly establishes a health care consumer assistance office, such office shall establish and implement procedures and protocols in accordance with applicable Federal and State laws.</text></subparagraph> <subparagraph id="H00BCEE40DB4844BA9C545B85003CACDA"><enum>(B)</enum><header>Contract entity</header><text>With respect to a State that, through contract, establishes a health care consumer assistance office, such office shall establish and implement procedures and protocols, consistent with applicable Federal and State laws, to ensure the confidentiality of all information shared by a participant, beneficiary, enrollee, or their personal representative and their health care providers, group health plans, or health insurance insurers with the office and to ensure that no such information is used by the office, or released or disclosed to State agencies or outside persons or entities without the prior written authorization (in accordance with <external-xref legal-doc="regulation" parsable-cite="cfr/45/164.508">section 164.508</external-xref> of title 45, Code of Federal Regulations) of the individual or personal representative. The office may, consistent with applicable Federal and State confidentiality laws, collect, use or disclose aggregate information that is not individually identifiable (as defined in <external-xref legal-doc="regulation" parsable-cite="cfr/45/164.501">section 164.501</external-xref> of title 45, Code of Federal Regulations). The office shall provide a written description of the policies and procedures of the office with respect to the manner in which health information may be used or disclosed to carry out consumer assistance activities. The office shall provide health care providers, group health plans, or health insurance issuers with a written authorization (in accordance with <external-xref legal-doc="regulation" parsable-cite="cfr/45/164.508">section 164.508</external-xref> of title 45, Code of Federal Regulations) to allow the office to obtain medical information relevant to the matter before the office.</text></subparagraph></paragraph> <paragraph id="HF3ACD620682644058895E5C6472124D8"><enum>(3)</enum><header>Availability of services</header><text>The health care consumer assistance office of a State shall not discriminate in the provision of information, referrals, and services regardless of the source of the individual’s health insurance coverage or prospective coverage, including individuals covered under a group health plan or health insurance coverage offered by a health insurance issuer, the medicare or medicaid programs under title XVIII or XIX of the <act-name parsable-cite="SSA">Social Security Act</act-name> (42 U.S.C. 1395 and 1396 et seq.), or under any other Federal or State health care program.</text></paragraph> <paragraph id="HF3636DD7E49B42E1BE47D2E395ED8DF7"><enum>(4)</enum><header>Designation of responsibilities</header> <subparagraph id="HAC886085E22541E083E989608F61AC96"><enum>(A)</enum><header>Within existing State entity</header><text>If the health care consumer assistance office of a State is located within an existing State regulatory agency or office of an elected State official, the State shall ensure that—</text> <clause id="H30305EAAD309404DB4F19FB758737FC1"><enum>(i)</enum><text>there is a separate delineation of the funding, activities, and responsibilities of the office as compared to the other funding, activities, and responsibilities of the agency; and</text></clause> <clause id="HFE9452EC674A4AB283FE2772A69DEF29"><enum>(ii)</enum><text>the office establishes and implements procedures and protocols to ensure the confidentiality of all information shared by a participant, beneficiary, or enrollee or their personal representative and their health care providers, group health plans, or health insurance issuers with the office and to ensure that no information is disclosed to the State agency or office without the written authorization of the individual or their personal representative in accordance with paragraph (2).</text></clause></subparagraph> <subparagraph id="HEAA2C18ABC6A494D8C096006ECA646E"><enum>(B)</enum><header>Contract entity</header><text>In the case of an entity that enters into a contract with a State under subsection (a)(3), the entity shall provide assurances that the entity has no conflict of interest in carrying out the activities of the office and that the entity is independent of group health plans, health insurance issuers, providers, payers, and regulators of health care.</text></subparagraph></paragraph> <paragraph id="HD63699108D284249AD2E8C39671BBDE"><enum>(5)</enum><header>Subcontracts</header><text>The health care consumer assistance office of a State may carry out activities and provide services through contracts entered into with 1 or more nonprofit entities so long as the office can demonstrate that all of the requirements of this section are complied with by the office.</text></paragraph> <paragraph id="H4027E2F6EE564E659C003DFEFB3940C8"><enum>(6)</enum><header>Term</header><text>A contract entered into under this subsection shall be for a term of 3 years.</text></paragraph></subsection> <subsection id="H03886CA19B2F464692D0B4FF68644A1"><enum>(c)</enum><header>Report</header><text>Not later than 1 year after the Secretary first awards grants under this section, and annually thereafter, the Secretary shall prepare and submit to the appropriate committees of Congress a report concerning the activities funded under this section and the effectiveness of such activities in resolving health care-related problems and grievances.</text></subsection> <subsection id="H9BAB144387FF45C181CF01B600789C9F"><enum>(d)</enum><header>Authorization of appropriations</header><text>There are authorized to be appropriated such sums as may be necessary to carry out this section.</text></subsection></section></subtitle> <subtitle id="HC3D60C563041447798C534895479CDD9"><enum>B</enum><header>Access to care</header> <section id="H58965AD711F54A099C1B3CB772536401"><enum>111.</enum><header>Consumer choice option</header> <subsection id="HBD9F9C21F017416F9FA4A156853BDDB4"><enum>(a)</enum><header>In general</header><text>If—</text> <paragraph id="H149876F943B64D98B91B3506C9B7CA1"><enum>(1)</enum><text>a health insurance issuer providing health insurance coverage in connection with a group health plan offers to enrollees health insurance coverage which provides for coverage of services (including physician pathology services) only if such services are furnished through health care professionals and providers who are members of a network of health care professionals and providers who have entered into a contract with the issuer to provide such services, or</text></paragraph> <paragraph id="H22A2495279524CD6B0499D3F79EEB91D"><enum>(2)</enum><text>a group health plan offers to participants or beneficiaries health benefits which provide for coverage of services only if such services are furnished through health care professionals and providers who are members of a network of health care professionals and providers who have entered into a contract with the plan to provide such services,</text></paragraph><continuation-text continuation-text-level="subsection">then the issuer or plan shall also offer or arrange to be offered to such enrollees, participants, or beneficiaries (at the time of enrollment and during an annual open season as provided under subsection (c)) the option of health insurance coverage or health benefits which provide for coverage of such services which are not furnished through health care professionals and providers who are members of such a network unless such enrollees, participants, or beneficiaries are offered such non-network coverage through another group health plan or through another health insurance issuer in the group market.</continuation-text></subsection> <subsection id="H4123301563D4418BAC5BBE4D001BD810"><enum>(b)</enum><header>Additional costs</header><text>The amount of any additional premium charged by the health insurance issuer or group health plan for the additional cost of the creation and maintenance of the option described in subsection (a) and the amount of any additional cost sharing imposed under such option shall be borne by the enrollee, participant, or beneficiary unless it is paid by the health plan sponsor or group health plan through agreement with the health insurance issuer.</text></subsection> <subsection id="H89CF048E01824480BA7789485D880086"><enum>(c)</enum><header>Open season</header><text>An enrollee, participant, or beneficiary, may change to the offering provided under this section only during a time period determined by the health insurance issuer or group health plan. Such time period shall occur at least annually.</text></subsection></section> <section id="H62A679B9D8484F63B4E4D7177BEE32D"><enum>112.</enum><header>Choice of health care professional</header> <subsection id="HA641463AA48F492A9E426FCA2393B998"><enum>(a)</enum><header>Primary care</header><text>If a group health plan, or a health insurance issuer that offers health insurance coverage, requires or provides for designation by a participant, beneficiary, or enrollee of a participating primary care provider, then the plan or issuer shall permit each participant, beneficiary, and enrollee to designate any participating primary care provider who is available to accept such individual.</text></subsection> <subsection id="H6740C56BF4F1430784A4B19FDAF9255D"><enum>(b)</enum><header>Specialists</header> <paragraph id="HF09BA2E1537945AC89B25BA176FE0009"><enum>(1)</enum><header>In general</header><text>Subject to paragraph (2), a group health plan and a health insurance issuer that offers health insurance coverage shall permit each participant, beneficiary, or enrollee to receive medically necessary and appropriate specialty care, pursuant to appropriate referral procedures, from any qualified participating health care professional who is available to accept such individual for such care.</text></paragraph> <paragraph id="HA12CDC1D1842459F9D2B44DA7FB574FE"><enum>(2)</enum><header>Limitation</header><text>Paragraph (1) shall not apply to specialty care if the plan or issuer clearly informs participants, beneficiaries, and enrollees of the limitations on choice of participating health care professionals with respect to such care.</text></paragraph> <paragraph id="H9C487A469F4849CCB22E5F56871FD8FA"><enum>(3)</enum><header>Construction</header><text>Nothing in this subsection shall be construed as affecting the application of section 114 (relating to access to specialty care).</text></paragraph></subsection></section> <section id="H8547821D0CFA4C25BAD277968C348708"><enum>113.</enum><header>Access to emergency care</header> <subsection id="H2B589B7BDDE341498E00598D317D09EA"><enum>(a)</enum><header>Coverage of emergency services</header> <paragraph id="H175F50D9B219438A9F22C5977757C29C"><enum>(1)</enum><header>In general</header><text>If a group health plan, or health insurance coverage offered by a health insurance issuer, provides or covers any benefits with respect to services in an emergency department of a hospital, the plan or issuer shall cover emergency services (as defined in paragraph (2)(B))—</text> <subparagraph id="H1AB3566B95324C31BD167EB56B34E0C0"><enum>(A)</enum><text>without the need for any prior authorization determination;</text></subparagraph> <subparagraph id="HA12A5A89E3624DB0A89E03100855EAAE"><enum>(B)</enum><text>whether the health care provider furnishing such services is a participating provider with respect to such services;</text></subparagraph> <subparagraph id="HA7180011CA6F4544B008CD7BBCE13C93"><enum>(C)</enum><text>in a manner so that, if such services are provided to a participant, beneficiary, or enrollee—</text> <clause id="HF2AF9BBEFCD2440DA8726674FA19EF2C"><enum>(i)</enum><text>by a nonparticipating health care provider with or without prior authorization, or</text></clause> <clause id="HAE6D24286F474769AC13159FCB66B1B"><enum>(ii)</enum><text>by a participating health care provider without prior authorization,</text></clause><continuation-text continuation-text-level="subparagraph">the participant, beneficiary, or enrollee is not liable for amounts that exceed the amounts of liability that would be incurred if the services were provided by a participating health care provider with prior authorization; and</continuation-text></subparagraph> <subparagraph id="H2FFF318632D3478391AA08BED31225C"><enum>(D)</enum><text>without regard to any other term or condition of such coverage (other than exclusion or coordination of benefits, or an affiliation or waiting period, permitted under section 2701 of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name>, section 701 of the <act-name parsable-cite="ERISA">Employee Retirement Income Security Act of 1974</act-name>, or <external-xref legal-doc="usc" parsable-cite="usc/26/9801">section 9801</external-xref> of the Internal Revenue Code of 1986, and other than applicable cost-sharing).</text></subparagraph></paragraph> <paragraph id="HB01F1011781F4F0CA861CAD7D3435373"><enum>(2)</enum><header>Definitions</header><text>In this section:</text> <subparagraph id="H7ED5F15039F8439181B07EF674C94856"><enum>(A)</enum><header>Emergency medical condition</header><text>The term <term>emergency medical condition</term> means a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that a prudent layperson, who possesses an average knowledge of health and medicine, could reasonably expect the absence of immediate medical attention to result in a condition described in clause (i), (ii), or (iii) of section 1867(e)(1)(A) of the <act-name parsable-cite="SSA">Social Security Act</act-name>.</text></subparagraph> <subparagraph id="H7D32B2FDFCAA4F1AA699E800DF9132D3"><enum>(B)</enum><header>Emergency services</header><text>The term <term>emergency services</term> means, with respect to an emergency medical condition—</text> <clause id="H57B09A4F20E744A6A9809942BC5BF1F6"><enum>(i)</enum><text>a medical screening examination (as required under section 1867 of the <act-name parsable-cite="SSA">Social Security Act</act-name>) that is within the capability of the emergency department of a hospital, including ancillary services routinely available to the emergency department to evaluate such emergency medical condition, and</text></clause> <clause id="H46013CB66EF44053A44D532959580320"><enum>(ii)</enum><text>within the capabilities of the staff and facilities available at the hospital, such further medical examination and treatment as are required under section 1867 of such Act to stabilize the patient.</text></clause></subparagraph> <subparagraph id="HBEA612564D03479B97C4D8719BDD26BE"><enum>(C)</enum><header>Stabilize</header><text>The term <term>to stabilize</term>, with respect to an emergency medical condition (as defined in subparagraph (A)), has the meaning given in section 1867(e)(3) of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395dd">42 U.S.C. 1395dd(e)(3)</external-xref>).</text></subparagraph></paragraph></subsection> <subsection id="H66A6F2FBB9E04D839E22000939252815"><enum>(b)</enum><header>Reimbursement for maintenance care and post-stabilization care</header><text>A group health plan, and health insurance coverage offered by a health insurance issuer, must provide reimbursement for maintenance care and post-stabilization care in accordance with the requirements of section 1852(d)(2) of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-22">42 U.S.C. 1395w–22(d)(2)</external-xref>). Such reimbursement shall be provided in a manner consistent with subsection (a)(1)(C).</text></subsection> <subsection id="HD7233EF4E10F4812874DE0CE51F325AB"><enum>(c)</enum><header>Coverage of emergency ambulance services</header> <paragraph id="HA14FDC7A447D463CBB01546E96C108F2"><enum>(1)</enum><header>In general</header><text>If a group health plan, or health insurance coverage provided by a health insurance issuer, provides any benefits with respect to ambulance services and emergency services, the plan or issuer shall cover emergency ambulance services (as defined in paragraph (2)) furnished under the plan or coverage under the same terms and conditions under subparagraphs (A) through (D) of subsection (a)(1) under which coverage is provided for emergency services.</text></paragraph> <paragraph id="H26D875B3B25544B5B6D1F577FB3CBF55"><enum>(2)</enum><header>Emergency ambulance services</header><text>For purposes of this subsection, the term <term>emergency ambulance services</term> means ambulance services (as defined for purposes of section 1861(s)(7) of the <act-name parsable-cite="SSA">Social Security Act</act-name>) furnished to transport an individual who has an emergency medical condition (as defined in subsection (a)(2)(A)) to a hospital for the receipt of emergency services (as defined in subsection (a)(2)(B)) in a case in which the emergency services are covered under the plan or coverage pursuant to subsection (a)(1) and a prudent layperson, with an average knowledge of health and medicine, could reasonably expect that the absence of such transport would result in placing the health of the individual in serious jeopardy, serious impairment of bodily function, or serious dysfunction of any bodily organ or part.</text></paragraph></subsection></section> <section id="H5B6A3E0C861249EE8CCE36EE8B97D133"><enum>114.</enum><header>Timely access to specialists</header> <subsection id="H59CD4F89BB664E83B222EB5BBF80075"><enum>(a)</enum><header>Timely access</header> <paragraph id="H0D26B6DF112D4BE4B40130D4E42411D"><enum>(1)</enum><header>In general</header><text>A group health plan and a health insurance issuer offering health insurance coverage shall ensure that participants, beneficiaries, and enrollees receive timely access to specialists who are appropriate to the condition of, and accessible to, the participant, beneficiary, or enrollee, when such specialty care is a covered benefit under the plan or coverage.</text></paragraph> <paragraph id="H04C4FCA8B7AB47B086956D009999B195"><enum>(2)</enum><header>Rule of construction</header><text>Nothing in paragraph (1) shall be construed—</text> <subparagraph id="H06FA08E1576344A8A9EADB381249F27"><enum>(A)</enum><text>to require the coverage under a group health plan or health insurance coverage of benefits or services;</text></subparagraph> <subparagraph id="HE1C4048735FC46F28E661E38CCDFD7B2"><enum>(B)</enum><text>to prohibit a plan or issuer from including providers in the network only to the extent necessary to meet the needs of the plan’s or issuer’s participants, beneficiaries, or enrollees; or</text></subparagraph> <subparagraph id="H232135B698E64D65A4AE3413DED5C96"><enum>(C)</enum><text>to override any State licensure or scope-of-practice law.</text></subparagraph></paragraph> <paragraph id="HFCBCBD43D8264DB089C329CBFD2C886"><enum>(3)</enum><header>Access to certain providers</header> <subparagraph id="H85700C9CEF6B4D50801F89DF6BCE279C"><enum>(A)</enum><header>In general</header><text>With respect to specialty care under this section, if a participating specialist is not available and qualified to provide such care to the participant, beneficiary, or enrollee, the plan or issuer shall provide for coverage of such care by a nonparticipating specialist.</text></subparagraph> <subparagraph id="H74531A148E8944A1B8441300E4007841"><enum>(B)</enum><header>Treatment of nonparticipating providers</header><text>If a participant, beneficiary, or enrollee receives care from a nonparticipating specialist pursuant to subparagraph (A), such specialty care shall be provided at no additional cost to the participant, beneficiary, or enrollee beyond what the participant, beneficiary, or enrollee would otherwise pay for such specialty care if provided by a participating specialist.</text></subparagraph></paragraph></subsection> <subsection id="H86E55E4B0A6644E8B2A9ABB47772D443"><enum>(b)</enum><header>Referrals</header> <paragraph id="H89D4994DC2DA4D8AB643FBEBF3E60011"><enum>(1)</enum><header>Authorization</header><text>Subject to subsection (a)(1), a group health plan or health insurance issuer may require an authorization in order to obtain coverage for specialty services under this section. Any such authorization—</text> <subparagraph id="H1A4B2C116E774DC699004E7108992268"><enum>(A)</enum><text>shall be for an appropriate duration of time or number of referrals, including an authorization for a standing referral where appropriate; and</text></subparagraph> <subparagraph id="HE2954219A27E46E50088AA90C5DAE8B2"><enum>(B)</enum><text>may not be refused solely because the authorization involves services of a nonparticipating specialist (described in subsection (a)(3)).</text></subparagraph></paragraph> <paragraph id="H24617BC028E1461F9100F3B899FF09AC"><enum>(2)</enum><header>Referrals for ongoing special conditions</header> <subparagraph id="HD899B79326634997B9250019D625D9EB"><enum>(A)</enum><header>In general</header><text>Subject to subsection (a)(1), a group health plan and a health insurance issuer shall permit a participant, beneficiary, or enrollee who has an ongoing special condition (as defined in subparagraph (B)) to receive a referral to a specialist for the treatment of such condition and such specialist may authorize such referrals, procedures, tests, and other medical services with respect to such condition, or coordinate the care for such condition, subject to the terms of a treatment plan (if any) referred to in subsection (c) with respect to the condition.</text></subparagraph> <subparagraph id="H63E4561E5B6F4455A22EEB9590DE00F2"><enum>(B)</enum><header>Ongoing special condition defined</header><text>In this subsection, the term <term>ongoing special condition</term> means a condition or disease that—</text> <clause id="H557B8C6DFC46454C8E889C6C88B88019"><enum>(i)</enum><text>is life-threatening, degenerative, potentially disabling, or congenital; and</text></clause> <clause id="H44FC2B2FD0734DAE8772818CAA751E34"><enum>(ii)</enum><text>requires specialized medical care over a prolonged period of time.</text></clause></subparagraph></paragraph></subsection> <subsection id="H44B273189DD749E790687B6E63E5847C"><enum>(c)</enum><header>Treatment plans</header> <paragraph id="HA49E0D5A2C0E4DB6A7FED618D4F1515C"><enum>(1)</enum><header>In general</header><text>A group health plan or health insurance issuer may require that the specialty care be provided—</text> <subparagraph id="HCFEEF6CBDB424CC99541C63E683044CA"><enum>(A)</enum><text>pursuant to a treatment plan, but only if the treatment plan—</text> <clause id="H500C4FB70C29497893D67E8808003F84"><enum>(i)</enum><text>is developed by the specialist, in consultation with the case manager or primary care provider, and the participant, beneficiary, or enrollee, and</text></clause> <clause id="H3DDD1902A7964911A276CCBE05E115B8"><enum>(ii)</enum><text>is approved by the plan or issuer in a timely manner, if the plan or issuer requires such approval; and</text></clause></subparagraph> <subparagraph id="H983B1AF4121A4C2CB065E8BF44551315"><enum>(B)</enum><text>in accordance with applicable quality assurance and utilization review standards of the plan or issuer.</text></subparagraph></paragraph> <paragraph id="H04C2730CFD2D4E34B4A6BC274E91EC9C"><enum>(2)</enum><header>Notification</header><text>Nothing in paragraph (1) shall be construed as prohibiting a plan or issuer from requiring the specialist to provide the plan or issuer with regular updates on the specialty care provided, as well as all other reasonably necessary medical information.</text></paragraph></subsection> <subsection id="HE5346D7100FC44DA00C888803F625123"><enum>(d)</enum><header>Specialist defined</header><text>For purposes of this section, the term <term>specialist</term> means, with respect to the condition of the participant, beneficiary, or enrollee, a health care professional, facility, or center that has adequate expertise through appropriate training and experience (including, in the case of a child, appropriate pediatric expertise) to provide high quality care in treating the condition.</text></subsection></section> <section id="H908AC49B410B45BCAC718C8500F488F5"><enum>115.</enum><header>Patient access to obstetrical and gynecological care</header> <subsection id="HCB143BB49F7E4476B3B64777F44728A7"><enum>(a)</enum><header>General rights</header> <paragraph id="HF8CCE1EA0A54426189C3E16274FE133B"><enum>(1)</enum><header>Direct access</header><text>A group health plan, and a health insurance issuer offering health insurance coverage, described in subsection (b) may not require authorization or referral by the plan, issuer, or any person (including a primary care provider described in subsection (b)(2)) in the case of a female participant, beneficiary, or enrollee who seeks coverage for obstetrical or gynecological care provided by a participating health care professional who specializes in obstetrics or gynecology.</text></paragraph> <paragraph id="HCDFBC3F642CB44DD9B3D3CC614338BD7"><enum>(2)</enum><header>Obstetrical and gynecological care</header><text>A group health plan and a health insurance issuer described in subsection (b) shall treat the provision of obstetrical and gynecological care, and the ordering of related obstetrical and gynecological items and services, pursuant to the direct access described under paragraph (1), by a participating health care professional who specializes in obstetrics or gynecology as the authorization of the primary care provider.</text></paragraph></subsection> <subsection id="HAEE82AC137B04605AC29F569C8D09080"><enum>(b)</enum><header>Application of Section</header><text>A group health plan, or health insurance issuer offering health insurance coverage, described in this subsection is a group health plan or coverage that—</text> <paragraph id="H41A58D0BE97146779EE0A524D900DB17"><enum>(1)</enum><text>provides coverage for obstetric or gynecologic care; and</text></paragraph> <paragraph id="H040BD05C0ED64E85973D861478D54D96"><enum>(2)</enum><text>requires the designation by a participant, beneficiary, or enrollee of a participating primary care provider.</text></paragraph></subsection> <subsection id="HAA879858F9074D03BBE636B8007FD5C0"><enum>(c)</enum><header>Construction</header><text>Nothing in subsection (a) shall be construed to—</text> <paragraph id="HE7009D92CDDE48E900B37CF280C2AD50"><enum>(1)</enum><text>waive any exclusions of coverage under the terms and conditions of the plan or health insurance coverage with respect to coverage of obstetrical or gynecological care; or</text></paragraph> <paragraph id="H8622FC79E4BD4853A97B18C2C6B3547F"><enum>(2)</enum><text>preclude the group health plan or health insurance issuer involved from requiring that the obstetrical or gynecological provider notify the primary care health care professional or the plan or issuer of treatment decisions.</text></paragraph></subsection></section> <section id="H9C17AE12B53B4335BD80EF3B009DB4C0"><enum>116.</enum><header>Access to pediatric care</header> <subsection id="H830FACCF56CC4BCD9F6B71C10367C19E"><enum>(a)</enum><header>Pediatric care</header><text>In the case of a person who has a child who is a participant, beneficiary, or enrollee under a group health plan, or health insurance coverage offered by a health insurance issuer, if the plan or issuer requires or provides for the designation of a participating primary care provider for the child, the plan or issuer shall permit such person to designate a physician (allopathic or osteopathic) who specializes in pediatrics as the child’s primary care provider if such provider participates in the network of the plan or issuer.</text></subsection> <subsection id="H2519E8FFC2484A63AA14C8D00FD0433"><enum>(b)</enum><header>Construction</header><text>Nothing in subsection (a) shall be construed to waive any exclusions of coverage under the terms and conditions of the plan or health insurance coverage with respect to coverage of pediatric care.</text></subsection></section> <section id="HAF297D5C86C94704B744F92EB12DB418"><enum>117.</enum><header>Continuity of care</header> <subsection id="H9A97AAB23C1642AB87B9592E6B96737F"><enum>(a)</enum><header>Termination of provider</header> <paragraph id="H3207E03DA6B34F979CD251EBD950F13"><enum>(1)</enum><header>In general</header><text>If—</text> <subparagraph id="HB4EE1700AA3E48DA8452A4CC988B99EA"><enum>(A)</enum><text>a contract between a group health plan, or a health insurance issuer offering health insurance coverage, and a treating health care provider is terminated (as defined in paragraph (e)(4)), or</text></subparagraph> <subparagraph id="H68C7259B24614A45B2FFCDD8D1C9C205"><enum>(B)</enum><text>benefits or coverage provided by a health care provider are terminated because of a change in the terms of provider participation in such plan or coverage,</text></subparagraph><continuation-text continuation-text-level="paragraph">the plan or issuer shall meet the requirements of paragraph (3) with respect to each continuing care patient.</continuation-text></paragraph> <paragraph id="H8D5FA773131848F69051EE00F4067EC6"><enum>(2)</enum><header>Treatment of termination of contract with health insurance issuer</header><text>If a contract for the provision of health insurance coverage between a group health plan and a health insurance issuer is terminated and, as a result of such termination, coverage of services of a health care provider is terminated with respect to an individual, the provisions of paragraph (1) (and the succeeding provisions of this section) shall apply under the plan in the same manner as if there had been a contract between the plan and the provider that had been terminated, but only with respect to benefits that are covered under the plan after the contract termination.</text></paragraph> <paragraph id="H20AB5FD7A56941D5B300115E542FE150"><enum>(3)</enum><header>Requirements</header><text>The requirements of this paragraph are that the plan or issuer—</text> <subparagraph id="H0C86F9198AD84A44BCEA35E71E6B2D5E"><enum>(A)</enum><text>notify the continuing care patient involved, or arrange to have the patient notified pursuant to subsection (d)(2), on a timely basis of the termination described in paragraph (1) (or paragraph (2), if applicable) and the right to elect continued transitional care from the provider under this section;</text></subparagraph> <subparagraph id="H6870F63DCA21463E9DD93C537439669F"><enum>(B)</enum><text>provide the patient with an opportunity to notify the plan or issuer of the patient’s need for transitional care; and</text></subparagraph> <subparagraph id="H2D450D95D1FC4AFF9B807578DF5D2437"><enum>(C)</enum><text>subject to subsection (c), permit the patient to elect to continue to be covered with respect to the course of treatment by such provider with the provider’s consent during a transitional period (as provided for under subsection (b)).</text></subparagraph></paragraph> <paragraph id="H7A16D1C01FE7458FA5D0F5DEB3E192E"><enum>(4)</enum><header>Continuing care patient</header><text>For purposes of this section, the term <term>continuing care patient</term> means a participant, beneficiary, or enrollee who—</text> <subparagraph id="HF02764E743684222896B340000C7C753"><enum>(A)</enum><text>is undergoing a course of treatment for a serious and complex condition from the provider at the time the plan or issuer receives or provides notice of provider, benefit, or coverage termination described in paragraph (1) (or paragraph (2), if applicable);</text></subparagraph> <subparagraph id="H02CCD9CED78046CBBB193430BFB8CFA6"><enum>(B)</enum><text>is undergoing a course of institutional or inpatient care from the provider at the time of such notice;</text></subparagraph> <subparagraph id="HBEE245538DA349268E6FD4A23C446E19"><enum>(C)</enum><text>is scheduled to undergo non-elective surgery from the provider at the time of such notice;</text></subparagraph> <subparagraph id="HEBB8441BBE41489092D1733632F1DF2E"><enum>(D)</enum><text>is pregnant and undergoing a course of treatment for the pregnancy from the provider at the time of such notice; or</text></subparagraph> <subparagraph id="H57AFD9EE40EF4A36865F65D7E13A072"><enum>(E)</enum><text>is or was determined to be terminally ill (as determined under section 1861(dd)(3)(A) of the <act-name parsable-cite="SSA">Social Security Act</act-name>) at the time of such notice, but only with respect to a provider that was treating the terminal illness before the date of such notice.</text></subparagraph></paragraph></subsection> <subsection id="HEBB61A013972482AA8E330AC1160D1"><enum>(b)</enum><header>Transitional periods</header> <paragraph id="HA4E436EEE1244C978F6EFC9D961985AA"><enum>(1)</enum><header>Serious and complex conditions</header><text>The transitional period under this subsection with respect to a continuing care patient described in subsection (a)(4)(A) shall extend for up to 90 days (as determined by the treating health care professional) from the date of the notice described in subsection (a)(3)(A).</text></paragraph> <paragraph id="H435EF2CAEA664B16BA87B208757325F"><enum>(2)</enum><header>Institutional or inpatient care</header><text>The transitional period under this subsection for a continuing care patient described in subsection (a)(4)(B) shall extend until the earlier of—</text> <subparagraph id="H928B05426BC44A1DA168EFB86397CB00"><enum>(A)</enum><text>the expiration of the 90-day period beginning on the date on which the notice under subsection (a)(3)(A) is provided; or</text></subparagraph> <subparagraph id="HE81668E06BCC46249870FA53A9C06DB7"><enum>(B)</enum><text>the date of discharge of the patient from such care or the termination of the period of institutionalization, or, if later, the date of completion of reasonable follow-up care.</text></subparagraph></paragraph> <paragraph id="HD22A92F4330B4488A4011004F897F1B7"><enum>(3)</enum><header>Scheduled non-elective surgery</header><text>The transitional period under this subsection for a continuing care patient described in subsection (a)(4)(C) shall extend until the completion of the surgery involved and post-surgical follow-up care relating to the surgery and occurring within 90 days after the date of the surgery.</text></paragraph> <paragraph id="H9ECA559972C74E2686C13CE0D902E41C"><enum>(4)</enum><header>Pregnancy</header><text>The transitional period under this subsection for a continuing care patient described in subsection (a)(4)(D) shall extend through the provision of post-partum care directly related to the delivery.</text></paragraph> <paragraph id="HC94C97E87AA6486896D4CE4D3FD5F69F"><enum>(5)</enum><header>Terminal illness</header><text>The transitional period under this subsection for a continuing care patient described in subsection (a)(4)(E) shall extend for the remainder of the patient’s life for care that is directly related to the treatment of the terminal illness or its medical manifestations.</text></paragraph></subsection> <subsection id="HE8B33F295B1B40C6B7DA908B10CCD4CD"><enum>(c)</enum><header>Permissible terms and conditions</header><text>A group health plan or health insurance issuer may condition coverage of continued treatment by a provider under this section upon the provider agreeing to the following terms and conditions:</text> <paragraph id="HB393342004E54438A894A2DB84F3798"><enum>(1)</enum><text>The treating health care provider agrees to accept reimbursement from the plan or issuer and continuing care patient involved (with respect to cost-sharing) at the rates applicable prior to the start of the transitional period as payment in full (or, in the case described in subsection (a)(2), at the rates applicable under the replacement plan or coverage after the date of the termination of the contract with the group health plan or health insurance issuer) and not to impose cost-sharing with respect to the patient in an amount that would exceed the cost-sharing that could have been imposed if the contract referred to in subsection (a)(1) had not been terminated.</text></paragraph> <paragraph id="HCC156FACD1284BA49784A8EB005000A"><enum>(2)</enum><text>The treating health care provider agrees to adhere to the quality assurance standards of the plan or issuer responsible for payment under paragraph (1) and to provide to such plan or issuer necessary medical information related to the care provided.</text></paragraph> <paragraph id="H0CEA54F062C0475B8C82490055001891"><enum>(3)</enum><text>The treating health care provider agrees otherwise to adhere to such plan’s or issuer’s policies and procedures, including procedures regarding referrals and obtaining prior authorization and providing services pursuant to a treatment plan (if any) approved by the plan or issuer.</text></paragraph></subsection> <subsection id="HFA00A7556468435FA8FA2BBA6F32C659"><enum>(d)</enum><header>Rules of construction</header><text>Nothing in this section shall be construed—</text> <paragraph id="H64D5CB4AC05F4080B0ACD2AB92E62CE2"><enum>(1)</enum><text>to require the coverage of benefits which would not have been covered if the provider involved remained a participating provider; or</text></paragraph> <paragraph id="H3640F6867EAC4937AD581878FE71E8B7"><enum>(2)</enum><text>with respect to the termination of a contract under subsection (a) to prevent a group health plan or health insurance issuer from requiring that the health care provider—</text> <subparagraph id="HD166E3DC630E44B1B0AAA503F930F0C9"><enum>(A)</enum><text>notify participants, beneficiaries, or enrollees of their rights under this section; or</text></subparagraph> <subparagraph id="HBB41096F4DBA458482EAC7F05BA3FEE6"><enum>(B)</enum><text>provide the plan or issuer with the name of each participant, beneficiary, or enrollee who the provider believes is a continuing care patient.</text></subparagraph></paragraph></subsection> <subsection id="H81A17EEE517D490BA6A3C88D20EE15E"><enum>(e)</enum><header>Definitions</header><text>In this section:</text> <paragraph id="HA8D82CCE2A8749A8B3B25517EA44EE51"><enum>(1)</enum><header>Contract</header><text>The term <term>contract</term> includes, with respect to a plan or issuer and a treating health care provider, a contract between such plan or issuer and an organized network of providers that includes the treating health care provider, and (in the case of such a contract) the contract between the treating health care provider and the organized network.</text></paragraph> <paragraph id="H9D26770BD4904189A3CB33A52FB3C72E"><enum>(2)</enum><header>Health care provider</header><text>The term <term>health care provider</term> or <term>provider</term> means—</text> <subparagraph id="HB5154A706E4A43988F6405A784B8E861"><enum>(A)</enum><text>any individual who is engaged in the delivery of health care services in a State and who is required by State law or regulation to be licensed or certified by the State to engage in the delivery of such services in the State; and</text></subparagraph> <subparagraph id="H49163EF95D7E4EFEAF67F281F587F3FB"><enum>(B)</enum><text>any entity that is engaged in the delivery of health care services in a State and that, if it is required by State law or regulation to be licensed or certified by the State to engage in the delivery of such services in the State, is so licensed.</text></subparagraph></paragraph> <paragraph id="H2CAC033926034CFA8FCCABB3C08EDB27"><enum>(3)</enum><header>Serious and complex condition</header><text>The term <term>serious and complex condition</term> means, with respect to a participant, beneficiary, or enrollee under the plan or coverage—</text> <subparagraph id="H66D6AE8E30FC47DF89E55BE77A5889C"><enum>(A)</enum><text>in the case of an acute illness, a condition that is serious enough to require specialized medical treatment to avoid the reasonable possibility of death or permanent harm; or</text></subparagraph> <subparagraph id="HEFAEAE44EF0342A48623F48B63DD29FF"><enum>(B)</enum><text>in the case of a chronic illness or condition, is an ongoing special condition (as defined in section 114(b)(2)(B)).</text></subparagraph></paragraph> <paragraph id="HB9428ADF586B4529958555101F1BA700"><enum>(4)</enum><header>Terminated</header><text>The term <term>terminated</term> includes, with respect to a contract, the expiration or nonrenewal of the contract, but does not include a termination of the contract for failure to meet applicable quality standards or for fraud.</text></paragraph></subsection></section> <section id="H3E71E7EF7933482E8C6EBA2EDD36E5EE"><enum>118.</enum><header>Access to needed prescription drugs</header> <subsection id="H0063C1FC40DB4B10A1834F92A50266F"><enum>(a)</enum><header>In general</header><text>To the extent that a group health plan, or health insurance coverage offered by a health insurance issuer, provides coverage for benefits with respect to prescription drugs, and limits such coverage to drugs included in a formulary, the plan or issuer shall—</text> <paragraph id="H45D3E805E99443C081E944C1EB269B00"><enum>(1)</enum><text>ensure the participation of physicians and pharmacists in developing and reviewing such formulary;</text></paragraph> <paragraph id="HF0CF269F27914ACA9FC29601B8F8C7F0"><enum>(2)</enum><text>provide for disclosure of the formulary to providers; and</text></paragraph> <paragraph id="H7D9DD4CF04AC4F6C8436007BA483CE18"><enum>(3)</enum><text>in accordance with the applicable quality assurance and utilization review standards of the plan or issuer, provide for exceptions from the formulary limitation when a non-formulary alternative is medically necessary and appropriate and, in the case of such an exception, apply the same cost-sharing requirements that would have applied in the case of a drug covered under the formulary.</text></paragraph></subsection> <subsection id="H5E945A1B3E3D474FB782E5F600EAB85C"><enum>(b)</enum><header>Coverage of approved drugs and medical devices</header> <paragraph id="H91C383E47A8C4F039EFD7D00563455E9"><enum>(1)</enum><header>In general</header><text>A group health plan (and health insurance coverage offered in connection with such a plan) that provides any coverage of prescription drugs or medical devices shall not deny coverage of such a drug or device on the basis that the use is investigational, if the use—</text> <subparagraph id="HF22AFC46B5B14FB2992D39B296A63700"><enum>(A)</enum><text>in the case of a prescription drug—</text> <clause id="H79247514F8CE443EBF3E254254F188DB"><enum>(i)</enum><text>is included in the labeling authorized by the application in effect for the drug pursuant to subsection (b) or (j) of section 505 of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>, without regard to any postmarketing requirements that may apply under such Act; or</text></clause> <clause id="H82E709F42A1744F5858EAE6F2E265D14"><enum>(ii)</enum><text>is included in the labeling authorized by the application in effect for the drug under section 351 of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name>, without regard to any postmarketing requirements that may apply pursuant to such section; or</text></clause></subparagraph> <subparagraph id="H3FA0D6D700EF4BB3AAE154BA549B42F0"><enum>(B)</enum><text>in the case of a medical device, is included in the labeling authorized by a regulation under subsection (d) or (3) of section 513 of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>, an order under subsection (f) of such section, or an application approved under section 515 of such Act, without regard to any postmarketing requirements that may apply under such Act.</text></subparagraph></paragraph> <paragraph id="H3C4B8F2154C348228BEFEFA0ADC18598"><enum>(2)</enum><header>Construction</header><text>Nothing in this subsection shall be construed as requiring a group health plan (or health insurance coverage offered in connection with such a plan) to provide any coverage of prescription drugs or medical devices.</text></paragraph></subsection></section> <section id="HA1664824F5A44166B8A75782D4D3EC94"><enum>119.</enum><header>Coverage for individuals participating in approved clinical trials</header> <subsection id="HA902416FD18843FA00456311A7B4DC8"><enum>(a)</enum><header>Coverage</header> <paragraph id="H485FA3101F6746BFBBFFB8B49E30FCAB"><enum>(1)</enum><header>In general</header><text>If a group health plan, or health insurance issuer that is providing health insurance coverage, provides coverage to a qualified individual (as defined in subsection (b)), the plan or issuer—</text> <subparagraph id="H555F6EEE7A3A43EDBF26D182463F2B33"><enum>(A)</enum><text>may not deny the individual participation in the clinical trial referred to in subsection (b)(2);</text></subparagraph> <subparagraph id="H6019E67D4DDE470593BA61B1467B38C"><enum>(B)</enum><text>subject to subsection (c), may not deny (or limit or impose additional conditions on) the coverage of routine patient costs for items and services furnished in connection with participation in the trial; and</text></subparagraph> <subparagraph id="HFBBC424E24F84E31AAD376937B803D5C"><enum>(C)</enum><text>may not discriminate against the individual on the basis of the enrollee’s participation in such trial.</text></subparagraph></paragraph> <paragraph id="H4AF4B9926D964FB483D3D0DFFAB16400"><enum>(2)</enum><header>Exclusion of certain costs</header><text>For purposes of paragraph (1)(B), routine patient costs do not include the cost of the tests or measurements conducted primarily for the purpose of the clinical trial involved.</text></paragraph> <paragraph id="H677F094748FA45AF974677C92BB508CC"><enum>(3)</enum><header>Use of in-network providers</header><text>If one or more participating providers is participating in a clinical trial, nothing in paragraph (1) shall be construed as preventing a plan or issuer from requiring that a qualified individual participate in the trial through such a participating provider if the provider will accept the individual as a participant in the trial.</text></paragraph></subsection> <subsection id="H19CE081B63374214991C6FFD6C940000"><enum>(b)</enum><header>Qualified individual defined</header><text>For purposes of subsection (a), the term <term>qualified individual</term> means an individual who is a participant or beneficiary in a group health plan, or who is an enrollee under health insurance coverage, and who meets the following conditions:</text> <paragraph id="HD7E693935F9448818792B0EFC9007759"><enum>(1)</enum><text>(A) The individual has a life-threatening or serious illness for which no standard treatment is effective.</text> <subparagraph indent="up1" id="H33DCEBB4FE6A45BEA8D15BF10DFE2A1"><enum>(B)</enum><text>The individual is eligible to participate in an approved clinical trial according to the trial protocol with respect to treatment of such illness.</text></subparagraph> <subparagraph indent="up1" id="HC705CFE3D30D4252A3E0E0D284AF7CCE"><enum>(C)</enum><text>The individual’s participation in the trial offers meaningful potential for significant clinical benefit for the individual.</text></subparagraph></paragraph> <paragraph id="HF0E7BC8D60CA43B7ABBEEF050439D310"><enum>(2)</enum><text>Either—</text> <subparagraph id="H3735F2022E3746ADABE202C5396B8880"><enum>(A)</enum><text>the referring physician is a participating health care professional and has concluded that the individual’s participation in such trial would be appropriate based upon the individual meeting the conditions described in paragraph (1); or</text></subparagraph> <subparagraph id="H6635C18E12E7453A8FE218C71380C9D0"><enum>(B)</enum><text>the participant, beneficiary, or enrollee provides medical and scientific information establishing that the individual’s participation in such trial would be appropriate based upon the individual meeting the conditions described in paragraph (1).</text></subparagraph></paragraph></subsection> <subsection id="H78DA277C331E434F008967FB1152F2BF"><enum>(c)</enum><header>Payment</header> <paragraph id="HBE667DCCAC2A47919B7C3D62D1DC34B3"><enum>(1)</enum><header>In general</header><text>Under this section a group health plan and a health insurance issuer shall provide for payment for routine patient costs described in subsection (a)(2) but is not required to pay for costs of items and services that are reasonably expected (as determined by the appropriate Secretary) to be paid for by the sponsors of an approved clinical trial.</text></paragraph> <paragraph id="HDECCCF1E2D90461493194BC46632DB4E"><enum>(2)</enum><header>Payment rate</header><text>In the case of covered items and services provided by—</text> <subparagraph id="H27A41238C0FC494E98869F2F6309EFC7"><enum>(A)</enum><text>a participating provider, the payment rate shall be at the agreed upon rate; or</text></subparagraph> <subparagraph id="H800217383F59420E9F9800E230048494"><enum>(B)</enum><text>a nonparticipating provider, the payment rate shall be at the rate the plan or issuer would normally pay for comparable services under subparagraph (A).</text></subparagraph></paragraph></subsection> <subsection id="HDD9225BC924C417887B4474F48DBC9F2"><enum>(d)</enum><header>Approved clinical trial defined</header> <paragraph id="H79D5003C2F7744CD95943BBDB145A49F"><enum>(1)</enum><header>In general</header><text>In this section, the term <term>approved clinical trial</term> means a clinical research study or clinical investigation—</text> <subparagraph id="H27F47B4C44FC494BBD00129E00EAE3D"><enum>(A)</enum><text>approved and funded (which may include funding through in-kind contributions) by one or more of the following:</text> <clause id="HDD48B7B964974746B551429364E705D3"><enum>(i)</enum><text>the National Institutes of Health;</text></clause> <clause id="HDED0B0D574F24E9EA929CA0017C7D1A"><enum>(ii)</enum><text>a cooperative group or center of the National Institutes of Health, including a qualified nongovernmental research entity to which the National Cancer Institute has awarded a center support grant;</text></clause> <clause id="HE47475A9427C4CFBA0FC5251D13463B4"><enum>(iii)</enum><text>either of the following if the conditions described in paragraph (2) are met—</text> <subclause id="HF1FB289B69F84FFFA22FDF007CE166F6"><enum>(I)</enum><text>the Department of Veterans Affairs;</text></subclause> <subclause id="HBE943247427C4A29B100BE8B8FF3EE9"><enum>(II)</enum><text>the Department of Defense; or</text></subclause></clause></subparagraph> <subparagraph id="HF3D7AE9936A6464380B600F9763E58BC"><enum>(B)</enum><text>approved by the Food and Drug Administration.</text></subparagraph></paragraph> <paragraph id="HF1FBDAC30EC44880AFBDF61B7900F9F1"><enum>(2)</enum><header>Conditions for departments</header><text>The conditions described in this paragraph, for a study or investigation conducted by a Department, are that the study or investigation has been reviewed and approved through a system of peer review that the appropriate Secretary determines—</text> <subparagraph id="HFEFEFBD556D642B18509166D03595C43"><enum>(A)</enum><text>to be comparable to the system of peer review of studies and investigations used by the National Institutes of Health; and</text></subparagraph> <subparagraph id="HE850940168EE4EB2870067B2FC1ECA14"><enum>(B)</enum><text>assures unbiased review of the highest ethical standards by qualified individuals who have no interest in the outcome of the review.</text></subparagraph></paragraph></subsection> <subsection id="H5DFB2B3470F947CFAC5248C9D6CD488"><enum>(e)</enum><header>Construction</header><text>Nothing in this section shall be construed to limit a plan’s or issuer’s coverage with respect to clinical trials.</text></subsection></section> <section id="H3860BE55EA4C4427B4423E6C28793188"><enum>120.</enum><header>Required coverage for minimum hospital stay for mastectomies and lymph node dissections for the treatment of breast cancer and coverage for secondary consultations</header> <subsection id="H99084396297141BE00EAF007C50161D8"><enum>(a)</enum><header>Inpatient care</header> <paragraph id="H3F7B7A8AEC6644CD982347CBAE3783F9"><enum>(1)</enum><header>In general</header><text>A group health plan, and a health insurance issuer providing health insurance coverage, that provides medical and surgical benefits shall ensure that inpatient coverage with respect to the treatment of breast cancer is provided for a period of time as is determined by the attending physician, in consultation with the patient, to be medically necessary and appropriate following—</text> <subparagraph id="H7E80297F4DC348ACBA6CACA362086BA"><enum>(A)</enum><text>a mastectomy;</text></subparagraph> <subparagraph id="H2A77133F412346F48717AFDFB5CD790"><enum>(B)</enum><text>a lumpectomy; or</text></subparagraph> <subparagraph id="H6B529E133A3141CE9892E5CF9FDB2C57"><enum>(C)</enum><text>a lymph node dissection for the treatment of breast cancer.</text></subparagraph></paragraph> <paragraph id="HCAFBFD91574F4C74A56059C719C37136"><enum>(2)</enum><header>Exception</header><text>Nothing in this section shall be construed as requiring the provision of inpatient coverage if the attending physician and patient determine that a shorter period of hospital stay is medically appropriate.</text></paragraph></subsection> <subsection id="H06B7B6F28A1F4095BC2F111EE1122F81"><enum>(b)</enum><header>Prohibition on certain modifications</header><text>In implementing the requirements of this section, a group health plan, and a health insurance issuer providing health insurance coverage, may not modify the terms and conditions of coverage based on the determination by a participant, beneficiary, or enrollee to request less than the minimum coverage required under subsection (a).</text></subsection> <subsection id="HD875D11E8A3D40A38740D7B462FB0E5"><enum>(c)</enum><header>Secondary consultations</header> <paragraph id="H8EE88A46BC1E4C92B0B431B402271C69"><enum>(1)</enum><header>In general</header><text>A group health plan, and a health insurance issuer providing health insurance coverage, that provides coverage with respect to medical and surgical services provided in relation to the diagnosis and treatment of cancer shall ensure that full coverage is provided for secondary consultations by specialists in the appropriate medical fields (including pathology, radiology, and oncology) to confirm or refute such diagnosis. Such plan or issuer shall ensure that full coverage is provided for such secondary consultation whether such consultation is based on a positive or negative initial diagnosis. In any case in which the attending physician certifies in writing that services necessary for such a secondary consultation are not sufficiently available from specialists operating under the plan or coverage with respect to whose services coverage is otherwise provided under such plan or by such issuer, such plan or issuer shall ensure that coverage is provided with respect to the services necessary for the secondary consultation with any other specialist selected by the attending physician for such purpose at no additional cost to the individual beyond that which the individual would have paid if the specialist was participating in the network of the plan or issuer.</text></paragraph> <paragraph id="H497C1259CA524DF6A75B4564EDDED5E9"><enum>(2)</enum><header>Exception</header><text>Nothing in paragraph (1) shall be construed as requiring the provision of secondary consultations where the patient determines not to seek such a consultation.</text></paragraph></subsection> <subsection id="HA5BCC60C7CE44FE2AEC567C0375383AC"><enum>(d)</enum><header>Prohibition on penalties or incentives</header><text>A group health plan, and a health insurance issuer providing health insurance coverage, may not—</text> <paragraph id="HB7332D24E9074659B87036C62D2BFA70"><enum>(1)</enum><text>penalize or otherwise reduce or limit the reimbursement of a provider or specialist because the provider or specialist provided care to a participant, beneficiary, or enrollee in accordance with this section;</text></paragraph> <paragraph id="H7C06EB5BFE2A443398F9D8EE9808B5C7"><enum>(2)</enum><text>provide financial or other incentives to a physician or specialist to induce the physician or specialist to keep the length of inpatient stays of patients following a mastectomy, lumpectomy, or a lymph node dissection for the treatment of breast cancer below certain limits or to limit referrals for secondary consultations; or</text></paragraph> <paragraph id="H1904A310D8B3428CB74F465DEB49CCAC"><enum>(3)</enum><text>provide financial or other incentives to a physician or specialist to induce the physician or specialist to refrain from referring a participant, beneficiary, or enrollee for a secondary consultation that would otherwise be covered by the plan or coverage involved under subsection (c).</text></paragraph></subsection></section></subtitle> <subtitle id="H6AEAD63EA5EC4120AFBD3868A2C8B3CD"><enum>C</enum><header>Access to information</header> <section id="HA3ABE6BAD92545E100FEB562CE303DC"><enum>121.</enum><header>Patient access to information</header> <subsection id="HF3E42A08B09C4F78B957A2C28E871229"><enum>(a)</enum><header>Requirement</header> <paragraph id="H2339FFB0967D4337B6FFAD6D3E5445EC"><enum>(1)</enum><header>Disclosure</header> <subparagraph id="H641DF7E6E9EB407C96106534CA1B7391"><enum>(A)</enum><header>In general</header><text>A group health plan, and a health insurance issuer that provides coverage in connection with health insurance coverage, shall provide for the disclosure to participants, beneficiaries, and enrollees—</text> <clause id="HFA9D5171344F4D1C00A520B43BC5E306"><enum>(i)</enum><text>of the information described in subsection (b) at the time of the initial enrollment of the participant, beneficiary, or enrollee under the plan or coverage;</text></clause> <clause id="HCB1DE3CA3ECD44F8B959223E0045BAE2"><enum>(ii)</enum><text>of such information on an annual basis—</text> <subclause id="HB3D211CE68B34800BCC5DCF614DC1CD"><enum>(I)</enum><text>in conjunction with the election period of the plan or coverage if the plan or coverage has such an election period; or</text></subclause> <subclause id="H20C0CE8123FF41A6BD8D19DC712EA865"><enum>(II)</enum><text>in the case of a plan or coverage that does not have an election period, in conjunction with the beginning of the plan or coverage year; and</text></subclause></clause> <clause id="H36970CE08B6240D3933075659D8BB9F3"><enum>(iii)</enum><text>of information relating to any material reduction to the benefits or information described in such subsection or subsection (c), in the form of a notice provided not later than 30 days before the date on which the reduction takes effect.</text></clause></subparagraph> <subparagraph id="HDB62C2BEA5594870A6B9628347F619FF"><enum>(B)</enum><header>Participants, beneficiaries, and enrollees</header><text>The disclosure required under subparagraph (A) shall be provided—</text> <clause id="HAE9CC86F5A3540B68C08EFD4EBD88C22"><enum>(i)</enum><text>jointly to each participant, beneficiary, and enrollee who reside at the same address; or</text></clause> <clause id="HECE5DC1F233C4A238010BB6386057E48"><enum>(ii)</enum><text>in the case of a beneficiary or enrollee who does not reside at the same address as the participant or another enrollee, separately to the participant or other enrollees and such beneficiary or enrollee.</text></clause></subparagraph></paragraph> <paragraph id="H4CF829C6C7CF4D890045B1726F6290BA"><enum>(2)</enum><header>Provision of information</header><text>Information shall be provided to participants, beneficiaries, and enrollees under this section at the last known address maintained by the plan or issuer with respect to such participants, beneficiaries, or enrollees, to the extent that such information is provided to participants, beneficiaries, or enrollees via the United States Postal Service or other private delivery service.</text></paragraph></subsection> <subsection id="H15FBEE1855BA471AA8377894669343D2"><enum>(b)</enum><header>Required information</header><text>The informational materials to be distributed under this section shall include for each option available under the group health plan or health insurance coverage the following:</text> <paragraph id="HF6576FC98FC74781915D896B4387A3E6"><enum>(1)</enum><header>Benefits</header><text>A description of the covered benefits, including—</text> <subparagraph id="HAE56B95D42B74298A26C7D74DC34E54B"><enum>(A)</enum><text>any in- and out-of-network benefits;</text></subparagraph> <subparagraph id="H405C1256D75342789E00F7AFC71699BC"><enum>(B)</enum><text>specific preventive services covered under the plan or coverage if such services are covered;</text></subparagraph> <subparagraph id="H786581B0C1554D03BA6D94FF488E90C3"><enum>(C)</enum><text>any specific exclusions or express limitations of benefits described in section 104(d)(3)(C);</text></subparagraph> <subparagraph id="H77F8355CE95246F39C55F5AC71F1DA5"><enum>(D)</enum><text>any other benefit limitations, including any annual or lifetime benefit limits and any monetary limits or limits on the number of visits, days, or services, and any specific coverage exclusions; and</text></subparagraph> <subparagraph id="H6DA9F5B9D6354B39BE25A3072F8BB01"><enum>(E)</enum><text>any definition of medical necessity used in making coverage determinations by the plan, issuer, or claims administrator.</text></subparagraph></paragraph> <paragraph id="HE4DEA5C87D964899BC50DCAB55226948"><enum>(2)</enum><header>Cost sharing</header><text>A description of any cost-sharing requirements, including—</text> <subparagraph id="H203CBE8E396E4AFF885763005E2CFBD5"><enum>(A)</enum><text>any premiums, deductibles, coinsurance, copayment amounts, and liability for balance billing, for which the participant, beneficiary, or enrollee will be responsible under each option available under the plan;</text></subparagraph> <subparagraph id="HE76FC854FF6B44878F00006ED9E1A19E"><enum>(B)</enum><text>any maximum out-of-pocket expense for which the participant, beneficiary, or enrollee may be liable;</text></subparagraph> <subparagraph id="H3ACBCA7F086B44429D468659BEA3BBFC"><enum>(C)</enum><text>any cost-sharing requirements for out-of-network benefits or services received from nonparticipating providers; and</text></subparagraph> <subparagraph id="H806514229C194603BCD456F200008997"><enum>(D)</enum><text>any additional cost-sharing or charges for benefits and services that are furnished without meeting applicable plan or coverage requirements, such as prior authorization or precertification.</text></subparagraph></paragraph> <paragraph id="HDD0669CE80EC4FE5823818EFF2ABFD40"><enum>(3)</enum><header>Disenrollment</header><text>Information relating to the disenrollment of a participant, beneficiary, or enrollee.</text></paragraph> <paragraph id="H13B30739F62C4FC7B25CFD63D87779DA"><enum>(4)</enum><header>Service area</header><text>A description of the plan or issuer’s service area, including the provision of any out-of-area coverage.</text></paragraph> <paragraph id="HA5F222BB0D454E3784724D9C226683DF"><enum>(5)</enum><header>Participating providers</header><text>A directory of participating providers (to the extent a plan or issuer provides coverage through a network of providers) that includes, at a minimum, the name, address, and telephone number of each participating provider, and information about how to inquire whether a participating provider is currently accepting new patients.</text></paragraph> <paragraph id="HA0298ACC28F24FFEB0D5DA4845D6C025"><enum>(6)</enum><header>Choice of primary care provider</header><text>A description of any requirements and procedures to be used by participants, beneficiaries, and enrollees in selecting, accessing, or changing their primary care provider, including providers both within and outside of the network (if the plan or issuer permits out-of-network services), and the right to select a pediatrician as a primary care provider under section 116 for a participant, beneficiary, or enrollee who is a child if such section applies.</text></paragraph> <paragraph id="HAF3B633BDCAE42CCA8CDDB3C08E11800"><enum>(7)</enum><header>Preauthorization requirements</header><text>A description of the requirements and procedures to be used to obtain preauthorization for health services, if such preauthorization is required.</text></paragraph> <paragraph id="H4706F77F56754B6B9542109EF956D6BC"><enum>(8)</enum><header>Experimental and investigational treatments</header><text>A description of the process for determining whether a particular item, service, or treatment is considered experimental or investigational, and the circumstances under which such treatments are covered by the plan or issuer.</text></paragraph> <paragraph id="HA220E47A9855424F0000FFEBCD5FBCFC"><enum>(9)</enum><header>Specialty care</header><text>A description of the requirements and procedures to be used by participants, beneficiaries, and enrollees in accessing specialty care and obtaining referrals to participating and nonparticipating specialists, including any limitations on choice of health care professionals referred to in section 112(b)(2) and the right to timely access to specialists care under section 114 if such section applies.</text></paragraph> <paragraph id="H9CD07CB1A9B244DDBEDB7E2000478715"><enum>(10)</enum><header>Clinical trials</header><text>A description of the circumstances and conditions under which participation in clinical trials is covered under the terms and conditions of the plan or coverage, and the right to obtain coverage for approved clinical trials under section 119 if such section applies.</text></paragraph> <paragraph id="HD8B7AA8C3D934AB3A5166661EA789B96"><enum>(11)</enum><header>Prescription drugs</header><text>To the extent the plan or issuer provides coverage for prescription drugs, a statement of whether such coverage is limited to drugs included in a formulary, a description of any provisions and cost-sharing required for obtaining on- and off-formulary medications, and a description of the rights of participants, beneficiaries, and enrollees in obtaining access to access to prescription drugs under section 118 if such section applies.</text></paragraph> <paragraph id="H498D4653E512455FA16BD2AC105C5C58"><enum>(12)</enum><header>Emergency services</header><text>A summary of the rules and procedures for accessing emergency services, including the right of a participant, beneficiary, or enrollee to obtain emergency services under the prudent layperson standard under section 113, if such section applies, and any educational information that the plan or issuer may provide regarding the appropriate use of emergency services.</text></paragraph> <paragraph id="H9C59E1D7AB814695AF2BDC9DE25F75"><enum>(13)</enum><header>Claims and appeals</header><text>A description of the plan or issuer’s rules and procedures pertaining to claims and appeals, a description of the rights (including deadlines for exercising rights) of participants, beneficiaries, and enrollees under subtitle A in obtaining covered benefits, filing a claim for benefits, and appealing coverage decisions internally and externally (including telephone numbers and mailing addresses of the appropriate authority), and a description of any additional legal rights and remedies available under section 502 of the <act-name parsable-cite="ERISA">Employee Retirement Income Security Act of 1974</act-name> and applicable State law.</text></paragraph> <paragraph id="H6D4B66F967E942A2834DCC6BD1DE9F"><enum>(14)</enum><header>Advance directives and organ donation</header><text>A description of procedures for advance directives and organ donation decisions if the plan or issuer maintains such procedures.</text></paragraph> <paragraph id="H6417E935A0F740E1B37C5900E3009707"><enum>(15)</enum><header>Information on plans and issuers</header><text>The name, mailing address, and telephone number or numbers of the plan administrator and the issuer to be used by participants, beneficiaries, and enrollees seeking information about plan or coverage benefits and services, payment of a claim, or authorization for services and treatment. Notice of whether the benefits under the plan or coverage are provided under a contract or policy of insurance issued by an issuer, or whether benefits are provided directly by the plan sponsor who bears the insurance risk.</text></paragraph> <paragraph id="HF86DBF19805C434A9539B51DC1654B50"><enum>(16)</enum><header>Translation services</header><text>A summary description of any translation or interpretation services (including the availability of printed information in languages other than English, audio tapes, or information in Braille) that are available for non-English speakers and participants, beneficiaries, and enrollees with communication disabilities and a description of how to access these items or services.</text></paragraph> <paragraph id="HAE9FA00C0A7F49D7A6959D7E2C037178"><enum>(17)</enum><header>Accreditation information</header><text>Any information that is made public by accrediting organizations in the process of accreditation if the plan or issuer is accredited, or any additional quality indicators (such as the results of enrollee satisfaction surveys) that the plan or issuer makes public or makes available to participants, beneficiaries, and enrollees.</text></paragraph> <paragraph id="HF35D2C84BBAF4DC385E2CE9047AC766D"><enum>(18)</enum><header>Notice of requirements</header><text>A description of any rights of participants, beneficiaries, and enrollees that are established by the <short-title>Patients’ Bill of Rights Act of 2005</short-title> (excluding those described in paragraphs (1) through (17)) if such sections apply. The description required under this paragraph may be combined with the notices of the type described in sections 711(d), 713(b), or 606(a)(1) of the <act-name parsable-cite="ERISA">Employee Retirement Income Security Act of 1974</act-name> and with any other notice provision that the appropriate Secretary determines may be combined, so long as such combination does not result in any reduction in the information that would otherwise be provided to the recipient.</text></paragraph> <paragraph id="HC1A89B05CF474012A2A5D6CF3EF92803"><enum>(19)</enum><header>Availability of additional information</header><text>A statement that the information described in subsection (c), and instructions on obtaining such information (including telephone numbers and, if available, Internet websites), shall be made available upon request.</text></paragraph> <paragraph id="H1B8A21A3270543E5A88D196D91D3FE96"><enum>(20)</enum><header>Designated decisionmakers</header><text>A description of the participants and beneficiaries with respect to whom each designated decisionmaker under the plan has assumed liability under section 502(o) of the <act-name parsable-cite="ERISA">Employee Retirement Income Security Act of 1974</act-name> and the name and address of each such decisionmaker.</text></paragraph></subsection> <subsection id="HA92402889DF64EB6BCC4CC89C4BF7400"><enum>(c)</enum><header>Additional information</header><text>The informational materials to be provided upon the request of a participant, beneficiary, or enrollee shall include for each option available under a group health plan or health insurance coverage the following:</text> <paragraph id="H382E491283C843FD88270061F13BA6F"><enum>(1)</enum><header>Status of providers</header><text>The State licensure status of the plan or issuer’s participating health care professionals and participating health care facilities, and, if available, the education, training, specialty qualifications or certifications of such professionals.</text></paragraph> <paragraph id="HFD984CF02F544BD3ACD400902387B1B9"><enum>(2)</enum><header>Compensation methods</header><text>A summary description by category of the applicable methods (such as capitation, fee-for-service, salary, bundled payments, per diem, or a combination thereof) used for compensating prospective or treating health care professionals (including primary care providers and specialists) and facilities in connection with the provision of health care under the plan or coverage.</text></paragraph> <paragraph id="H05F822C2D9764426A4237FB5A668DEA9"><enum>(3)</enum><header>Prescription drugs</header><text>Information about whether a specific prescription medication is included in the formulary of the plan or issuer, if the plan or issuer uses a defined formulary.</text></paragraph> <paragraph id="H6F472581623F4CF8B4D5874AA13B58B"><enum>(4)</enum><header>Utilization review activities</header><text>A description of procedures used and requirements (including circumstances, timeframes, and appeals rights) under any utilization review program under sections 101 and 102, including any drug formulary program under section 118.</text></paragraph> <paragraph id="H13471C3AC45B4E14A4AC03B975B8844"><enum>(5)</enum><header>External appeals information</header><text>Aggregate information on the number and outcomes of external medical reviews, relative to the sample size (such as the number of covered lives) under the plan or under the coverage of the issuer.</text></paragraph></subsection> <subsection id="HE25D9ACAB3CC4612B64BD7004CECF040"><enum>(d)</enum><header>Manner of disclosure</header><text>The information described in this section shall be disclosed in an accessible medium and format that is calculated to be understood by a participant or enrollee.</text></subsection> <subsection id="HD580082538DC463A84BB25003994AEBD"><enum>(e)</enum><header>Rules of construction</header><text>Nothing in this section shall be construed to prohibit a group health plan, or a health insurance issuer in connection with health insurance coverage, from—</text> <paragraph id="HDAEF49EAD33B4A57B32BDBF08E74CA77"><enum>(1)</enum><text>distributing any other additional information determined by the plan or issuer to be important or necessary in assisting participants, beneficiaries, and enrollees in the selection of a health plan or health insurance coverage; and</text></paragraph> <paragraph id="H70BBC99F43B247DB873E4596B5004272"><enum>(2)</enum><text>complying with the provisions of this section by providing information in brochures, through the Internet or other electronic media, or through other similar means, so long as—</text> <subparagraph id="H27A8D5285AA3441D93DEEE5E64CF41D2"><enum>(A)</enum><text>the disclosure of such information in such form is in accordance with requirements as the appropriate Secretary may impose, and</text></subparagraph> <subparagraph id="HC388099F6C6D4DCD9910B77685DCB4E4"><enum>(B)</enum><text>in connection with any such disclosure of information through the Internet or other electronic media—</text> <clause id="HD3A5C28853B74556A4025661E4663B01"><enum>(i)</enum><text>the recipient has affirmatively consented to the disclosure of such information in such form,</text></clause> <clause id="H85530E7B95EF4250A46917E0C5C19DB"><enum>(ii)</enum><text>the recipient is capable of accessing the information so disclosed on the recipient’s individual workstation or at the recipient’s home,</text></clause> <clause id="H50473FB8400149979B79E9E7F31DAED5"><enum>(iii)</enum><text>the recipient retains an ongoing right to receive paper disclosure of such information and receives, in advance of any attempt at disclosure of such information to him or her through the Internet or other electronic media, notice in printed form of such ongoing right and of the proper software required to view information so disclosed, and</text></clause> <clause id="H836D7A9BB6894041866861AC674BD773"><enum>(iv)</enum><text>the plan administrator appropriately ensures that the intended recipient is receiving the information so disclosed and provides the information in printed form if the information is not received.</text></clause></subparagraph></paragraph></subsection></section></subtitle> <subtitle id="H4A19C31E389A408F927B4398EA61DA98"><enum>D</enum><header>Protecting the doctor-patient relationship</header> <section id="H0CE83556498442FC8DD8ED099F53C92"><enum>131.</enum><header>Prohibition of interference with certain medical communications</header> <subsection id="H137D997324C14BC900B21B46135DE9A0"><enum>(a)</enum><header>General rule</header><text>The provisions of any contract or agreement, or the operation of any contract or agreement, between a group health plan or health insurance issuer in relation to health insurance coverage (including any partnership, association, or other organization that enters into or administers such a contract or agreement) and a health care provider (or group of health care providers) shall not prohibit or otherwise restrict a health care professional from advising such a participant, beneficiary, or enrollee who is a patient of the professional about the health status of the individual or medical care or treatment for the individual’s condition or disease, regardless of whether benefits for such care or treatment are provided under the plan or coverage, if the professional is acting within the lawful scope of practice.</text></subsection> <subsection id="H2DC1FC076774455B8E95438CB987683B"><enum>(b)</enum><header>Nullification</header><text>Any contract provision or agreement that restricts or prohibits medical communications in violation of subsection (a) shall be null and void.</text></subsection></section> <section id="H9C68C3E0B4C9469ABA004B549306FB38"><enum>132.</enum><header>Prohibition of discrimination against providers based on licensure</header> <subsection id="H999DDB09063F4D89ACE28B6998C02712"><enum>(a)</enum><header>In general</header><text>A group health plan, and a health insurance issuer with respect to health insurance coverage, shall not discriminate with respect to participation or indemnification as to any provider who is acting within the scope of the provider’s license or certification under applicable State law, solely on the basis of such license or certification.</text></subsection> <subsection id="H86414BBAB43D482EAA4215E5D19BDDE6"><enum>(b)</enum><header>Construction</header><text>Subsection (a) shall not be construed—</text> <paragraph id="H0DEA27FD7AA14BA3A140BD5567000012"><enum>(1)</enum><text>as requiring the coverage under a group health plan or health insurance coverage of a particular benefit or service or to prohibit a plan or issuer from including providers only to the extent necessary to meet the needs of the plan’s or issuer’s participants, beneficiaries, or enrollees or from establishing any measure designed to maintain quality and control costs consistent with the responsibilities of the plan or issuer;</text></paragraph> <paragraph id="HD984963D4C114B28902188F68C1005C"><enum>(2)</enum><text>to override any State licensure or scope-of-practice law; or</text></paragraph> <paragraph id="H487C8E50C21245D1A38DDF00BD23771B"><enum>(3)</enum><text>as requiring a plan or issuer that offers network coverage to include for participation every willing provider who meets the terms and conditions of the plan or issuer.</text></paragraph></subsection></section> <section id="H1101EB1E76604DAF9B48D4C51EDB3494"><enum>133.</enum><header>Prohibition against improper incentive arrangements</header> <subsection id="H2598E04B3719449FAC9119A15F2DB8E1"><enum>(a)</enum><header>In general</header><text>A group health plan and a health insurance issuer offering health insurance coverage may not operate any physician incentive plan (as defined in subparagraph (B) of section 1852(j)(4) of the <act-name parsable-cite="SSA">Social Security Act</act-name>) unless the requirements described in clauses (i), (ii)(I), and (iii) of subparagraph (A) of such section are met with respect to such a plan.</text></subsection> <subsection id="H6A43CF18ED71409F9C04A670C0397D9B"><enum>(b)</enum><header>Application</header><text>For purposes of carrying out paragraph (1), any reference in section 1852(j)(4) of the <act-name parsable-cite="SSA">Social Security Act</act-name> to the Secretary, a MedicareAdvantage organization, or an individual enrolled with the organization shall be treated as a reference to the applicable authority, a group health plan or health insurance issuer, respectively, and a participant, beneficiary, or enrollee with the plan or organization, respectively.</text></subsection> <subsection id="HE2402D9C02EF4A0686F945455420C03C"><enum>(c)</enum><header>Construction</header><text>Nothing in this section shall be construed as prohibiting all capitation and similar arrangements or all provider discount arrangements.</text></subsection></section> <section id="H6549AB19215E47D3005FFEB7A2ACA8CB"><enum>134.</enum><header>Payment of claims</header><text display-inline="no-display-inline">A group health plan, and a health insurance issuer offering health insurance coverage, shall provide for prompt payment of claims submitted for health care services or supplies furnished to a participant, beneficiary, or enrollee with respect to benefits covered by the plan or issuer, in a manner that is no less protective than the provisions of section 1842(c)(2) of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395u">42 U.S.C. 1395u(c)(2)</external-xref>).</text></section> <section id="H5606E6FD6F2D415289E613B483473743"><enum>135.</enum><header>Protection for patient advocacy</header> <subsection id="H12C5573DD0D54F8C94DEC4D1A45596B7"><enum>(a)</enum><header>Protection for use of utilization review and grievance process</header><text>A group health plan, and a health insurance issuer with respect to the provision of health insurance coverage, may not retaliate against a participant, beneficiary, enrollee, or health care provider based on the participant’s, beneficiary’s, enrollee’s or provider’s use of, or participation in, a utilization review process or a grievance process of the plan or issuer (including an internal or external review or appeal process) under this title.</text></subsection> <subsection id="H25828B28347C4FA394CB29DB3FB29437"><enum>(b)</enum><header>Protection for quality advocacy by health care professionals</header> <paragraph id="H8684C94D0CE84BDAB69862145E46F96D"><enum>(1)</enum><header>In general</header><text>A group health plan and a health insurance issuer may not retaliate or discriminate against a protected health care professional because the professional in good faith—</text> <subparagraph id="H592D7AF821AF4576987FB63FD7EA41F"><enum>(A)</enum><text>discloses information relating to the care, services, or conditions affecting one or more participants, beneficiaries, or enrollees of the plan or issuer to an appropriate public regulatory agency, an appropriate private accreditation body, or appropriate management personnel of the plan or issuer; or</text></subparagraph> <subparagraph id="H7431E44137C44B03846DDEB300ED159C"><enum>(B)</enum><text>initiates, cooperates, or otherwise participates in an investigation or proceeding by such an agency with respect to such care, services, or conditions.</text></subparagraph><continuation-text continuation-text-level="paragraph">If an institutional health care provider is a participating provider with such a plan or issuer or otherwise receives payments for benefits provided by such a plan or issuer, the provisions of the previous sentence shall apply to the provider in relation to care, services, or conditions affecting one or more patients within an institutional health care provider in the same manner as they apply to the plan or issuer in relation to care, services, or conditions provided to one or more participants, beneficiaries, or enrollees; and for purposes of applying this sentence, any reference to a plan or issuer is deemed a reference to the institutional health care provider.</continuation-text></paragraph> <paragraph id="HE80FE101F4F746C3A9741409B5B6BFFD"><enum>(2)</enum><header>Good faith action</header><text>For purposes of paragraph (1), a protected health care professional is considered to be acting in good faith with respect to disclosure of information or participation if, with respect to the information disclosed as part of the action—</text> <subparagraph id="H76F1AECF9AD542B7BB00BCEED4B89437"><enum>(A)</enum><text>the disclosure is made on the basis of personal knowledge and is consistent with that degree of learning and skill ordinarily possessed by health care professionals with the same licensure or certification and the same experience;</text></subparagraph> <subparagraph id="H6829F1E4068C42CBB4C8C4DA3C4D005B"><enum>(B)</enum><text>the professional reasonably believes the information to be true;</text></subparagraph> <subparagraph id="HFB552C66E4C44CEF8596B94BB759C27"><enum>(C)</enum><text>the information evidences either a violation of a law, rule, or regulation, of an applicable accreditation standard, or of a generally recognized professional or clinical standard or that a patient is in imminent hazard of loss of life or serious injury; and</text></subparagraph> <subparagraph id="H5C58394440CC417CB3191461C3B7D5D5"><enum>(D)</enum><text>subject to subparagraphs (B) and (C) of paragraph (3), the professional has followed reasonable internal procedures of the plan, issuer, or institutional health care provider established for the purpose of addressing quality concerns before making the disclosure.</text></subparagraph></paragraph> <paragraph id="H43A7DD0199DA4EDFB5E38B9B8F2D7BBC"><enum>(3)</enum><header>Exception and special rule</header> <subparagraph id="HB87EC6AB9B924D5BBDB8E8E10028B2EB"><enum>(A)</enum><header>General exception</header><text>Paragraph (1) does not protect disclosures that would violate Federal or State law or diminish or impair the rights of any person to the continued protection of confidentiality of communications provided by such law.</text></subparagraph> <subparagraph id="H14FA0E18117F4B0295D101E3EB6250D3"><enum>(B)</enum><header>Notice of internal procedures</header><text>Subparagraph (D) of paragraph (2) shall not apply unless the internal procedures involved are reasonably expected to be known to the health care professional involved. For purposes of this subparagraph, a health care professional is reasonably expected to know of internal procedures if those procedures have been made available to the professional through distribution or posting.</text></subparagraph> <subparagraph id="H1BD04B76383643DDB2075B6E242E1BF3"><enum>(C)</enum><header>Internal procedure exception</header><text>Subparagraph (D) of paragraph (2) also shall not apply if—</text> <clause id="H02DEB94F621E42DA003407EC2885634B"><enum>(i)</enum><text>the disclosure relates to an imminent hazard of loss of life or serious injury to a patient;</text></clause> <clause id="H01CF2E557E1D4B948E33F65DDC2F7492"><enum>(ii)</enum><text>the disclosure is made to an appropriate private accreditation body pursuant to disclosure procedures established by the body; or</text></clause> <clause id="H00F038E099884E36849B85B5C9B0030"><enum>(iii)</enum><text>the disclosure is in response to an inquiry made in an investigation or proceeding of an appropriate public regulatory agency and the information disclosed is limited to the scope of the investigation or proceeding.</text></clause></subparagraph></paragraph> <paragraph id="H498B4093FF5546D2BB8DDCC045A1D200"><enum>(4)</enum><header>Additional considerations</header><text>It shall not be a violation of paragraph (1) to take an adverse action against a protected health care professional if the plan, issuer, or provider taking the adverse action involved demonstrates that it would have taken the same adverse action even in the absence of the activities protected under such paragraph.</text></paragraph> <paragraph id="HB9FEBE77D85D44288240F88C6BF864"><enum>(5)</enum><header>Notice</header><text>A group health plan, health insurance issuer, and institutional health care provider shall post a notice, to be provided or approved by the Secretary of Labor, setting forth excerpts from, or summaries of, the pertinent provisions of this subsection and information pertaining to enforcement of such provisions.</text></paragraph> <paragraph id="H6ADAB64630E444E695158737DB34F400"><enum>(6)</enum><header>Constructions</header> <subparagraph id="HED67E3BFD8284C3A82CF5B88B8722BAA"><enum>(A)</enum><header>Determinations of coverage</header><text>Nothing in this subsection shall be construed to prohibit a plan or issuer from making a determination not to pay for a particular medical treatment or service or the services of a type of health care professional.</text></subparagraph> <subparagraph id="H45285CC5A5754123A4823EA4E7004639"><enum>(B)</enum><header>Enforcement of peer review protocols and internal procedures</header><text>Nothing in this subsection shall be construed to prohibit a plan, issuer, or provider from establishing and enforcing reasonable peer review or utilization review protocols or determining whether a protected health care professional has complied with those protocols or from establishing and enforcing internal procedures for the purpose of addressing quality concerns.</text></subparagraph> <subparagraph id="H6AAD344AA21A45CC00DC6441B2E7002E"><enum>(C)</enum><header>Relation to other rights</header><text>Nothing in this subsection shall be construed to abridge rights of participants, beneficiaries, enrollees, and protected health care professionals under other applicable Federal or State laws.</text></subparagraph></paragraph> <paragraph id="H04FB4D4F276F49A892F32E4CC963DA75"><enum>(7)</enum><header>Protected health care professional defined</header><text>For purposes of this subsection, the term <term>protected health care professional</term> means an individual who is a licensed or certified health care professional and who—</text> <subparagraph id="H0112732798464E77AF4D3B173BDA8040"><enum>(A)</enum><text>with respect to a group health plan or health insurance issuer, is an employee of the plan or issuer or has a contract with the plan or issuer for provision of services for which benefits are available under the plan or issuer; or</text></subparagraph> <subparagraph id="H1194E21BF06A45E8B467A8556FA628B0"><enum>(B)</enum><text>with respect to an institutional health care provider, is an employee of the provider or has a contract or other arrangement with the provider respecting the provision of health care services.</text></subparagraph></paragraph></subsection></section></subtitle> <subtitle id="HFCF76C46461A42D285BB87D54E6C6F97"><enum>E</enum><header>Definitions</header> <section id="HE38C2B178C8E4D88875556D4CBC58780"><enum>151.</enum><header>Definitions</header> <subsection id="H6289B758B540404CAF233BB4AD2B2753"><enum>(a)</enum><header>Incorporation of general definitions</header><text>Except as otherwise provided, the provisions of section 2791 of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name> shall apply for purposes of this title in the same manner as they apply for purposes of title XXVII of such Act.</text></subsection> <subsection id="HA7606EBA9093492FB1E848C5C1832FF5"><enum>(b)</enum><header>Secretary</header><text>Except as otherwise provided, the term <term>Secretary</term> means the Secretary of Health and Human Services, in consultation with the Secretary of Labor and the term <term>appropriate Secretary</term> means the Secretary of Health and Human Services in relation to carrying out this title under sections 2706 and 2751 of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name> and the Secretary of Labor in relation to carrying out this title under section 714 of the <act-name parsable-cite="ERISA">Employee Retirement Income Security Act of 1974</act-name>.</text></subsection> <subsection id="H5872AC93828E488498C9A1681DD2A900"><enum>(c)</enum><header>Additional definitions</header><text>For purposes of this title:</text> <paragraph id="HE44AE13B1F5345CCB29600502F1971C4"><enum>(1)</enum><header>Applicable authority</header><text>The term <term>applicable authority</term> means—</text> <subparagraph id="H26B2B46C98294950AE1880DB3CCC282"><enum>(A)</enum><text>in the case of a group health plan, the Secretary of Health and Human Services and the Secretary of Labor; and</text></subparagraph> <subparagraph id="H28D8F7DCCFC648A7AFC9FD643123F981"><enum>(B)</enum><text>in the case of a health insurance issuer with respect to a specific provision of this title, the applicable State authority (as defined in section 2791(d) of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name>), or the Secretary of Health and Human Services, if such Secretary is enforcing such provision under section 2722(a)(2) or 2761(a)(2) of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name>.</text></subparagraph></paragraph> <paragraph id="HF38483E9308548409BA4AA222178604F"><enum>(2)</enum><header>Enrollee</header><text>The term <term>enrollee</term> means, with respect to health insurance coverage offered by a health insurance issuer, an individual enrolled with the issuer to receive such coverage.</text></paragraph> <paragraph id="HF6E304A332EC48F293F1602DB3B29B13"><enum>(3)</enum><header>Group health plan</header><text>The term <term>group health plan</term> has the meaning given such term in section 733(a) of the <act-name parsable-cite="ERISA">Employee Retirement Income Security Act of 1974</act-name>, except that such term includes a employee welfare benefit plan treated as a group health plan under section 732(d) of such Act or defined as such a plan under section 607(1) of such Act.</text></paragraph> <paragraph id="HEF7FD581C3134376BA4E255B9FFAA9E1"><enum>(4)</enum><header>Health care professional</header><text>The term <term>health care professional</term> means an individual who is licensed, accredited, or certified under State law to provide specified health care services and who is operating within the scope of such licensure, accreditation, or certification.</text></paragraph> <paragraph id="H9A8C83DB67F44BB90000CD3614ECA42E"><enum>(5)</enum><header>Health care provider</header><text>The term <term>health care provider</term> includes a physician or other health care professional, as well as an institutional or other facility or agency that provides health care services and that is licensed, accredited, or certified to provide health care items and services under applicable State law.</text></paragraph> <paragraph id="HEACA137D0FDC4BF6885D4C61FFF5A052"><enum>(6)</enum><header>Network</header><text>The term <term>network</term> means, with respect to a group health plan or health insurance issuer offering health insurance coverage, the participating health care professionals and providers through whom the plan or issuer provides health care items and services to participants, beneficiaries, or enrollees.</text></paragraph> <paragraph id="H907F547932AC4279AE36E85CC9947066"><enum>(7)</enum><header>Nonparticipating</header><text>The term <term>nonparticipating</term> means, with respect to a health care provider that provides health care items and services to a participant, beneficiary, or enrollee under group health plan or health insurance coverage, a health care provider that is not a participating health care provider with respect to such items and services.</text></paragraph> <paragraph id="HA7EBC3C98EF448EDB8CB166FF7ACF538"><enum>(8)</enum><header>Participating</header><text>The term <term>participating</term> means, with respect to a health care provider that provides health care items and services to a participant, beneficiary, or enrollee under group health plan or health insurance coverage offered by a health insurance issuer, a health care provider that furnishes such items and services under a contract or other arrangement with the plan or issuer.</text></paragraph> <paragraph id="H59C429D097894F2D0022842DACF80000"><enum>(9)</enum><header>Prior authorization</header><text>The term <term>prior authorization</term> means the process of obtaining prior approval from a health insurance issuer or group health plan for the provision or coverage of medical services.</text></paragraph> <paragraph id="HFAF0BF25C92141C09DBA133719EF0085"><enum>(10)</enum><header>Terms and conditions</header><text>The term <term>terms and conditions</term> includes, with respect to a group health plan or health insurance coverage, requirements imposed under this title with respect to the plan or coverage.</text></paragraph></subsection></section> <section id="HC670E06E47EF48D882558B34BCE200D3"><enum>152.</enum><header>Preemption; State flexibility; construction</header> <subsection id="H375E761A628548E89F00C7D8CBBAB555"><enum>(a)</enum><header>Continued applicability of State law with respect to health insurance issuers</header> <paragraph id="H5E27FA9DA2294DC39F3BC546731B0973"><enum>(1)</enum><header>In general</header><text>Subject to paragraph (2), this title shall not be construed to supersede any provision of State law which establishes, implements, or continues in effect any standard or requirement solely relating to health insurance issuers (in connection with group health insurance coverage or otherwise) except to the extent that such standard or requirement prevents the application of a requirement of this title.</text></paragraph> <paragraph id="HB3256D144DE34BBF825F2B9122C65E06"><enum>(2)</enum><header>Continued preemption with respect to group health plans</header><text>Nothing in this title shall be construed to affect or modify the provisions of section 514 of the <act-name parsable-cite="ERISA">Employee Retirement Income Security Act of 1974</act-name> with respect to group health plans.</text></paragraph> <paragraph id="HAD4D37237D094E7984CEFB086FEF3EE0"><enum>(3)</enum><header>Construction</header><text>In applying this section, a State law that provides for equal access to, and availability of, all categories of licensed health care providers and services shall not be treated as preventing the application of any requirement of this title.</text></paragraph></subsection> <subsection id="HD558BE3C93104389008CC6D0419B3BFB"><enum>(b)</enum><header>Application of substantially compliant State laws</header> <paragraph id="H7D1BE7010EB64EB7BF9DABE65096CE71"><enum>(1)</enum><header>In general</header><text>In the case of a State law that imposes, with respect to health insurance coverage offered by a health insurance issuer and with respect to a group health plan that is a non-Federal governmental plan, a requirement that substantially complies (within the meaning of subsection (c)) with a patient protection requirement (as defined in paragraph (3)) and does not prevent the application of other requirements under this Act (except in the case of other substantially compliant requirements), in applying the requirements of this title under section 2707 and 2753 (as applicable) of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name> (as added by title II), subject to subsection (a)(2)—</text> <subparagraph id="H2CC21BD77D5F41B4B89066B345907CA1"><enum>(A)</enum><text>the State law shall not be treated as being superseded under subsection (a); and</text></subparagraph> <subparagraph id="H65C7FD89507547D18F71F8545897DADB"><enum>(B)</enum><text>the State law shall apply instead of the patient protection requirement otherwise applicable with respect to health insurance coverage and non-Federal governmental plans.</text></subparagraph></paragraph> <paragraph id="H35CE3F2C0BC34A09981D23B59FFAE477"><enum>(2)</enum><header>Limitation</header><text>In the case of a group health plan covered under title I of the <act-name parsable-cite="ERISA">Employee Retirement Income Security Act of 1974</act-name>, paragraph (1) shall be construed to apply only with respect to the health insurance coverage (if any) offered in connection with the plan.</text></paragraph> <paragraph id="HBFB14CB73B404250B8BC5425482E8F16"><enum>(3)</enum><header>Definitions</header><text>In this section:</text> <subparagraph id="HB83FCE9E295F48819E6C4BA287C24708"><enum>(A)</enum><header>Patient protection requirement</header><text>The term <term>patient protection requirement</term> means a requirement under this title, and includes (as a single requirement) a group or related set of requirements under a section or similar unit under this title.</text></subparagraph> <subparagraph id="H1B612EBF8B82442E9CFA4EF105527AD"><enum>(B)</enum><header>Substantially compliant</header><text>The terms “substantially compliant”, substantially complies”, or “substantial compliance” with respect to a State law, mean that the State law has the same or similar features as the patient protection requirements and has a similar effect.</text></subparagraph></paragraph></subsection> <subsection id="H64FF087AEE7B4BC49DECD154F6C400B0"><enum>(c)</enum><header>Determinations of substantial compliance</header> <paragraph id="HD08C9499952E4B01BEF6F738B1E409B6"><enum>(1)</enum><header>Certification by States</header><text>A State may submit to the Secretary a certification that a State law provides for patient protections that are at least substantially compliant with one or more patient protection requirements. Such certification shall be accompanied by such information as may be required to permit the Secretary to make the determination described in paragraph (2)(A).</text></paragraph> <paragraph id="H90815646D6A34F9E98F0816320009290"><enum>(2)</enum><header>Review</header> <subparagraph id="H21FED3A9565F4703AEC4ABDAE4DFB885"><enum>(A)</enum><header>In general</header><text>The Secretary shall promptly review a certification submitted under paragraph (1) with respect to a State law to determine if the State law substantially complies with the patient protection requirement (or requirements) to which the law relates.</text></subparagraph> <subparagraph id="HD82C782E3569475895C89EC58C5DA6DA"><enum>(B)</enum><header>Approval deadlines</header> <clause id="HE275C75E801C4E7797F9582B62CD964F"><enum>(i)</enum><header>Initial review</header><text>Such a certification is considered approved unless the Secretary notifies the State in writing, within 90 days after the date of receipt of the certification, that the certification is disapproved (and the reasons for disapproval) or that specified additional information is needed to make the determination described in subparagraph (A).</text></clause> <clause id="H383CF3DDBD0B465A95C9C700D9D4F2D"><enum>(ii)</enum><header>Additional information</header><text>With respect to a State that has been notified by the Secretary under clause (i) that specified additional information is needed to make the determination described in subparagraph (A), the Secretary shall make the determination within 60 days after the date on which such specified additional information is received by the Secretary.</text></clause></subparagraph></paragraph> <paragraph id="H0E242B6964764910B185349E7DCC81F9"><enum>(3)</enum><header>Approval</header> <subparagraph id="HB495173505B847F583DC02EC6EA0F8E7"><enum>(A)</enum><header>In general</header><text>The Secretary shall approve a certification under paragraph (1) unless—</text> <clause id="H4E9B185083A0417BA5C5E5BF25827300"><enum>(i)</enum><text>the State fails to provide sufficient information to enable the Secretary to make a determination under paragraph (2)(A); or</text></clause> <clause id="H2D22B86805C54EB381A1AE38D8002C4E"><enum>(ii)</enum><text>the Secretary determines that the State law involved does not provide for patient protections that substantially comply with the patient protection requirement (or requirements) to which the law relates.</text></clause></subparagraph> <subparagraph id="H945C3CCCA3A74392971540EA80A22935"><enum>(B)</enum><header>State challenge</header><text>A State that has a certification disapproved by the Secretary under subparagraph (A) may challenge such disapproval in the appropriate United States district court.</text></subparagraph> <subparagraph id="HF82349533AA1488900CA935394C6EED3"><enum>(C)</enum><header>Deference to States</header><text>With respect to a certification submitted under paragraph (1), the Secretary shall give deference to the State’s interpretation of the State law involved with respect to the patient protection involved.</text></subparagraph> <subparagraph id="HBFBF92C4297D4D2BB3A059B5A075FE98"><enum>(D)</enum><header>Public notification</header><text>The Secretary shall—</text> <clause id="H781851F6669B46E58E7092BE447D009D"><enum>(i)</enum><text>provide a State with a notice of the determination to approve or disapprove a certification under this paragraph;</text></clause> <clause id="H4C367D17F48E42A38186FBBECAC2447"><enum>(ii)</enum><text>promptly publish in the Federal Register a notice that a State has submitted a certification under paragraph (1);</text></clause> <clause id="H8116BC0DCC8748F6B2E74864FFC3A9E3"><enum>(iii)</enum><text>promptly publish in the Federal Register the notice described in clause (i) with respect to the State; and</text></clause> <clause id="HCA8574B3856C43D2A9B335110032BF52"><enum>(iv)</enum><text>annually publish the status of all States with respect to certifications.</text></clause></subparagraph></paragraph> <paragraph id="HEE84DE85D318467E8CA3BB89F24CD089"><enum>(4)</enum><header>Construction</header><text>Nothing in this subsection shall be construed as preventing the certification (and approval of certification) of a State law under this subsection solely because it provides for greater protections for patients than those protections otherwise required to establish substantial compliance.</text></paragraph> <paragraph id="H5910612D1B284AA6A62986867267A209"><enum>(5)</enum><header>Petitions</header> <subparagraph id="H872876F6CCB14A69AE5486099D76CB35"><enum>(A)</enum><header>Petition process</header><text>Effective on the date on which the provisions of this Act become effective, as provided for in section 601, a group health plan, health insurance issuer, participant, beneficiary, or enrollee may submit a petition to the Secretary for an advisory opinion as to whether or not a standard or requirement under a State law applicable to the plan, issuer, participant, beneficiary, or enrollee that is not the subject of a certification under this subsection, is superseded under subsection (a)(1) because such standard or requirement prevents the application of a requirement of this title.</text></subparagraph> <subparagraph id="HEA5944E8A64A433488FEC00ABD4E4C4"><enum>(B)</enum><header>Opinion</header><text>The Secretary shall issue an advisory opinion with respect to a petition submitted under subparagraph (A) within the 60-day period beginning on the date on which such petition is submitted.</text></subparagraph></paragraph></subsection> <subsection id="HF0038505ACBF41FEB7BF68D580E9734C"><enum>(d)</enum><header>Definitions</header><text>For purposes of this section:</text> <paragraph id="H80407DDF4BB14569A9A97808AE51D545"><enum>(1)</enum><header>State law</header><text>The term <term>State law</term> includes all laws, decisions, rules, regulations, or other State action having the effect of law, of any State. A law of the United States applicable only to the District of Columbia shall be treated as a State law rather than a law of the United States.</text></paragraph> <paragraph id="H102C25FCB7264CC499C319A61844E4AF"><enum>(2)</enum><header>State</header><text>The term <term>State</term> includes a State, the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, the Northern Mariana Islands, any political subdivisions of such, or any agency or instrumentality of such.</text></paragraph></subsection></section> <section id="HE1C39FF8135249ECBD856C18A46DA472"><enum>153.</enum><header>Exclusions</header> <subsection id="H63B6D4CFDC464596A4B7FC2CB52FDD6D"><enum>(a)</enum><header>No benefit requirements</header><text>Nothing in this title shall be construed to require a group health plan or a health insurance issuer offering health insurance coverage to include specific items and services under the terms of such a plan or coverage, other than those provided under the terms and conditions of such plan or coverage.</text></subsection> <subsection id="HC5F1DDE3C68742BDBEAA8D026C8F4C00"><enum>(b)</enum><header>Exclusion from access to care managed care provisions for fee-for-service coverage</header> <paragraph id="HBA3FB69547FC4A8500905E2EC5CD994"><enum>(1)</enum><header>In general</header><text>The provisions of sections 111 through 117 shall not apply to a group health plan or health insurance coverage if the only coverage offered under the plan or coverage is fee-for-service coverage (as defined in paragraph (2)).</text></paragraph> <paragraph id="H3538BFAFEC444F92B512C9AB6015ADDB"><enum>(2)</enum><header>Fee-for-service coverage defined</header><text>For purposes of this subsection, the term <term>fee-for-service coverage</term> means coverage under a group health plan or health insurance coverage that—</text> <subparagraph id="H48E88BEE689D4A67B3BA5C6FE7E3A224"><enum>(A)</enum><text>reimburses hospitals, health professionals, and other providers on a fee-for-service basis without placing the provider at financial risk;</text></subparagraph> <subparagraph id="H2B6CB7D02B8A4AB488FBA3454916425B"><enum>(B)</enum><text>does not vary reimbursement for such a provider based on an agreement to contract terms and conditions or the utilization of health care items or services relating to such provider;</text></subparagraph> <subparagraph id="HE71D24BCDCE9426185D958AC98EC8C6C"><enum>(C)</enum><text>allows access to any provider that is lawfully authorized to provide the covered services and that agrees to accept the terms and conditions of payment established under the plan or by the issuer; and</text></subparagraph> <subparagraph id="HA93190654FA84048AE23BC22188CC42C"><enum>(D)</enum><text>for which the plan or issuer does not require prior authorization before providing for any health care services.</text></subparagraph></paragraph></subsection></section> <section id="HADE17C59D1BD46959E2CBECC1B402481"><enum>154.</enum><header>Treatment of excepted benefits</header> <subsection id="HA001E8A2DF254D97B73FD89152C7B90"><enum>(a)</enum><header>In general</header><text>The requirements of this title and the provisions of sections 502(a)(1)(C), 502(n), and 514(d) of the <act-name parsable-cite="ERISA">Employee Retirement Income Security Act of 1974</act-name> (added by section 402) shall not apply to excepted benefits (as defined in section 733(c) of such Act), other than benefits described in section 733(c)(2)(A) of such Act, in the same manner as the provisions of part 7 of subtitle B of title I of such Act do not apply to such benefits under subsections (b) and (c) of section 732 of such Act.</text></subsection> <subsection id="H6C61E937E4C04D21AB7D82164624D5AB"><enum>(b)</enum><header>Coverage of certain limited scope plans</header><text>Only for purposes of applying the requirements of this title under sections 2707 and 2753 of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name>, section 714 of the <act-name parsable-cite="ERISA">Employee Retirement Income Security Act of 1974</act-name>, and <external-xref legal-doc="usc" parsable-cite="usc/26/9813">section 9813</external-xref> of the Internal Revenue Code of 1986, the following sections shall be deemed not to apply:</text> <paragraph id="H53C5320A4F464504A54745EB65217265"><enum>(1)</enum><text>Section 2791(c)(2)(A) of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name>.</text></paragraph> <paragraph id="H6FBC6B39960B49FB9CD393324B37AB07"><enum>(2)</enum><text>Section 733(c)(2)(A) of the <act-name parsable-cite="ERISA">Employee Retirement Income Security Act of 1974</act-name>.</text></paragraph> <paragraph id="H17630CFAF39C4D10979E36CCE0A34C82"><enum>(3)</enum><text><external-xref legal-doc="usc" parsable-cite="usc/26/9832">Section 9832(c)(2)(A)</external-xref> of the Internal Revenue Code of 1986.</text></paragraph></subsection></section> <section id="HAD4D1701579748BE0038B4B3512832A1"><enum>155.</enum><header>Regulations</header><text display-inline="no-display-inline">The Secretaries of Health and Human Services, Labor, and the Treasury shall issue such regulations as may be necessary or appropriate to carry out this title. Such regulations shall be issued consistent with section 104 of <act-name parsable-cite="HIPAA">Health Insurance Portability and Accountability Act of 1996</act-name>. Such Secretaries may promulgate any interim final rules as the Secretaries determine are appropriate to carry out this title.</text></section> <section id="H8741DF706A1841F3AC37CC62DB19F91"><enum>156.</enum><header>Incorporation into plan or coverage documents</header><text display-inline="no-display-inline">The requirements of this title with respect to a group health plan or health insurance coverage are, subject to section 154, deemed to be incorporated into, and made a part of, such plan or the policy, certificate, or contract providing such coverage and are enforceable under law as if directly included in the documentation of such plan or such policy, certificate, or contract.</text></section> <section id="H86703E90F1D349249FA686F7C22B32E9"><enum>157.</enum><header>Preservation of protections</header> <subsection id="HC86BBB81E52F45D38C8985AC3BFEEF4E"><enum>(a)</enum><header>In general</header><text>The rights under this Act (including the right to maintain a civil action and any other rights under the amendments made by this Act) may not be waived, deferred, or lost pursuant to any agreement not authorized under this Act.</text></subsection> <subsection id="H788DEEECDCDB479C8900F28424EB8D04"><enum>(b)</enum><header>Exception</header><text>Subsection (a) shall not apply to an agreement providing for arbitration or participation in any other nonjudicial procedure to resolve a dispute if the agreement—</text> <paragraph id="H0E9308D605B04608908501A2EBCE72C0"><enum>(1)</enum><text>is entered into knowingly and voluntarily by the parties involved after the dispute has arisen; or</text></paragraph> <paragraph id="H9FF7BA3BA26D407CB5E5865EF34238E"><enum>(2)</enum><text>is pursuant to the terms of a collective bargaining agreement.</text></paragraph><continuation-text continuation-text-level="subsection">Nothing in this subsection shall be construed to permit the waiver of the requirements of sections 103 and 104 (relating to internal and external review).</continuation-text></subsection></section></subtitle> <enum>II</enum><header>Application of quality care standards to group health plans and health insurance coverage under the <act-name parsable-cite="PHSA">Public Health Service Act</act-name></header> <section id="H275D1908DE6645A3A5E3D502225364A4"><enum>201.</enum><header>Application to group health plans and group health insurance coverage</header> <subsection id="HAF3231A50CD740C7AFF4EE618B5DE2BD"><enum>(a)</enum><header>In general</header><text>Subpart 2 of part A of title XXVII of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name> is amended by adding at the end the following new section:</text> <quoted-block act-name="Public Health Service Act" id="HB6AB856E4D2E4668B3006D3CEFEBF8C"> <section id="H013FAE75221B497AAE3E787D43AC84A6"><enum>2707.</enum><header>Patient protection standards</header><text display-inline="no-display-inline">Each group health plan shall comply with patient protection requirements under title I of the <short-title>Patients’ Bill of Rights Act of 2005</short-title>, and each health insurance issuer shall comply with patient protection requirements under such title with respect to group health insurance coverage it offers, and such requirements shall be deemed to be incorporated into this subsection.</text></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="HACBB43A0C9A447ABB087B59D00790731"><enum>(b)</enum><header>Conforming amendment</header><text>Section 2721(b)(2)(A) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg-21">42 U.S.C. 300gg–21(b)(2)(A)</external-xref>) is amended by inserting <quote>(other than section 2707)</quote> after <quote>requirements of such subparts</quote>.</text></subsection></section> <section id="HCEFFED7E5841432E9462FB6800306829"><enum>202.</enum><header>Application to individual health insurance coverage</header><text display-inline="no-display-inline">Part B of title XXVII of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name> is amended by inserting after section 2752 the following new section:</text> <quoted-block act-name="Public Health Service Act" id="H7530DC2DA47E402BB6E820CFE8F7F3D6"> <section id="H1C86625C7F5D4DCBA130EA672E8EC00"><enum>2753.</enum><header>Patient protection standards</header><text display-inline="no-display-inline">Each health insurance issuer shall comply with patient protection requirements under title I of the <short-title>Patients’ Bill of Rights Act of 2005</short-title> with respect to individual health insurance coverage it offers, and such requirements shall be deemed to be incorporated into this subsection.</text></section><after-quoted-block>.</after-quoted-block></quoted-block></section> <section id="HCADD96DF8E0B4DB4B1F91D2F009780B8"><enum>203.</enum><header>Cooperation between Federal and State authorities</header><text display-inline="no-display-inline">Part C of title XXVII of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg-91">42 U.S.C. 300gg–91 et seq.</external-xref>) is amended by adding at the end the following:</text> <quoted-block act-name="Public Health Service Act" id="H77D6D37C1DF74EBA9B8B4BF4938600FC"> <section id="H2BA4CADD2FD7498898F0083CB31E300"><enum>2793.</enum><header>Cooperation between Federal and State authorities</header> <subsection id="HD4621AAEAC4D49169042426EC80000E2"><enum>(a)</enum><header>Agreement with States</header><text>A State may enter into an agreement with the Secretary for the delegation to the State of some or all of the Secretary’s authority under this title to enforce the requirements applicable under title I of the <short-title>Patients’ Bill of Rights Act of 2005</short-title> with respect to health insurance coverage offered by a health insurance issuer and with respect to a group health plan that is a non-Federal governmental plan.</text></subsection> <subsection id="H270CB369D5294246BF041827C56D8E72"><enum>(b)</enum><header>Delegations</header><text>Any department, agency, or instrumentality of a State to which authority is delegated pursuant to an agreement entered into under this section may, if authorized under State law and to the extent consistent with such agreement, exercise the powers of the Secretary under this title which relate to such authority.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section> <enum>III</enum><header>Application of patient protection standards to Federal health insurance programs</header> <section id="HDF3ED6558D824D97B1E27244BB570969"><enum>301.</enum><header>Application of patient protection standards to Federal health insurance programs</header> <subsection id="HEA25FAF09141424799899498BEA458D2"><enum>(a)</enum><header>Sense of Congress</header><text>It is the sense of Congress that enrollees in Federal health insurance programs should have the same rights and privileges as those afforded under title I and under the amendments made by title IV to participants and beneficiaries under group health plans.</text></subsection> <subsection id="H27EBC827BCF04AB2AC3F21F7AF23D140"><enum>(b)</enum><header>Conforming Federal health insurance programs</header><text>It is the sense of Congress that the President should require, by executive order, the Federal official with authority over each Federal health insurance program, to the extent feasible, to take such steps as are necessary to implement the rights and privileges described in subsection (a) with respect to such program.</text></subsection> <subsection id="H33BD5798E4504CB1BBFB534EECAF37E7"><enum>(c)</enum><header>GAO report on additional steps required</header><text>Not later than 1 year after the date of the enactment of this Act, the Comptroller General of the United States shall submit to Congress a report on statutory changes that are required to implement such rights and privileges in a manner that is consistent with the missions of the Federal health insurance programs and that avoids unnecessary duplication or disruption of such programs.</text></subsection> <subsection id="H291DCB81142F4B4392FD2E739B73F04E"><enum>(d)</enum><header>Federal health insurance program</header><text>In this section, the term <term>Federal health insurance program</term> means a Federal program that provides creditable coverage (as defined in section 2701(c)(1) of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name>) and includes a health program of the Department of Veterans Affairs.</text></subsection></section> <enum>IV</enum><header>Amendments to the <act-name parsable-cite="ERISA">Employee Retirement Income Security Act of 1974</act-name></header> <section id="H35E797B3B4DD40C2AE6368B24DA05B76"><enum>401.</enum><header>Application of patient protection standards to group health plans and group health insurance coverage under the <act-name parsable-cite="ERISA">Employee Retirement Income Security Act of 1974</act-name></header><text display-inline="no-display-inline">Subpart B of part 7 of subtitle B of title I of the <act-name parsable-cite="ERISA">Employee Retirement Income Security Act of 1974</act-name> is amended by adding at the end the following new section:</text> <quoted-block act-name="Employee Retirement Income Security Act of 1974" id="H6D360BC5A4DA41C2BE4946DE08E000DA"> <section id="HEDB4427CB56A453C8B46899397554183"><enum>714.</enum><header>Patient protection standards</header> <subsection id="H8EB00F96791E4B5C00ECC6937EFA834D"><enum>(a)</enum><header>In general</header><text>Subject to subsection (b), a group health plan (and a health insurance issuer offering group health insurance coverage in connection with such a plan) shall comply with the requirements of title I of the <short-title>Patients’ Bill of Rights Act of 2005</short-title> (as in effect as of the date of the enactment of such Act), and such requirements shall be deemed to be incorporated into this subsection.</text></subsection> <subsection id="HF511F4ABF0B4494EAA12BF045BCEF64"><enum>(b)</enum><header>Plan satisfaction of certain requirements</header> <paragraph id="H6EEF554A54354FCE8FA4AC14A8A1BE52"><enum>(1)</enum><header>Satisfaction of certain requirements through insurance</header><text>For purposes of subsection (a), insofar as a group health plan provides benefits in the form of health insurance coverage through a health insurance issuer, the plan shall be treated as meeting the following requirements of title I of the <short-title>Patients’ Bill of Rights Act of 2005</short-title> with respect to such benefits and not be considered as failing to meet such requirements because of a failure of the issuer to meet such requirements so long as the plan sponsor or its representatives did not cause such failure by the issuer:</text> <subparagraph id="HB05753BD2ADB4D8ABF9FA5CFE196D3CC"><enum>(A)</enum><text>Section 111 (relating to consumer choice option).</text></subparagraph> <subparagraph id="H9EC2D2F907FB4B3CBFC15B6D6D576328"><enum>(B)</enum><text>Section 112 (relating to choice of health care professional).</text></subparagraph> <subparagraph id="H68E00799837B43269F521BD978891472"><enum>(C)</enum><text>Section 113 (relating to access to emergency care).</text></subparagraph> <subparagraph id="H7419334678034C3198616B90001384D"><enum>(D)</enum><text>Section 114 (relating to timely access to specialists).</text></subparagraph> <subparagraph id="H36872695ED8B48C792428B27C66596C5"><enum>(E)</enum><text>Section 115 (relating to patient access to obstetrical and gynecological care).</text></subparagraph> <subparagraph id="HAD2ECF7EDE4148B0AD29A2D78C636CE8"><enum>(F)</enum><text>Section 116 (relating to access to pediatric care).</text></subparagraph> <subparagraph id="H41D5D187FBB7489EBA82EB00D44646DA"><enum>(G)</enum><text>Section 117 (relating to continuity of care), but only insofar as a replacement issuer assumes the obligation for continuity of care.</text></subparagraph> <subparagraph id="HD69EDB6D0AC843C880B391212FF70EC"><enum>(H)</enum><text>Section 118 (relating to access to needed prescription drugs).</text></subparagraph> <subparagraph id="H9600C3D1E72942618E53699D15897C9B"><enum>(I)</enum><text>Section 119 (relating to coverage for individuals participating in approved clinical trials).</text></subparagraph> <subparagraph id="H21D146D0A33044E98FEDE222F23002C"><enum>(J)</enum><text>Section 120 (relating to required coverage for minimum hospital stay for mastectomies and lymph node dissections for the treatment of breast cancer and coverage for secondary consultations).</text></subparagraph> <subparagraph id="H393B99B969734831BC0055082C70E06D"><enum>(K)</enum><text>Section 134 (relating to payment of claims).</text></subparagraph></paragraph> <paragraph id="H6C64921AB11B46E188DDA883A715CF85"><enum>(2)</enum><header>Information</header><text>With respect to information required to be provided or made available under section 121 of the <short-title>Patients’ Bill of Rights Act of 2005</short-title>, in the case of a group health plan that provides benefits in the form of health insurance coverage through a health insurance issuer, the Secretary shall determine the circumstances under which the plan is not required to provide or make available the information (and is not liable for the issuer’s failure to provide or make available the information), if the issuer is obligated to provide and make available (or provides and makes available) such information.</text></paragraph> <paragraph id="HA5A2737B70FE4FC196295CE1BD50B49F"><enum>(3)</enum><header>Internal appeals</header><text>With respect to the internal appeals process required to be established under section 103 of such Act, in the case of a group health plan that provides benefits in the form of health insurance coverage through a health insurance issuer, the Secretary shall determine the circumstances under which the plan is not required to provide for such process and system (and is not liable for the issuer’s failure to provide for such process and system), if the issuer is obligated to provide for (and provides for) such process and system.</text></paragraph> <paragraph id="H517196D1A18547B688795C637C580031"><enum>(4)</enum><header>External appeals</header><text>Pursuant to rules of the Secretary, insofar as a group health plan enters into a contract with a qualified external appeal entity for the conduct of external appeal activities in accordance with section 104 of such Act, the plan shall be treated as meeting the requirement of such section and is not liable for the entity’s failure to meet any requirements under such section.</text></paragraph> <paragraph id="H626195B5AEB541E2B6E486151274CCA1"><enum>(5)</enum><header>Application to prohibitions</header><text>Pursuant to rules of the Secretary, if a health insurance issuer offers health insurance coverage in connection with a group health plan and takes an action in violation of any of the following sections of the <short-title>Patients’ Bill of Rights Act of 2005</short-title>, the group health plan shall not be liable for such violation unless the plan caused such violation:</text> <subparagraph id="HB86E7BB946E34FD7AA18A5F5CB6BCA13"><enum>(A)</enum><text>Section 131 (relating to prohibition of interference with certain medical communications).</text></subparagraph> <subparagraph id="HBCDD40A05E9640C6ADB1A1E6AD3E897B"><enum>(B)</enum><text>Section 132 (relating to prohibition of discrimination against providers based on licensure).</text></subparagraph> <subparagraph id="H8254CB6064B14BE38E38CEA63E9205BB"><enum>(C)</enum><text>Section 133 (relating to prohibition against improper incentive arrangements).</text></subparagraph> <subparagraph id="H6BA3917B45B246E88363E241BCAB1FAA"><enum>(D)</enum><text>Section 135 (relating to protection for patient advocacy).</text></subparagraph></paragraph> <paragraph id="H9B265BE0A4BB406B918D47CA09931628"><enum>(6)</enum><header>Construction</header><text>Nothing in this subsection shall be construed to affect or modify the responsibilities of the fiduciaries of a group health plan under part 4 of subtitle B.</text></paragraph> <paragraph id="H120B3E5D6A4840FA8E6F93E59EFF81F1"><enum>(7)</enum><header>Treatment of substantially compliant State laws</header><text>For purposes of applying this subsection in connection with health insurance coverage, any reference in this subsection to a requirement in a section or other provision in the <short-title>Patients’ Bill of Rights Act of 2005</short-title> with respect to a health insurance issuer is deemed to include a reference to a requirement under a State law that substantially complies (as determined under section 152(c) of such Act) with the requirement in such section or other provisions.</text></paragraph> <paragraph id="HEB7133ABF3CC45E7B5FDFA7693003B5"><enum>(8)</enum><header>Application to certain prohibitions against retaliation</header><text>With respect to compliance with the requirements of section 135(b)(1) of the <short-title>Patients’ Bill of Rights Act of 2005</short-title>, for purposes of this subtitle the term <term>group health plan</term> is deemed to include a reference to an institutional health care provider.</text></paragraph></subsection> <subsection id="H1DAC704FC659439AAB56840471EFAC84"><enum>(c)</enum><header>Enforcement of certain requirements</header> <paragraph id="HD4CD5B47F56E4DDCA9BE6ED501D6FB8F"><enum>(1)</enum><header>Complaints</header><text>Any protected health care professional who believes that the professional has been retaliated or discriminated against in violation of section 135(b)(1) of the <short-title>Patients’ Bill of Rights Act of 2005</short-title> may file with the Secretary a complaint within 180 days of the date of the alleged retaliation or discrimination.</text></paragraph> <paragraph id="H46487B6D06A14ED88EFD689B0010B900"><enum>(2)</enum><header>Investigation</header><text>The Secretary shall investigate such complaints and shall determine if a violation of such section has occurred and, if so, shall issue an order to ensure that the protected health care professional does not suffer any loss of position, pay, or benefits in relation to the plan, issuer, or provider involved, as a result of the violation found by the Secretary.</text></paragraph></subsection> <subsection id="H64D35039C2FB4545845707CFC41C5E6F"><enum>(d)</enum><header>Conforming regulations</header><text>The Secretary shall issue regulations to coordinate the requirements on group health plans and health insurance issuers under this section with the requirements imposed under the other provisions of this title. In order to reduce duplication and clarify the rights of participants and beneficiaries with respect to information that is required to be provided, such regulations shall coordinate the information disclosure requirements under section 121 of the <short-title>Patients’ Bill of Rights Act of 2005</short-title> with the reporting and disclosure requirements imposed under part 1, so long as such coordination does not result in any reduction in the information that would otherwise be provided to participants and beneficiaries.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block> <subsection id="H5E6639EB21D64661B5B24C7482F3CDB2"><enum>(b)</enum><header>Satisfaction of ERISA claims procedure requirement</header><text>Section 503 of such Act (<external-xref legal-doc="usc" parsable-cite="usc/29/1133">29 U.S.C. 1133</external-xref>) is amended by inserting <quote>(a)</quote> after <quote>Sec. 503.</quote> and by adding at the end the following new subsection:</text> <quoted-block id="HE1916EA33343410A9CDCADDCC423D29"> <subsection id="H9AA1382D11374C5099EDA6A55B83C7CE"><enum>(b)</enum><text>In the case of a group health plan (as defined in section 733), compliance with the requirements of subtitle A of title I of the <short-title>Patients’ Bill of Rights Act of 2005</short-title>, and compliance with regulations promulgated by the Secretary, in the case of a claims denial, shall be deemed compliance with subsection (a) with respect to such claims denial.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="HE1C94B66DFBA4B2CB348CF2EA06D8EAB"><enum>(c)</enum><header>Conforming amendments</header> <paragraph display-inline="yes-display-inline" id="H37540BCBA77B488EA4EBA8834200D81E"><enum>(1)</enum><text>Section 732(a) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/29/1185">29 U.S.C. 1185(a)</external-xref>) is amended by striking <quote>section 711</quote> and inserting <quote>sections 711 and 714</quote>.</text></paragraph> <paragraph indent="up1" id="H4A966F18FFD8461B9518D90085DF48DC"><enum>(2)</enum><text>The table of contents in section 1 of such Act is amended by inserting after the item relating to section 713 the following new item:</text> <quoted-block style="USC" id="HFF21D989864E4FE8B3872C66574309A8"> <toc regeneration="no-regeneration"> <toc-entry level="section">714. Patient protection standards</toc-entry></toc><after-quoted-block>.</after-quoted-block></quoted-block></paragraph> <paragraph indent="up1" id="H9DCA9844DCA0436C9C1599D9F39DE084"><enum>(3)</enum><text>Section 502(b)(3) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/29/1132">29 U.S.C. 1132(b)(3)</external-xref>) is amended by inserting <quote>(other than section 135(b) of the Patients’ Bill of Rights Act of 2005, as deemed by subsection (a) of section 714 of this Act to be incorporated into such subsection)</quote> after <quote>part 7</quote>.</text></paragraph></subsection></section> <section id="H94AA19D80E3A40AA9173EF25D417E7A9"><enum>402.</enum><header>Availability of civil remedies</header> <subsection id="HD11DA1A4B0514391A9EB736AA861E5F"><enum>(a)</enum><header>Availability of Federal civil remedies in cases not involving medically reviewable decisions</header> <paragraph id="H0DAD03FEAE814C99A308F8433100CDCD"><enum>(1)</enum><header>In general</header><text>Section 502 of the <act-name parsable-cite="ERISA">Employee Retirement Income Security Act of 1974</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/29/1132">29 U.S.C. 1132</external-xref>) is amended by adding at the end the following new subsections:</text> <quoted-block act-name="Employee Retirement Income Security Act of 1974" id="HF4E750956F6A426AB5BE333B9F9FC8D"> <subsection id="H8DAA6F194C75488F891D5E28B8DD7910"><enum>(n)</enum><header>Cause of action relating to provision of health benefits</header> <paragraph id="HF63AFCBD4F69407794B52DBEA5EC411"><enum>(1)</enum><header>In general</header><text>In any case in which—</text> <subparagraph id="HF203501C846D49359B3D80C2CF0095D0"><enum>(A)</enum><text>a person who is a fiduciary of a group health plan, a health insurance issuer offering health insurance coverage in connection with the plan, or an agent of the plan, issuer, or plan sponsor, upon consideration of a claim for benefits of a participant or beneficiary under section 102 of the <short-title>Patients’ Bill of Rights Act of 2005</short-title> (relating to procedures for initial claims for benefits and prior authorization determinations) or upon review of a denial of such a claim under section 103 of such Act (relating to internal appeal of a denial of a claim for benefits), fails to exercise ordinary care in making a decision—</text> <clause id="HE04B3320796B48E5A19456E030F68D9B"><enum>(i)</enum><text>regarding whether an item or service is covered under the terms and conditions of the plan or coverage,</text></clause> <clause id="HE659FD32867F463ABE7C8054B0079D6C"><enum>(ii)</enum><text>regarding whether an individual is a participant or beneficiary who is enrolled under the terms and conditions of the plan or coverage (including the applicability of any waiting period under the plan or coverage), or</text></clause> <clause id="HBCEBD0276DFB4F14A2A6A7079700A040"><enum>(iii)</enum><text>as to the application of cost-sharing requirements or the application of a specific exclusion or express limitation on the amount, duration, or scope of coverage of items or services under the terms and conditions of the plan or coverage, and</text></clause></subparagraph> <subparagraph id="H4D508CDF467A4CC8A30003262127C912"><enum>(B)</enum><text>such failure is a proximate cause of personal injury to, or the death of, the participant or beneficiary,</text></subparagraph><continuation-text continuation-text-level="paragraph">such plan, plan sponsor, or issuer shall be liable to the participant or beneficiary (or the estate of such participant or beneficiary) for economic and noneconomic damages (but not exemplary or punitive damages) in connection with such personal injury or death.</continuation-text></paragraph> <paragraph id="H549ED23A0F1842E8AA828FC6E51514DD"><enum>(2)</enum><header>Cause of action must not involve medically reviewable decision</header> <subparagraph id="HE0CB8CD6B46A45EDA8EE38E6227EB3B1"><enum>(A)</enum><header>In general</header><text>A cause of action is established under paragraph (1)(A) only if the decision referred to in paragraph (1)(A) does not include a medically reviewable decision.</text></subparagraph> <subparagraph id="HA98DE757A7A34C61A6CB3C7FE1588C8D"><enum>(B)</enum><header>Medically reviewable decision</header><text>For purposes of this subsection, the term <term>medically reviewable decision</term> means a denial of a claim for benefits under the plan which is described in section 104(d)(2) of the <short-title>Patients’ Bill of Rights Act of 2005</short-title> (relating to medically reviewable decisions).</text></subparagraph></paragraph> <paragraph id="HF1C60C692D074F99AE18E3BC49C2EA96"><enum>(3)</enum><header>Limitation regarding certain types of actions saved from preemption of State law</header><text>A cause of action is not established under paragraph (1)(A) in connection with a failure described in paragraph (1)(A) to the extent that a cause of action under State law (as defined in section 514(c)) for such failure would not be preempted under section 514.</text></paragraph> <paragraph id="H3FB289F322CE46058FF0B0C8FE306D4B"><enum>(4)</enum><header>Definitions and related rules</header><text>For purposes of this subsection.—</text> <subparagraph id="H97F5994147D94551B732AEED8C39A2AE"><enum>(A)</enum><header>Ordinary care</header><text>The term <term>ordinary care</term> means, with respect to a determination on a claim for benefits, that degree of care, skill, and diligence that a reasonable and prudent individual would exercise in making a fair determination on a claim for benefits of like kind to the claims involved.</text></subparagraph> <subparagraph id="H83B41359A12C4F4FA94F5841BBC382B"><enum>(B)</enum><header>Personal injury</header><text>The term <term>personal injury</term> means a physical injury and includes an injury arising out of the treatment (or failure to treat) a mental illness or disease.</text></subparagraph> <subparagraph id="H54A8A5916A8A46E4B3BE34FB00FD9CA"><enum>(C)</enum><header>Claim for benefits; denial</header><text>The terms <term>claim for benefits</term> and <term>denial of a claim for benefits</term> have the meanings provided such terms in section 102(e) of the <short-title>Patients’ Bill of Rights Act of 2005</short-title>.</text></subparagraph> <subparagraph id="HE033167F8982467192BC4E2230FF87E8"><enum>(D)</enum><header>Terms and conditions</header><text>The term <term>terms and conditions</term> includes, with respect to a group health plan or health insurance coverage, requirements imposed under title I of the <short-title>Patients’ Bill of Rights Act of 2005</short-title>.</text></subparagraph> <subparagraph id="H24EC6EACDA9E4165A693D031B6019E78"><enum>(E)</enum><header>Treatment of excepted benefits</header><text>Under section 154(a) of the <short-title>Patients’ Bill of Rights Act of 2005</short-title>, the provisions of this subsection and subsection (a)(1)(C) do not apply to certain excepted benefits.</text></subparagraph></paragraph> <paragraph id="HD3688137BB4543E30034B0AC552F072F"><enum>(5)</enum><header>Exclusion of employers and other plan sponsors</header> <subparagraph id="HAF971DC9718D4223866256C18834064F"><enum>(A)</enum><header>Causes of action against employers and plan sponsors precluded</header><text>Subject to subparagraph (B), paragraph (1)(A) does not authorize a cause of action against an employer or other plan sponsor maintaining the plan (or against an employee of such an employer or sponsor acting within the scope of employment).</text></subparagraph> <subparagraph id="H74C3DFB843124EB6987D888060B742B"><enum>(B)</enum><header>Certain causes of action permitted</header><text>Notwithstanding subparagraph (A), a cause of action may arise against an employer or other plan sponsor (or against an employee of such an employer or sponsor acting within the scope of employment) under paragraph (1)(A), to the extent there was direct participation by the employer or other plan sponsor (or employee) in the decision of the plan under section 102 of the <short-title>Patients’ Bill of Rights Act of 2005</short-title> upon consideration of a claim for benefits or under section 103 of such Act upon review of a denial of a claim for benefits.</text></subparagraph> <subparagraph id="H830AD27280FB4294B609CB00F8DF5EC7"><enum>(C)</enum><header>Direct participation</header> <clause id="HEC32212A01054EE8B66F05B0C8A8C0B0"><enum>(i)</enum><header>In general</header><text>For purposes of subparagraph (B), the term <term>direct participation</term> means, in connection with a decision described in paragraph (1)(A), the actual making of such decision or the actual exercise of control in making such decision.</text></clause> <clause id="H489014086BEE4340B9E67D2C9EA69DC2"><enum>(ii)</enum><header>Rules of construction</header><text>For purposes of clause (i), the employer or plan sponsor (or employee) shall not be construed to be engaged in direct participation because of any form of decisionmaking or other conduct that is merely collateral or precedent to the decision described in paragraph (1)(A) on a particular claim for benefits of a participant or beneficiary, including (but not limited to)—</text> <subclause id="HC58DE32E013043F189E05600EB627A3"><enum>(I)</enum><text>any participation by the employer or other plan sponsor (or employee) in the selection of the group health plan or health insurance coverage involved or the third party administrator or other agent;</text></subclause> <subclause id="HDF42305361324E8D987F80DF2D9FA300"><enum>(II)</enum><text>any engagement by the employer or other plan sponsor (or employee) in any cost-benefit analysis undertaken in connection with the selection of, or continued maintenance of, the plan or coverage involved;</text></subclause> <subclause id="HC44143D7EC9C4F5A978300888169B441"><enum>(III)</enum><text>any participation by the employer or other plan sponsor (or employee) in the process of creating, continuing, modifying, or terminating the plan or any benefit under the plan, if such process was not substantially focused solely on the particular situation of the participant or beneficiary referred to in paragraph (1)(A); and</text></subclause> <subclause id="H20D225FE039E486B845562C303794F08"><enum>(IV)</enum><text>any participation by the employer or other plan sponsor (or employee) in the design of any benefit under the plan, including the amount of copayment and limits connected with such benefit.</text></subclause></clause> <clause id="HBDDF0016776C4C56B7F193B1ED0395D8"><enum>(iii)</enum><header>Irrelevance of certain collateral efforts made by employer or plan sponsor</header><text>For purposes of this subparagraph, an employer or plan sponsor shall not be treated as engaged in direct participation in a decision with respect to any claim for benefits or denial thereof in the case of any particular participant or beneficiary solely by reason of—</text> <subclause id="HCD3E79541C044B44BDD1BA1BD7FA801F"><enum>(I)</enum><text>any efforts that may have been made by the employer or plan sponsor to advocate for authorization of coverage for that or any other participant or beneficiary (or any group of participants or beneficiaries), or</text></subclause> <subclause id="HD5C5B533EE3A4B5DB41EC07CD9D67171"><enum>(II)</enum><text>any provision that may have been made by the employer or plan sponsor for benefits which are not covered under the terms and conditions of the plan for that or any other participant or beneficiary (or any group of participants or beneficiaries).</text></subclause></clause></subparagraph> <subparagraph id="H40653CA89D3C4960BDDDBAFEB8ADE6ED"><enum>(D)</enum><header>Application to certain plans</header> <clause id="H914B42AE4F2E457990EEA72904C91506"><enum>(i)</enum><header>In general</header><text>Notwithstanding any other provision of this subsection, no group health plan described in clause (ii) (or plan sponsor of such a plan) shall be liable under paragraph (1) for the performance of, or the failure to perform, any non-medically reviewable duty under the plan.</text></clause> <clause id="HD76A7608EFB142398E49B146064DD0E9"><enum>(ii)</enum><header>Definition</header><text>A group health plan described in this clause is—</text> <subclause id="HA2B5E71D4EFB4B5BAEC942EDB2B5F060"><enum>(I)</enum><text>a group health plan that is self-insured and self administered by an employer (including an employee of such an employer acting within the scope of employment); or</text></subclause> <subclause id="H6EFD731D9CCA4AA19D29B2A8B0D48141"><enum>(II)</enum><text>a multiemployer plan as defined in section 3(37)(A) (including an employee of a contributing employer or of the plan, or a fiduciary of the plan, acting within the scope of employment or fiduciary responsibility) that is self-insured and self-administered.</text></subclause></clause></subparagraph></paragraph> <paragraph id="HC42CAE7399C64823951D00B87B7FCD03"><enum>(6)</enum><header>Exclusion of physicians and other health care professionals</header> <subparagraph id="HC1EF9805CC6F404C8EA115EB021E744D"><enum>(A)</enum><header>In general</header><text>No treating physician or other treating health care professional of the participant or beneficiary, and no person acting under the direction of such a physician or health care professional, shall be liable under paragraph (1) for the performance of, or the failure to perform, any non-medically reviewable duty of the plan, the plan sponsor, or any health insurance issuer offering health insurance coverage in connection with the plan.</text></subparagraph> <subparagraph id="HBE57B455E4F747388260F66193F6C61"><enum>(B)</enum><header>Definitions</header><text>For purposes of subparagraph (A)—</text> <clause id="HEB35DD63879F4DA80092045387396799"><enum>(i)</enum><header>Health care professional</header><text>The term <term>health care professional</term> means an individual who is licensed, accredited, or certified under State law to provide specified health care services and who is operating within the scope of such licensure, accreditation, or certification.</text></clause> <clause id="H03C8889CF3BF48770017065C5F5BD800"><enum>(ii)</enum><header>Non-medically reviewable duty</header><text>The term <term>non-medically reviewable duty</term> means a duty the discharge of which does not include the making of a medically reviewable decision.</text></clause></subparagraph></paragraph> <paragraph id="H5D6FC5BDF49B4CB0AD7984D6526C79F1"><enum>(7)</enum><header>Exclusion of hospitals</header><text>No treating hospital of the participant or beneficiary shall be liable under paragraph (1) for the performance of, or the failure to perform, any non-medically reviewable duty (as defined in paragraph (6)(B)(ii)) of the plan, the plan sponsor, or any health insurance issuer offering health insurance coverage in connection with the plan.</text></paragraph> <paragraph id="HF223C40068F745CEA1A900C227EE1EB4"><enum>(8)</enum><header>Rule of construction relating to exclusion from liability of physicians, health care professionals, and hospitals</header><text>Nothing in paragraph (6) or (7) shall be construed to limit the liability (whether direct or vicarious) of the plan, the plan sponsor, or any health insurance issuer offering health insurance coverage in connection with the plan.</text></paragraph> <paragraph id="H37BE296DCA1B4D66B104CE9D60908C88"><enum>(9)</enum><header>Requirement of exhaustion</header> <subparagraph id="H42474CD810864161808317D0A85BA5B3"><enum>(A)</enum><header>In general</header><text>A cause of action may not be brought under paragraph (1) in connection with any denial of a claim for benefits of any individual until all administrative processes under sections 102 and 103 of the <short-title>Patients’ Bill of Rights Act of 2005</short-title> (if applicable) have been exhausted.</text></subparagraph> <subparagraph id="H2DB793670F534772A2E4EF929FA3A506"><enum>(B)</enum><header>Exception for needed care</header><text>A participant or beneficiary may seek relief exclusively in Federal court under subsection 502(a)(1)(B) prior to the exhaustion of administrative remedies under sections 102, 103, or 104 of the <short-title>Patients’ Bill of Rights Act of 2005</short-title> (as required under subparagraph (A)) if it is demonstrated to the court that the exhaustion of such remedies would cause irreparable harm to the health of the participant or beneficiary. Notwithstanding the awarding of relief under subsection 502(a)(1)(B) pursuant to this subparagraph, no relief shall be available as a result of, or arising under, paragraph (1)(A) or paragraph (10)(B), with respect to a participant or beneficiary, unless the requirements of subparagraph (A) are met.</text></subparagraph> <subparagraph id="H7FF50DA1AE9C4BDA00D6ED434F05B2DB"><enum>(C)</enum><header>Receipt of benefits during appeals process</header><text>Receipt by the participant or beneficiary of the benefits involved in the claim for benefits during the pendency of any administrative processes referred to in subparagraph (A) or of any action commenced under this subsection—</text> <clause id="HA3A9D051C38A494C8D857BD48C622FF7"><enum>(i)</enum><text>shall not preclude continuation of all such administrative processes to their conclusion if so moved by any party, and</text></clause> <clause id="H043F27F5B6334715A0E4E01978636D21"><enum>(ii)</enum><text>shall not preclude any liability under subsection (a)(1)(C) and this subsection in connection with such claim.</text></clause><continuation-text continuation-text-level="subparagraph">The court in any action commenced under this subsection shall take into account any receipt of benefits during such administrative processes or such action in determining the amount of the damages awarded.</continuation-text></subparagraph> <subparagraph id="HE1FC753F41E94612BC0300964C4D0081"><enum>(D)</enum><header>Admissible</header><text>Any determination made by a reviewer in an administrative proceeding under section 103 of the <short-title>Patients’ Bill of Rights Act of 2005</short-title> shall be admissible in any Federal court proceeding and shall be presented to the trier of fact.</text></subparagraph></paragraph> <paragraph id="H050A18A6400F492D9347F67C91407EE1"><enum>(10)</enum><header>Statutory damages</header> <subparagraph id="HD373F8B6558547DE93CFF6DC6BB12950"><enum>(A)</enum><header>In general</header><text>The remedies set forth in this subsection (n) shall be the exclusive remedies for causes of action brought under this subsection.</text></subparagraph> <subparagraph id="H891F3DAB9C6A4513BEC96348678325E9"><enum>(B)</enum><header>Assessment of civil penalties</header><text>In addition to the remedies provided for in paragraph (1) (relating to the failure to provide contract benefits in accordance with the plan), a civil assessment, in an amount not to exceed $5,000,000, payable to the claimant may be awarded in any action under such paragraph if the claimant establishes by clear and convincing evidence that the alleged conduct carried out by the defendant demonstrated bad faith and flagrant disregard for the rights of the participant or beneficiary under the plan and was a proximate cause of the personal injury or death that is the subject of the claim.</text></subparagraph></paragraph> <paragraph id="H627E9A1027BB4D10A5D379B6033B009C"><enum>(11)</enum><header>Limitation on attorneys’ fees</header> <subparagraph id="H2E1E1EF74DAA4D969DF163001DD9C9D1"><enum>(A)</enum><header>In general</header><text>Notwithstanding any other provision of law, or any arrangement, agreement, or contract regarding an attorney’s fee, the amount of an attorney’s contingency fee allowable for a cause of action brought pursuant to this subsection shall not exceed <fraction>1/3</fraction> of the total amount of the plaintiff’s recovery (not including the reimbursement of actual out-of-pocket expenses of the attorney).</text></subparagraph> <subparagraph id="H45310A3E15A540678FF31FB3DDC96FA4"><enum>(B)</enum><header>Determination by district court</header><text>The last Federal district court in which the action was pending upon the final disposition, including all appeals, of the action shall have jurisdiction to review the attorney’s fee to ensure that the fee is a reasonable one.</text></subparagraph></paragraph> <paragraph id="HDA83084348954615BAB42DF3B435659F"><enum>(12)</enum><header>Limitation of action</header><text>Paragraph (1) shall not apply in connection with any action commenced after 3 years after the later of—</text> <subparagraph id="H0F23B88CC5FD4284A91EC1568E4BE4E0"><enum>(A)</enum><text>the date on which the plaintiff first knew, or reasonably should have known, of the personal injury or death resulting from the failure described in paragraph (1), or</text></subparagraph> <subparagraph id="H9748A500C8BB4D51B54BA7CAC8BBDFBB"><enum>(B)</enum><text>the date as of which the requirements of paragraph (9) are first met.</text></subparagraph></paragraph> <paragraph id="H9ED8E7779D3F45F0BA3C48F299A29D1F"><enum>(13)</enum><header>Tolling provision</header><text>The statute of limitations for any cause of action arising under State law relating to a denial of a claim for benefits that is the subject of an action brought in Federal court under this subsection shall be tolled until such time as the Federal court makes a final disposition, including all appeals, of whether such claim should properly be within the jurisdiction of the Federal court. The tolling period shall be determined by the applicable Federal or State law, whichever period is greater.</text></paragraph> <paragraph id="H92795498F6E84021A0AB506096543219"><enum>(14)</enum><header>Purchase of insurance to cover liability</header><text>Nothing in section 410 shall be construed to preclude the purchase by a group health plan of insurance to cover any liability or losses arising under a cause of action under subsection (a)(1)(C) and this subsection.</text></paragraph> <paragraph id="H6782673E7B964709BA98B022A9F237F7"><enum>(15)</enum><header>Exclusion of directed recordkeepers</header> <subparagraph id="H2EC55EBFC02745C3BA9D629B9CAECD06"><enum>(A)</enum><header>In general</header><text>Subject to subparagraph (C), paragraph (1) shall not apply with respect to a directed recordkeeper in connection with a group health plan.</text></subparagraph> <subparagraph id="HE3897856237E4C03B932312684350000"><enum>(B)</enum><header>Directed recordkeeper</header><text>For purposes of this paragraph, the term <term>directed recordkeeper</term> means, in connection with a group health plan, a person engaged in directed recordkeeping activities pursuant to the specific instructions of the plan or the employer or other plan sponsor, including the distribution of enrollment information and distribution of disclosure materials under this Act or title I of the <short-title>Patients’ Bill of Rights Act of 2005</short-title> and whose duties do not include making decisions on claims for benefits.</text></subparagraph> <subparagraph id="H64F32958E358495F92EED9FABC4B984F"><enum>(C)</enum><header>Limitation</header><text>Subparagraph (A) does not apply in connection with any directed recordkeeper to the extent that the directed recordkeeper fails to follow the specific instruction of the plan or the employer or other plan sponsor.</text></subparagraph></paragraph> <paragraph id="H253A253B250042B39230D23B2712D3C4"><enum>(16)</enum><header>Exclusion of health insurance agents</header><text>Paragraph (1) does not apply with respect to a person whose sole involvement with the group health plan is providing advice or administrative services to the employer or other plan sponsor relating to the selection of health insurance coverage offered in connection with the plan.</text></paragraph> <paragraph id="H2AF68F7DACC54B228F8983351C49E8B2"><enum>(17)</enum><header>No effect on State law</header><text>No provision of State law (as defined in section 514(c)(1)) shall be treated as superseded or otherwise altered, amended, modified, invalidated, or impaired by reason of the provisions of subsection (a)(1)(C) and this subsection.</text></paragraph> <paragraph id="HA14DCA95527B426E8F1509DA9369EF9"><enum>(18)</enum><header>Relief from liability for employer or other plan sponsor by means of designated decisionmaker</header> <subparagraph id="H3AB9E71741B546208E00EBECC8D1797F"><enum>(A)</enum><header>In general</header><text>Notwithstanding the direct participation (as defined in paragraph (5)(C)(i)) of an employer or plan sponsor, in any case in which there is (or is deemed under subparagraph (B) to be) a designated decisionmaker under subparagraph (B) that meets the requirements of subsection (o)(1) for an employer or other plan sponsor—</text> <clause id="H61D6C1D77705440F93C855F9F3000083"><enum>(i)</enum><text>all liability of such employer or plan sponsor involved (and any employee of such employer or sponsor acting within the scope of employment) under this subsection in connection with any participant or beneficiary shall be transferred to, and assumed by, the designated decisionmaker, and</text></clause> <clause id="H41F940BBC4C140F2B659739FAF4FB4F2"><enum>(ii)</enum><text>with respect to such liability, the designated decisionmaker shall be substituted for the employer or sponsor (or employee) in the action and may not raise any defense that the employer or sponsor (or employee) could not raise if such a decisionmaker were not so deemed.</text></clause></subparagraph> <subparagraph id="H0F40F92D312F4FCEA49E2951536D5C22"><enum>(B)</enum><header>Automatic designation</header><text>A health insurance issuer shall be deemed to be a designated decisionmaker for purposes of subparagraph (A) with respect to the participants and beneficiaries of an employer or plan sponsor, whether or not the employer or plan sponsor makes such a designation, and shall be deemed to have assumed unconditionally all liability of the employer or plan sponsor under such designation in accordance with subsection (o), unless the employer or plan sponsor affirmatively enters into a contract to prevent the service of the designated decisionmaker.</text></subparagraph> <subparagraph id="H58B01473D06241BAA1DB5AA700FE78"><enum>(C)</enum><header>Treatment of certain trust funds</header><text>For purposes of this paragraph, the terms <term>employer</term> and <term>plan sponsor</term>, in connection with the assumption by a designated decisionmaker of the liability of employer or other plan sponsor pursuant to this paragraph, shall be construed to include a trust fund maintained pursuant to section 302 of the Labor Management Relations Act, 1947 (<external-xref legal-doc="usc" parsable-cite="usc/29/186">29 U.S.C. 186</external-xref>) or the Railway Labor Act (<external-xref legal-doc="usc" parsable-cite="usc/45/151">45 U.S.C. 151 et seq.</external-xref>).</text></subparagraph></paragraph> <paragraph id="H62A13A226F924DCD86FE31B9524522FC"><enum>(19)</enum><header>Previously provided services</header> <subparagraph id="H100B57008C9740529F1F005632AF4D27"><enum>(A)</enum><header>In general</header><text>Except as provided in this paragraph, a cause of action shall not arise under paragraph (1) where the denial involved relates to an item or service that has already been fully provided to the participant or beneficiary under the plan or coverage and the claim relates solely to the subsequent denial of payment for the provision of such item or service.</text></subparagraph> <subparagraph id="H6E2649414DBB4487AD9B997F70E276F6"><enum>(B)</enum><header>Exception</header><text>Nothing in subparagraph (A) shall be construed to—</text> <clause id="H8BC8C487933E4CA2A8262014EF8BDF19"><enum>(i)</enum><text>prohibit a cause of action under paragraph (1) where the nonpayment involved results in the participant or beneficiary being unable to receive further items or services that are directly related to the item or service involved in the denial referred to in subparagraph (A) or that are part of a continuing treatment or series of procedures; or</text></clause> <clause id="HB5C75715994B44DB94F8D2846046BCA4"><enum>(ii)</enum><text>limit liability that otherwise would arise from the provision of the item or services or the performance of a medical procedure.</text></clause></subparagraph></paragraph> <paragraph id="HD00EAB0EC86C41F7A8ABE71328474F3"><enum>(20)</enum><header>Exemption from personal liability for individual members of boards of directors, joint boards of trustees, etc</header><text>Any individual who is—</text> <subparagraph id="H43E3B9EA9DED4C51839409B64D26F79"><enum>(A)</enum><text>a member of a board of directors of an employer or plan sponsor; or</text></subparagraph> <subparagraph id="H500C111089D049CDBBDB513BFB38FF4C"><enum>(B)</enum><text>a member of an association, committee, employee organization, joint board of trustees, or other similar group of representatives of the entities that are the plan sponsor of plan maintained by two or more employers and one or more employee organizations;</text></subparagraph><continuation-text continuation-text-level="paragraph">shall not be personally liable under this subsection for conduct that is within the scope of employment or of plan-related duties of the individuals unless the individual acts in a fraudulent manner for personal enrichment.</continuation-text></paragraph></subsection> <subsection id="H4B7E0908BDBF478BB795C4C08F7D6953"><enum>(o)</enum><header>Requirements for designated decisionmakers of group health plans</header> <paragraph id="H5899DCBF3A4046D788EBF5F626873963"><enum>(1)</enum><header>In general</header><text>For purposes of subsection (n)(18) and section 514(d)(9), a designated decisionmaker meets the requirements of this paragraph with respect to any participant or beneficiary if—</text> <subparagraph id="HABA31C11052647ECAB4E9C8BE473DBB9"><enum>(A)</enum><text>such designation is in such form as may be prescribed in regulations of the Secretary,</text></subparagraph> <subparagraph id="H6D1304C1F8B64AC0AD29926530F63B5D"><enum>(B)</enum><text>the designated decisionmaker—</text> <clause id="H069B866D924648F5AFF4F0D8769E89F7"><enum>(i)</enum><text>meets the requirements of paragraph (2),</text></clause> <clause id="H1196E32F6E7949C987B1C7783EACAFF6"><enum>(ii)</enum><text>assumes unconditionally all liability of the employer or plan sponsor involved (and any employee of such employer or sponsor acting within the scope of employment) either arising under subsection (n) or arising in a cause of action permitted under section 514(d) in connection with actions (and failures to act) of the employer or plan sponsor (or employee) occurring during the period in which the designation under subsection (n)(18) or section 514(d)(9) is in effect relating to such participant and beneficiary,</text></clause> <clause id="H67225AABF59A410FA74DE3873915915F"><enum>(iii)</enum><text>agrees to be substituted for the employer or plan sponsor (or employee) in the action and not to raise any defense with respect to such liability that the employer or plan sponsor (or employee) may not raise, and</text></clause> <clause id="HB91F3B8AFE8B4C73B5E9C4E0F440FCF4"><enum>(iv)</enum><text>where paragraph (2)(B) applies, assumes unconditionally the exclusive authority under the group health plan to make medically reviewable decisions under the plan with respect to such participant or beneficiary, and</text></clause></subparagraph> <subparagraph id="HC6B98632D3274BFAA2A22C3BE25F02E7"><enum>(C)</enum><text>the designated decisionmaker and the participants and beneficiaries for whom the decisionmaker has assumed liability are identified in the written instrument required under section 402(a) and as required under section 121(b)(19) of the <short-title>Patients’ Bill of Rights Act of 2005</short-title>.</text></subparagraph><continuation-text continuation-text-level="paragraph">Any liability assumed by a designated decisionmaker pursuant to this subsection shall be in addition to any liability that it may otherwise have under applicable law.</continuation-text></paragraph> <paragraph id="H5D21B885D2E04F0BA0001B67844E9D3C"><enum>(2)</enum><header>Qualifications for designated decisionmakers</header> <subparagraph id="H39337921CF174209B6C9E24C455159D5"><enum>(A)</enum><header>In general</header><text>Subject to subparagraph (B), an entity is qualified under this paragraph to serve as a designated decisionmaker with respect to a group health plan if the entity has the ability to assume the liability described in paragraph (1) with respect to participants and beneficiaries under such plan, including requirements relating to the financial obligation for timely satisfying the assumed liability, and maintains with the plan sponsor and the Secretary certification of such ability. Such certification shall be provided to the plan sponsor or named fiduciary and to the Secretary upon designation under subsection (n)(18)(B) or section 517(d)(9)(B) and not less frequently than annually thereafter, or if such designation constitutes a multiyear arrangement, in conjunction with the renewal of the arrangement.</text></subparagraph> <subparagraph id="HBA4A84EFB1A4418E84D9B33819905BE4"><enum>(B)</enum><header>Special qualification in the case of certain reviewable decisions</header><text>In the case of a group health plan that provides benefits consisting of medical care to a participant or beneficiary only through health insurance coverage offered by a single health insurance issuer, such issuer is the only entity that may be qualified under this paragraph to serve as a designated decisionmaker with respect to such participant or beneficiary, and shall serve as the designated decisionmaker unless the employer or other plan sponsor acts affirmatively to prevent such service.</text></subparagraph></paragraph> <paragraph id="HEE2667AA912D490AA3BA00E2468CDDF7"><enum>(3)</enum><header>Requirements relating to financial obligations</header><text>For purposes of paragraph (2)(A), the requirements relating to the financial obligation of an entity for liability shall include—</text> <subparagraph id="H350DE2B28F5F4E4D9CF665DA64F0062"><enum>(A)</enum><text>coverage of such entity under an insurance policy or other arrangement, secured and maintained by such entity, to effectively insure such entity against losses arising from professional liability claims, including those arising from its service as a designated decisionmaker under this part; or</text></subparagraph> <subparagraph id="H0AD3BA83FCC144B196EA7D3773AA9553"><enum>(B)</enum><text>evidence of minimum capital and surplus levels that are maintained by such entity to cover any losses as a result of liability arising from its service as a designated decisionmaker under this part.</text></subparagraph><continuation-text continuation-text-level="paragraph">The appropriate amounts of liability insurance and minimum capital and surplus levels for purposes of subparagraphs (A) and (B) shall be determined by an actuary using sound actuarial principles and accounting practices pursuant to established guidelines of the American Academy of Actuaries and in accordance with such regulations as the Secretary may prescribe and shall be maintained throughout the term for which the designation is in effect. The provisions of this paragraph shall not apply in the case of a designated decisionmaker that is a group health plan, plan sponsor, or health insurance issuer and that is regulated under Federal law or a State financial solvency law.</continuation-text></paragraph> <paragraph id="HBB77953B61AF422E983511DEE59DCB9F"><enum>(4)</enum><header>Limitation on appointment of treating physicians</header><text>A treating physician who directly delivered the care, treatment, or provided the patient service that is the subject of a cause of action by a participant or beneficiary under subsection (n) or section 514(d) may not be designated as a designated decisionmaker under this subsection with respect to such participant or beneficiary.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph> <paragraph id="H1CD3B6B5A71D46F3855B88CED0B0A239"><enum>(2)</enum><header>Conforming amendment</header><text>Section 502(a)(1) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/29/1132">29 U.S.C. 1132(a)(1)</external-xref>) is amended—</text> <subparagraph id="H7DE6206E9F6344AD858DA6FAB401E100"><enum>(A)</enum><text>by striking <quote>or</quote> at the end of subparagraph (A);</text></subparagraph> <subparagraph id="H730D521CFB124F3B9FD545CECBF48E6F"><enum>(B)</enum><text>in subparagraph (B), by striking <quote>plan;</quote> and inserting <quote>plan, or</quote>; and</text></subparagraph> <subparagraph id="HB82F88E2621D42D5BF131F00B08997F4"><enum>(C)</enum><text>by adding at the end the following new subparagraph:</text> <quoted-block id="H0F7C85B5F163456EB84700276BB74C8F"> <subparagraph id="H3D0812A300CC4C9ABCF6C2BF07A20121"><enum>(C)</enum><text>for the relief provided for in subsection (n) of this section.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph></subsection> <subsection id="HCF03EC1D04BE4F1A8C1151382F34B6E3"><enum>(b)</enum><header>Rules relating to ERISA preemption</header><text>Section 514 of the <act-name parsable-cite="ERISA">Employee Retirement Income Security Act of 1974</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/29/1144">29 U.S.C. 1144</external-xref>) is amended—</text> <paragraph id="H36C5D53D751949819C3DD72E1EA1E5E1"><enum>(1)</enum><text>by redesignating subsection (d) as subsection (f); and</text></paragraph> <paragraph id="H55A1DD4A81104249893D375BD1ADF848"><enum>(2)</enum><text>by inserting after subsection (c) the following new subsections:</text> <quoted-block id="HE96CA355CD2C44A99756D536156CA706"> <subsection id="HCB06BCA94F4F4CB3A085E1C37D71BA00"><enum>(d)</enum><header>Preemption not to apply to causes of action under State law involving medically reviewable decision</header> <paragraph id="HE2F53346160844ED9F5257421786EFF"><enum>(1)</enum><header>Non-preemption of certain causes of action</header> <subparagraph id="H0A14A7B03AB640F690A3BE5CCCDFD4D"><enum>(A)</enum><header>In general</header><text>Except as provided in this subsection, nothing in this title (including section 502) shall be construed to supersede or otherwise alter, amend, modify, invalidate, or impair any cause of action under State law of a participant or beneficiary under a group health plan (or the estate of such a participant or beneficiary) against the plan, the plan sponsor, any health insurance issuer offering health insurance coverage in connection with the plan, or any managed care entity in connection with the plan to recover damages resulting from personal injury or for wrongful death if such cause of action arises by reason of a medically reviewable decision.</text></subparagraph> <subparagraph id="HDF6DBA0BC8044AB8BC52B59C83B300E"><enum>(B)</enum><header>Medically reviewable decision</header><text>For purposes of subparagraph (A), the term <term>medically reviewable decision</term> means a denial of a claim for benefits under the plan which is described in section 104(d)(2) of the <short-title>Patients’ Bill of Rights Act of 2005</short-title> (relating to medically reviewable decisions).</text></subparagraph> <subparagraph id="H7A3B388D2A064DBA8DC667CF8D2095D7"><enum>(C)</enum><header>Limitation on punitive damages</header> <clause id="H37515F0C7CEA4ECAB7A7179E91001900"><enum>(i)</enum><header>In general</header><text>Except as provided in clauses (ii) and (iii), with respect to a cause of action described in subparagraph (A) brought with respect to a participant or beneficiary, State law is superseded insofar as it provides any punitive, exemplary, or similar damages if, as of the time of the personal injury or death, all the requirements of the following sections of the <short-title>Patients’ Bill of Rights Act of 2005</short-title> were satisfied with respect to the participant or beneficiary:</text> <subclause id="HBA09CB94F5C342A380D6B6C86D00FC86"><enum>(I)</enum><text>Section 102 (relating to procedures for initial claims for benefits and prior authorization determinations).</text></subclause> <subclause id="HDC73C6059BE44E6FAEF4DC54A6D860DE"><enum>(II)</enum><text>Section 103 of such Act (relating to internal appeals of claims denials).</text></subclause> <subclause id="H9E84FD33159A42139ED078BF123B12CA"><enum>(III)</enum><text>Section 104 of such Act (relating to independent external appeals procedures).</text></subclause></clause> <clause id="H5AB06D65D8D145AE90B9ECABB4FB1B9E"><enum>(ii)</enum><header>Exception for certain actions for wrongful death</header><text>Clause (i) shall not apply with respect to an action for wrongful death if the applicable State law provides (or has been construed to provide) for damages in such an action which are only punitive or exemplary in nature.</text></clause> <clause id="H2A532D82570D4DA59F11AD8FF0252FA"><enum>(iii)</enum><header>Exception for willful or wanton disregard for the rights or safety of others</header><text>Clause (i) shall not apply with respect to any cause of action described in subparagraph (A) if, in such action, the plaintiff establishes by clear and convincing evidence that conduct carried out by the defendant with willful or wanton disregard for the rights or safety of others was a proximate cause of the personal injury or wrongful death that is the subject of the action.</text></clause></subparagraph></paragraph> <paragraph id="H44DACCE97DAE4A289248FB994618B924"><enum>(2)</enum><header>Definitions and related rules</header><text>For purposes of this subsection and subsection (e)—</text> <subparagraph id="H8B7AFBC218DA44F9A3245DD8E1F2518"><enum>(A)</enum><header>Treatment of excepted benefits</header><text>Under section 154(a) of the <short-title>Patients’ Bill of Rights Act of 2005</short-title>, the provisions of this subsection do not apply to certain excepted benefits.</text></subparagraph> <subparagraph id="H5F77C97758324D399B8CE942A0FECA75"><enum>(B)</enum><header>Personal injury</header><text>The term <term>personal injury</term> means a physical injury and includes an injury arising out of the treatment (or failure to treat) a mental illness or disease.</text></subparagraph> <subparagraph id="H76B5061C2B1B48A0BE6BE72EC5B26D00"><enum>(C)</enum><header>Claim for benefit; denial</header><text>The terms <term>claim for benefits</term> and <term>denial of a claim for benefits</term> shall have the meaning provided such terms under section 102(e) of the <short-title>Patients’ Bill of Rights Act of 2005</short-title>.</text></subparagraph> <subparagraph id="H2CE314E62A22404984C5C76E1791AA75"><enum>(D)</enum><header>Managed care entity</header> <clause id="H23D301213C1549AC9CAEBD23BC148007"><enum>(i)</enum><header>In general</header><text>The term <term>managed care entity</term> means, in connection with a group health plan and subject to clause (ii), any entity that is involved in determining the manner in which or the extent to which items or services (or reimbursement therefor) are to be provided as benefits under the plan.</text></clause> <clause id="HDD5F24FF44AE46CEB7D2D5AC05B84C67"><enum>(ii)</enum><header>Treatment of treating physicians, other treating health care professionals, and treating hospitals</header><text>Such term does not include a treating physician or other treating health care professional (as defined in section 502(n)(6)(B)(i)) of the participant or beneficiary and also does not include a treating hospital insofar as it is acting solely in the capacity of providing treatment or care to the participant or beneficiary. Nothing in the preceding sentence shall be construed to preempt vicarious liability of any plan, plan sponsor, health insurance issuer, or managed care entity.</text></clause></subparagraph></paragraph> <paragraph id="HC8F61B5468804D0186A593D728BD483C"><enum>(3)</enum><header>Exclusion of employers and other plan sponsors</header> <subparagraph id="HDB83B45E6C0C475FAAF3B6D3D04ED75"><enum>(A)</enum><header>Causes of action against employers and plan sponsors precluded</header><text>Subject to subparagraph (B), paragraph (1) does not apply with respect to—</text> <clause id="H42BFD0D1E52A4110823DE20000DACD9D"><enum>(i)</enum><text>any cause of action against an employer or other plan sponsor maintaining the plan (or against an employee of such an employer or sponsor acting within the scope of employment), or</text></clause> <clause id="H62F35F80C91043C9BF93A82EE8501561"><enum>(ii)</enum><text>a right of recovery, indemnity, or contribution by a person against an employer or other plan sponsor (or such an employee) for damages assessed against the person pursuant to a cause of action to which paragraph (1) applies.</text></clause></subparagraph> <subparagraph id="H6A6129EA73894AD096E1357EC252FF35"><enum>(B)</enum><header>Certain causes of action permitted</header><text>Notwithstanding subparagraph (A), paragraph (1) applies with respect to any cause of action that is brought by a participant or beneficiary under a group health plan (or the estate of such a participant or beneficiary) to recover damages resulting from personal injury or for wrongful death against any employer or other plan sponsor maintaining the plan (or against an employee of such an employer or sponsor acting within the scope of employment) if such cause of action arises by reason of a medically reviewable decision, to the extent that there was direct participation by the employer or other plan sponsor (or employee) in the decision.</text></subparagraph> <subparagraph id="H6E575843CF6E41B8BEA7C503472BFCE"><enum>(C)</enum><header>Direct participation</header> <clause id="H9F83DBEFE4D54C49B100C433CDF2ABB7"><enum>(i)</enum><header>Direct participation in decisions</header><text>For purposes of subparagraph (B), the term <term>direct participation</term> means, in connection with a decision described in subparagraph (B), the actual making of such decision or the actual exercise of control in making such decision or in the conduct constituting the failure.</text></clause> <clause id="HC9E4BF3DBFA54C8088491F2455CEDEB4"><enum>(ii)</enum><header>Rules of construction</header><text>For purposes of clause (i), the employer or plan sponsor (or employee) shall not be construed to be engaged in direct participation because of any form of decisionmaking or other conduct that is merely collateral or precedent to the decision described in subparagraph (B) on a particular claim for benefits of a particular participant or beneficiary, including (but not limited to)—</text> <subclause id="H3FA79C5229D54F4B9EA39BEE1B6EB677"><enum>(I)</enum><text>any participation by the employer or other plan sponsor (or employee) in the selection of the group health plan or health insurance coverage involved or the third party administrator or other agent;</text></subclause> <subclause id="H07564DEEA6E74A438554E384FE363F4C"><enum>(II)</enum><text>any engagement by the employer or other plan sponsor (or employee) in any cost-benefit analysis undertaken in connection with the selection of, or continued maintenance of, the plan or coverage involved;</text></subclause> <subclause id="HEEDFA70CAE4045768CEA081172CC84B"><enum>(III)</enum><text>any participation by the employer or other plan sponsor (or employee) in the process of creating, continuing, modifying, or terminating the plan or any benefit under the plan, if such process was not substantially focused solely on the particular situation of the participant or beneficiary referred to in paragraph (1)(A); and</text></subclause> <subclause id="H3024354C15A34486A076379B17B6B9DE"><enum>(IV)</enum><text>any participation by the employer or other plan sponsor (or employee) in the design of any benefit under the plan, including the amount of copayment and limits connected with such benefit.</text></subclause></clause> <clause id="HDC5481DC50E446588685D6BAB26C5319"><enum>(iv)</enum><header>Irrelevance of certain collateral efforts made by employer or plan sponsor</header><text>For purposes of this subparagraph, an employer or plan sponsor shall not be treated as engaged in direct participation in a decision with respect to any claim for benefits or denial thereof in the case of any particular participant or beneficiary solely by reason of—</text> <subclause id="H87D63500B7A842B3AF8C6E1F54C5C532"><enum>(I)</enum><text>any efforts that may have been made by the employer or plan sponsor to advocate for authorization of coverage for that or any other participant or beneficiary (or any group of participants or beneficiaries), or</text></subclause> <subclause id="HEF877ECC69BD428C0066111DEF4E0738"><enum>(II)</enum><text>any provision that may have been made by the employer or plan sponsor for benefits which are not covered under the terms and conditions of the plan for that or any other participant or beneficiary (or any group of participants or beneficiaries).</text></subclause></clause></subparagraph></paragraph> <paragraph id="H794F9D574B9F449B0093EA45AA9BF55B"><enum>(4)</enum><header>Requirement of exhaustion</header> <subparagraph id="HCB901AAD71B441E1B7D1E105B7B7FB2"><enum>(A)</enum><header>In general</header><text>Except as provided in subparagraph (D), paragraph (1) shall not apply in connection with any action in connection with any denial of a claim for benefits of any individual until all administrative processes under sections 102, 103, and 104 of the <short-title>Patients’ Bill of Rights Act of 2005</short-title> (if applicable) have been exhausted.</text></subparagraph> <subparagraph id="H477C8B629DF24BD98631C958C0CD16E9"><enum>(B)</enum><header>Late manifestation of injury</header> <clause id="HC9A06102E2194883BF38303D5633464E"><enum>(i)</enum><header>In general</header><text>A participant or beneficiary shall not be precluded from pursuing a review under section 104 of the <short-title>Patients’ Bill of Rights Act of 2005</short-title> regarding an injury that such participant or beneficiary has experienced if the external review entity first determines that the injury of such participant or beneficiary is a late manifestation of an earlier injury.</text></clause> <clause id="HF570BF77303044858F4F00B5DFD06BDE"><enum>(ii)</enum><header>Definition</header><text>In this subparagraph, the term <term>late manifestation of an earlier injury</term> means an injury sustained by the participant or beneficiary which was not known, and should not have been known, by such participant or beneficiary by the latest date that the requirements of subparagraph (A) should have been met regarding the claim for benefits which was denied.</text></clause></subparagraph> <subparagraph id="H818A51C9B6744712937BC256A3C5485"><enum>(C)</enum><header>Exception for needed care</header><text>A participant or beneficiary may seek relief exclusively in Federal court under subsection 502(a)(1)(B) prior to the exhaustion of administrative remedies under sections 102, 103, or 104 of the <short-title>Patients’ Bill of Rights Act of 2005</short-title> (as required under subparagraph (A)) if it is demonstrated to the court that the exhaustion of such remedies would cause irreparable harm to the health of the participant or beneficiary. Notwithstanding the awarding of relief under subsection 502(a)(1)(B) pursuant to this subparagraph, no relief shall be available as a result of, or arising under, paragraph (1)(A) unless the requirements of subparagraph (A) are met.</text></subparagraph> <subparagraph id="HF37EC2428FE74BF5BC9DC9D07D6BFA58"><enum>(D)</enum><header>Failure to review</header> <clause id="H6D578E9E51964E87A270CC46D4B227F6"><enum>(i)</enum><header>In general</header><text>If the external review entity fails to make a determination within the time required under section 104(e)(1)(A)(i) of the Patients’ Bill of Rights Act of 2005, subparagraph (A) shall not apply with respect to the action after 10 additional days after the date on which such time period has expired and the filing of such action shall not affect the duty of the independent medical reviewer (or reviewers) to make a determination pursuant to such section 104(e)(1)(A)(i).</text></clause> <clause id="H04DD76CBD9464ADDBA4E2DDB00EDD440"><enum>(ii)</enum><header>Expedited determination</header><text display-inline="yes-display-inline">If the external review entity fails to make a determination within the time required under section 104(e)(1)(A)(ii) of the Patients’ Bill of Rights Act of 2005, subparagraph (A) shall not apply with respect to the action and the filing of such an action shall not affect the duty of the independent medical reviewer (or reviewers) to make a determination pursuant to such section 104(e)(1)(A)(ii).</text></clause></subparagraph> <subparagraph id="HE6BE6668516843978BD20358998E2E51"><enum>(E)</enum><header>Receipt of benefits during appeals process</header><text>Receipt by the participant or beneficiary of the benefits involved in the claim for benefits during the pendency of any administrative processes referred to in subparagraph (A) or the pendency of any action with respect to which, under this paragraph, subparagraph (A) does not apply—</text> <clause id="H323B9AE1C3764499AB3E457ECF96C624"><enum>(i)</enum><text>shall not preclude continuation of all such administrative processes to their conclusion if so moved by any party, and</text></clause> <clause id="HFD06F9BA7A3A430483006FDFBCCAE23F"><enum>(ii)</enum><text>shall not preclude any liability under subsection (a)(1)(C) and this subsection in connection with such claim.</text></clause></subparagraph> <subparagraph id="H5D35B0CE72044F5DBB0100423B080877"><enum>(F)</enum><header>Admissible</header><text>Any determination made by a reviewer in an administrative proceeding under section 104 of the <short-title>Patients’ Bill of Rights Act of 2005</short-title> shall be admissible in any Federal or State court proceeding and shall be presented to the trier of fact.</text></subparagraph></paragraph> <paragraph id="H177BC8737E6340E6A5B33307B38797CE"><enum>(5)</enum><header>Tolling provision</header><text>The statute of limitations for any cause of action arising under section 502(n) relating to a denial of a claim for benefits that is the subject of an action brought in State court shall be tolled until such time as the State court makes a final disposition, including all appeals, of whether such claim should properly be within the jurisdiction of the State court. The tolling period shall be determined by the applicable Federal or State law, whichever period is greater.</text></paragraph> <paragraph id="H21B12C7E69344B0F00EAAD3D82049E95"><enum>(6)</enum><header>Exclusion of directed recordkeepers</header> <subparagraph id="H93F6A6BAE640492E8700AE28CD5D9394"><enum>(A)</enum><header>In general</header><text>Subject to subparagraph (C), paragraph (1) shall not apply with respect to any action against a directed recordkeeper in connection with a group health plan.</text></subparagraph> <subparagraph id="H66C692B2F33647D1A786008C6020FBFF"><enum>(B)</enum><header>Directed recordkeeper</header><text>For purposes of this paragraph, the term <term>directed recordkeeper</term> means, in connection with a group health plan, a person engaged in directed recordkeeping activities pursuant to the specific instructions of the plan or the employer or other plan sponsor, including the distribution of enrollment information and distribution of disclosure materials under this Act or title I of the <short-title>Patients’ Bill of Rights Act of 2005</short-title> and whose duties do not include making decisions on claims for benefits.</text></subparagraph> <subparagraph id="HD2603BB0CDE247A79E045162CE3853D4"><enum>(C)</enum><header>Limitation</header><text>Subparagraph (A) does not apply in connection with any directed recordkeeper to the extent that the directed recordkeeper fails to follow the specific instruction of the plan or the employer or other plan sponsor.</text></subparagraph></paragraph> <paragraph id="HCECBA02A50AA43E986CA3C7F27543FAC"><enum>(7)</enum><header>Construction</header><text>Nothing in this subsection shall be construed as—</text> <subparagraph id="HAD53F100F7344B2EA2D7E05EEE9507C5"><enum>(A)</enum><text>saving from preemption a cause of action under State law for the failure to provide a benefit for an item or service which is specifically excluded under the group health plan involved, except to the extent that—</text> <clause id="H19203578B545492DA7FB68FEC73DA161"><enum>(i)</enum><text>the application or interpretation of the exclusion involves a determination described in section 104(d)(2) of the <short-title>Patients’ Bill of Rights Act of 2005</short-title>, or</text></clause> <clause id="H0DDC45C8B1264508B6175100EC954498"><enum>(ii)</enum><text>the provision of the benefit for the item or service is required under Federal law or under applicable State law consistent with subsection (b)(2)(B);</text></clause></subparagraph> <subparagraph id="HEC7EAF6834DF4A25AAC4172BCD1653D8"><enum>(B)</enum><text>preempting a State law which requires an affidavit or certificate of merit in a civil action;</text></subparagraph> <subparagraph id="H0CDA690E358F4C9880E81FA7CFFC3D16"><enum>(C)</enum><text>affecting a cause of action or remedy under State law in connection with the provision or arrangement of excepted benefits (as defined in section 733(c)), other than those described in section 733(c)(2)(A); or</text></subparagraph> <subparagraph id="HC0741989BAF84D73B0C81B38232CB25C"><enum>(D)</enum><text>affecting a cause of action under State law other than a cause of action described in paragraph (1)(A).</text></subparagraph></paragraph> <paragraph id="H19DE367626EF440795916784D8AE3D00"><enum>(8)</enum><header>Purchase of insurance to cover liability</header><text>Nothing in section 410 shall be construed to preclude the purchase by a group health plan of insurance to cover any liability or losses arising under a cause of action described in paragraph (1)(A).</text></paragraph> <paragraph id="HAA456F78F2E04FE3B1BABEBB27691FDC"><enum>(9)</enum><header>Relief from liability for employer or other plan sponsor by means of designated decisionmaker</header> <subparagraph id="H84927FF479604997AF72293176AD80D8"><enum>(A)</enum><header>In general</header><text>Paragraph (1) shall not apply with respect to any cause of action described in paragraph (1)(A) under State law insofar as such cause of action provides for liability with respect to a participant or beneficiary of an employer or plan sponsor (or an employee of such employer or sponsor acting within the scope of employment), if with respect to the employer or plan sponsor there is (or is deemed under subparagraph (B) to be) a designated decisionmaker that meets the requirements of section 502(o)(1) with respect to such participant or beneficiary. Such paragraph (1) shall apply with respect to any cause of action described in paragraph (1)(A) under State law against the designated decisionmaker of such employer or other plan sponsor with respect to the participant or beneficiary.</text></subparagraph> <subparagraph id="HCCD70D5E81D54172B1416061762BF28C"><enum>(B)</enum><header>Automatic designation</header><text>A health insurance issuer shall be deemed to be a designated decisionmaker for purposes of subparagraph (A) with respect to the participants and beneficiaries of an employer or plan sponsor, whether or not the employer or plan sponsor makes such a designation, and shall be deemed to have assumed unconditionally all liability of the employer or plan sponsor under such designation in accordance with subsection (o), unless the employer or plan sponsor affirmatively enters into a contract to prevent the service of the designated decisionmaker.</text></subparagraph> <subparagraph id="HB4B25EC69D474993B56EAD79671E3C7"><enum>(C)</enum><header>Treatment of certain trust funds</header><text>For purposes of this paragraph, the terms <term>employer</term> and <term>plan sponsor</term>, in connection with the assumption by a designated decisionmaker of the liability of employer or other plan sponsor pursuant to this paragraph, shall be construed to include a trust fund maintained pursuant to section 302 of the Labor Management Relations Act, 1947 (<external-xref legal-doc="usc" parsable-cite="usc/29/186">29 U.S.C. 186</external-xref>) or the Railway Labor Act (<external-xref legal-doc="usc" parsable-cite="usc/45/151">45 U.S.C. 151 et seq.</external-xref>).</text></subparagraph></paragraph> <paragraph id="H3F323DBB553C4A62AB8B7B5B716F2990"><enum>(10)</enum><header>Previously provided services</header> <subparagraph id="HE8FDD853CF5E40A1A68F863692AB92A4"><enum>(A)</enum><header>In general</header><text>Except as provided in this paragraph, paragraph (1) shall not apply with respect to a cause of action where the denial involved relates to an item or service that has already been fully provided to the participant or beneficiary under the plan or coverage and the claim relates solely to the subsequent denial of payment for the provision of such item or service.</text></subparagraph> <subparagraph id="H685FC8F89E7E46FEAC703564E236C400"><enum>(B)</enum><header>Exception</header><text>Nothing in subparagraph (A) shall be construed to—</text> <clause id="HE504A77665254BCEBDC3ACAD3F9CBC46"><enum>(i)</enum><text>exclude a cause of action from exemption under paragraph (1) where the nonpayment involved results in the participant or beneficiary being unable to receive further items or services that are directly related to the item or service involved in the denial referred to in subparagraph (A) or that are part of a continuing treatment or series of procedures;</text></clause> <clause id="H5EF89E2ED3584DFDB882D266235E7058"><enum>(ii)</enum><text display-inline="yes-display-inline">exclude a cause of action from exemption under paragraph (1) relating to quality of care; or</text></clause> <clause id="HCC20207497284C119D72BC477E54CF96"><enum>(iii)</enum><text>limit liability that otherwise would arise from the provision of the item or services or the performance of a medical procedure.</text></clause></subparagraph></paragraph> <paragraph id="HE08842C177DD43828300086CF5D89F32"><enum>(11)</enum><header>Exemption from personal liability for individual members of boards of directors, joint boards of trustees, etc</header><text>Any individual who is—</text> <subparagraph id="HEA79D6372E4442ECBFAB29CF30DF1F81"><enum>(A)</enum><text>a member of a board of directors of an employer or plan sponsor; or</text></subparagraph> <subparagraph id="H0FDDB158EE9F4AAEBECF49D70731064C"><enum>(B)</enum><text>a member of an association, committee, employee organization, joint board of trustees, or other similar group of representatives of the entities that are the plan sponsor of plan maintained by two or more employers and one or more employee organizations;</text></subparagraph><continuation-text continuation-text-level="paragraph">shall not be personally liable, by reason of the exemption of a cause of action from preemption under this subsection, for conduct that is within the scope of employment or of plan-related duties of the individuals unless the individual acts in a fraudulent manner for personal enrichment.</continuation-text></paragraph> <paragraph id="H2B23815AEAA044D4A8313887F96EAA88"><enum>(12)</enum><header>Choice of law</header><text>A cause of action exempted from preemption under paragraph (1) shall be governed by the law (including choice of law rules) of the State in which the plaintiff resides.</text></paragraph> <paragraph id="H9DCF5A2EAE7743529CD9068F0000C293"><enum>(13)</enum><header>Limitation on attorneys’ fees</header> <subparagraph id="H2C8F687CD6A141E2932270FEEE7500FE"><enum>(A)</enum><header>In general</header><text>Notwithstanding any other provision of law, or any arrangement, agreement, or contract regarding an attorney’s fee, the amount of an attorney’s contingency fee allowable for a cause of action exemption from preemption under paragraph (1) shall not exceed <fraction>1/3</fraction> of the total amount of the plaintiff’s recovery (not including the reimbursement of actual out-of-pocket expenses of the attorney).</text></subparagraph> <subparagraph id="H56F33F92B9484B8E903F11F4B782B951"><enum>(B)</enum><header>Determination by court</header><text>The last court in which the action was pending upon the final disposition, including all appeals, of the action may review the attorney’s fee to ensure that the fee is a reasonable one.</text></subparagraph> <subparagraph id="H4443F7EB4ADB41A5BAF17136397EABB0"><enum>(C)</enum><header>No preemption of State law</header><text>Subparagraph (A) shall not apply with respect to a cause of action that is brought in a State that has a law or framework of laws with respect to the amount of an attorney’s contingency fee that may be incurred for the representation of a participant or beneficiary (or the estate of such participant or beneficiary) who brings such a cause of action.</text></subparagraph></paragraph></subsection> <subsection id="H27D3A5CD5693449FB873E5BA342025E"><enum>(e)</enum><header>Rules of construction relating to health care</header><text>Nothing in this title shall be construed as—</text> <paragraph id="HBDB342813F444EEF86CB3303DF3D9199"><enum>(1)</enum><text>affecting any State law relating to the practice of medicine or the provision of, or the failure to provide, medical care, or affecting any action (whether the liability is direct or vicarious) based upon such a State law,</text></paragraph> <paragraph id="HC7F5CA7F6B7D4745AB61B2D740E6F426"><enum>(2)</enum><text>superseding any State law permitted under section 152(b)(1)(A) of the <short-title>Patients’ Bill of Rights Act of 2005</short-title>, or</text></paragraph> <paragraph id="H0FDD18B1F6454DDC9DB2A0DB1B009B00"><enum>(3)</enum><text>affecting any applicable State law with respect to limitations on monetary damages.</text></paragraph></subsection> <subsection id="H29A5611318D7421AB85925F85BC42FE4"><enum>(f)</enum><header>No right of action for recovery, indemnity, or contribution by issuers against treating health care professionals and treating hospitals</header><text>In the case of any care provided, or any treatment decision made, by the treating health care professional or the treating hospital of a participant or beneficiary under a group health plan which consists of medical care provided under such plan, any cause of action under State law against the treating health care professional or the treating hospital by the plan or a health insurance issuer providing health insurance coverage in connection with the plan for recovery, indemnity, or contribution in connection with such care (or any medically reviewable decision made in connection with such care) or such treatment decision is superseded.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection> <subsection id="HEA40ECB2146345A2AFCC577303DE1CCE"><enum>(c)</enum><header>Effective date</header><text>The amendments made by this section shall apply to acts and omissions (from which a cause of action arises) occurring on or after the applicable effective date under section 601.</text></subsection></section> <section id="H229B9DDDBF27479BB2AEC6CDC8CE4B83"><enum>403.</enum><header>Cooperation between Federal and State authorities</header> <subsection id="H9FFF9B94B17649E399DE4FB8AEF92100"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Subpart C of part 7 of subtitle B of title I of the <act-name parsable-cite="ERISA">Employee Retirement Income Security Act of 1974</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/29/1191">29 U.S.C. 1191 et seq.</external-xref>) is amended by adding at the end the following new section:</text> <quoted-block act-name="Employee Retirement Income Security Act of 1974" id="HB722603CC9DA4227B3E0F73835ADA345"> <section id="H81B12AA0FADA41F0BF8E59DE38231657"><enum>735.</enum><header>Cooperation between Federal and State authorities</header> <subsection id="H29030BA456744AEF8201775DC8FCB600"><enum>(a)</enum><header>Agreement with States</header><text>A State may enter into an agreement with the Secretary for the delegation to the State of some or all of the Secretary’s authority under this title to enforce the requirements applicable under title I of the <short-title>Patients’ Bill of Rights Act of 2005</short-title> with respect to health insurance coverage offered by a health insurance issuer and with respect to a group health plan that is a non-Federal governmental plan.</text></subsection> <subsection id="HD050674F697142D1A0115500650842DC"><enum>(b)</enum><header>Delegations</header><text>Any department, agency, or instrumentality of a State to which authority is delegated pursuant to an agreement entered into under this section may, if authorized under State law and to the extent consistent with such agreement, exercise the powers of the Secretary under this title which relate to such authority.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="H8447487BDBB64D95AA490701C1E97D23"><enum>(b)</enum><header>Clerical amendment</header><text>The table of contents of such Act is amended by inserting after the item relating to section 734 the following new item:</text> <quoted-block style="OLC" id="HFEDD666CE8DE4962ACCEBE838DB0F93F" display-inline="no-display-inline"> <toc regeneration="no-regeneration"> <toc-entry level="section">Sec. 735. Cooperation between Federal and State authorities</toc-entry></toc><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section> <enum>V</enum><header>Amendments to the Internal Revenue Code of 1986</header> <subtitle id="H1D70C16C84DB4021A97DF5B0A52C6C29"><enum>A</enum><header>Application of patient protection provisions</header> <section id="HD58BBC4CD33C4B5692957ECBC8B16BA"><enum>501.</enum><header>Application to group health plans under the Internal Revenue Code of 1986</header><text display-inline="no-display-inline">Subchapter B of <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/26/100">chapter 100</external-xref> of the Internal Revenue Code of 1986 is amended—</text> <paragraph id="H355556C602694EFCAED561EDFB7794F1"><enum>(1)</enum><text>in the table of sections, by inserting after the item relating to section 9812 the following new item:</text> <quoted-block style="OLC" id="H6B23C70554B2450E00B5CF37E62D737" display-inline="no-display-inline"> <toc container-level="quoted-block-container" quoted-block="no-quoted-block" lowest-level="section" idref="HEA51AE624A7C460FB5F5554286C69D60" regeneration="yes-regeneration" lowest-bolded-level="division-lowest-bolded"> <toc-entry idref="HFF6103FF2F7048519D248FC3422F277C" level="section">Sec. 9813. Standard relating to patients’ bill of rights</toc-entry></toc><after-quoted-block>; and</after-quoted-block></quoted-block> </paragraph> <paragraph id="H5E42889790DE4222A93EF400C7062BD3"><enum>(2)</enum><text>by inserting after section 9812 the following:</text> <quoted-block id="HEA51AE624A7C460FB5F5554286C69D60"> <section id="HFF6103FF2F7048519D248FC3422F277C"><enum>9813.</enum><header>Standard relating to patients’ bill of rights</header><text display-inline="no-display-inline">A group health plan shall comply with the requirements of title I of the <short-title>Patients’ Bill of Rights Act of 2005</short-title> (as in effect as of the date of the enactment of such Act), and such requirements shall be deemed to be incorporated into this section.</text></section><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section> <section id="H76E8DCC41BF84B97B0C500007BF3533"><enum>502.</enum><header>Conforming enforcement for women’s health and cancer rights</header><text display-inline="no-display-inline">Subchapter B of <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/26/100">chapter 100</external-xref> of the Internal Revenue Code of 1986, as amended by section 501, is further amended—</text> <paragraph id="HA5C86620BEC646B3B4B8713F77A12FAB"><enum>(1)</enum><text>in the table of sections, by inserting after the item relating to section 9813 the following new item:</text> <quoted-block style="OLC" id="HD996DA7BAAB44B3EA35E25A8369BB88" display-inline="no-display-inline"> <toc container-level="quoted-block-container" quoted-block="no-quoted-block" lowest-level="section" idref="H336406856233486DA4C81B6C90C6E75C" regeneration="yes-regeneration" lowest-bolded-level="division-lowest-bolded"> <toc-entry idref="H03A9E37C89AA43438B514B2B6FF20042" level="section">Sec. 9814. Standard relating to women’s health and cancer rights</toc-entry></toc><after-quoted-block>; and</after-quoted-block></quoted-block> </paragraph> <paragraph id="HFE82E12F8CC646BA808F8677FA6ED088"><enum>(2)</enum><text>by inserting after section 9813 the following:</text> <quoted-block id="H336406856233486DA4C81B6C90C6E75C"> <section id="H03A9E37C89AA43438B514B2B6FF20042"><enum>9814.</enum><header>Standard relating to women’s health and cancer rights</header><text display-inline="no-display-inline">The provisions of section 713 of the <act-name parsable-cite="ERISA">Employee Retirement Income Security Act of 1974</act-name> (as in effect as of the date of the enactment of this section) shall apply to group health plans as if included in this subchapter.</text></section><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section></subtitle> <subtitle id="H273738E382854EAF9ED5CDE94AAC800"><enum>B</enum><header>Health care coverage access tax incentives</header> <section id="H08A35BC677C542A69E817285A057746B"><enum>511.</enum><header>Credit for health insurance expenses of small businesses</header> <subsection id="HC0D95C18C19941F5990057CF5C444DA2"><enum>(a)</enum><header>In general</header><text>Subpart D of part IV of subchapter A of <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/26/1">chapter 1</external-xref> of the Internal Revenue Code of 1986 (relating to business-related credits) is amended by adding at the end the following:</text> <quoted-block id="HA7F8595AA23F4D6B9C64BCFFBA00F8E6"> <section id="HE6BE77D697A24878B692E282FE35C7B3"><enum>45J.</enum><header>Small business health insurance expenses</header> <subsection id="H41DD45E26D8849EB9EE4ECECBD385137"><enum>(a)</enum><header>General rule</header><text>For purposes of section 38, in the case of a small employer, the health insurance credit determined under this section for the taxable year is an amount equal to the applicable percentage of the expenses paid by the taxpayer during the taxable year for health insurance coverage for such year provided under a new health plan for employees of such employer.</text></subsection> <subsection id="H2DB4A856ADF84EFA84DF779D71EB6EFF"><enum>(b)</enum><header>Applicable percentage</header><text>For purposes of subsection (a), the applicable percentage is—</text> <paragraph id="HBCAA2EF5150844FEAD228D82B05B4358"><enum>(1)</enum><text>in the case of insurance purchased as a member of a qualified health benefit purchasing coalition (as defined in section 9841), 30 percent, and</text></paragraph> <paragraph id="H38B527C732C44D768CD1787FBC563EA"><enum>(2)</enum><text>in the case of insurance not described in paragraph (1), 20 percent.</text></paragraph></subsection> <subsection id="H45C478D6D5D24C22AF7297009D44ED5E"><enum>(c)</enum><header>Limitations</header> <paragraph id="H49F3D1E946774A3BAA8582BD472600D8"><enum>(1)</enum><header>Per employee dollar limitation</header><text>The amount of expenses taken into account under subsection (a) with respect to any employee for any taxable year shall not exceed—</text> <subparagraph id="HCB9E414638D247C0007227CEFA38C9C6"><enum>(A)</enum><text>$2,000 in the case of self-only coverage, and</text></subparagraph> <subparagraph id="HA62780C09D63481598A21B085967866B"><enum>(B)</enum><text>$5,000 in the case of family coverage.</text></subparagraph><continuation-text continuation-text-level="paragraph">In the case of an employee who is covered by a new health plan of the employer for only a portion of such taxable year, the limitation under the preceding sentence shall be an amount which bears the same ratio to such limitation (determined without regard to this sentence) as such portion bears to the entire taxable year.</continuation-text></paragraph> <paragraph id="H3662E42B3D9A440AA7EA04344DED655C"><enum>(2)</enum><header>Period of coverage</header><text>Expenses may be taken into account under subsection (a) only with respect to coverage for the 4-year period beginning on the date the employer establishes a new health plan.</text></paragraph></subsection> <subsection id="HD7E1EEE9AD5C41BBBA308BBAFD5E3800"><enum>(d)</enum><header>Definitions</header><text>For purposes of this section—</text> <paragraph id="HA24FE17B2A7F46E0856D9E6C12C9382E"><enum>(1)</enum><header>Health insurance coverage</header><text>The term <term>health insurance coverage</term> has the meaning given such term by section 9832(b)(1).</text></paragraph> <paragraph id="HB38E339E62534DD290908715FE50CD61"><enum>(2)</enum><header>New health plan</header> <subparagraph id="H6B18B06510AC48B49D500953AEF5E1D6"><enum>(A)</enum><header>In general</header><text>The term <term>new health plan</term> means any arrangement of the employer which provides health insurance coverage to employees if—</text> <clause id="H2F8DBE8D80EB4BF48F974E11745E7874"><enum>(i)</enum><text>such employer (and any predecessor employer) did not establish or maintain such arrangement (or any similar arrangement) at any time during the 2 taxable years ending prior to the taxable year in which the credit under this section is first allowed, and</text></clause> <clause id="HBDFEC8E347214FCEB5EE85403FB64B05"><enum>(ii)</enum><text>such arrangement provides health insurance coverage to at least 70 percent of the qualified employees of such employer.</text></clause></subparagraph> <subparagraph id="HDC56927E48284C658496DD0092811EB5"><enum>(B)</enum><header>Qualified employee</header> <clause id="H0A45FFC56D20416D85599F08FD3D844E"><enum>(i)</enum><header>In general</header><text>The term <term>qualified employee</term> means any employee of an employer if the annual rate of such employee’s compensation (as defined in section 414(s)) exceeds $10,000.</text></clause> <clause id="H8872D66C6509403DA471AE10891EA360"><enum>(ii)</enum><header>Treatment of certain employees</header><text>The term <term>employee</term> shall include a leased employee within the meaning of section 414(n).</text></clause></subparagraph></paragraph> <paragraph id="H314B311D97F34F6C86264F29913B52F2"><enum>(3)</enum><header>Small employer</header><text>The term <term>small employer</term> has the meaning given to such term by section 4980D(d)(2); except that only qualified employees shall be taken into account.</text></paragraph></subsection> <subsection id="H66341A38E2664D89A687480008FEFF6"><enum>(e)</enum><header>Special rules</header> <paragraph id="H780A7E2628E74806B50328009C948EF9"><enum>(1)</enum><header>Certain rules made applicable</header><text>For purposes of this section, rules similar to the rules of section 52 shall apply.</text></paragraph> <paragraph id="H2341C575A61C47BBBE1FBF001D1D92D8"><enum>(2)</enum><header>Amounts paid under salary reduction arrangements</header><text>No amount paid or incurred pursuant to a salary reduction arrangement shall be taken into account under subsection (a).</text></paragraph></subsection> <subsection id="H6CF6E2084B1C4BEAAA31943B07722167"><enum>(f)</enum><header>Termination</header><text>This section shall not apply to expenses paid or incurred by an employer with respect to any arrangement established on or after January 1, 2014.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="HAF5DFB444A0349CEB43425D0871F1FDA"><enum>(b)</enum><header>Credit to be part of general business credit</header><text>Section 38(b) of such Code (relating to current year business credit) is amended by striking <quote>plus</quote> at the end of paragraph (18), by striking the period at the end of paragraph (19) and inserting <quote>, plus</quote>, and by adding at the end the following:</text> <quoted-block id="H50A6C38112ED4D64BF00D996F668EA54"> <paragraph id="HA23FDDA8D53F49D89EBE55E0F949FEF5"><enum>(20)</enum><text>in the case of a small employer (as defined in section 45J(d)(3)), the health insurance credit determined under section 45J(a).</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="H881D2C1F2A4F406CB75B23C3E2C161FC"><enum>(c)</enum><header>Denial of double benefit</header><text>Section 280C of such Code is amended by adding at the end the following new subsection:</text> <quoted-block id="H0FCE166BCBF647AABA85C77D2B55DA7"> <subsection id="H2C2AB8EE8CDF4501A93E46A0F5FAF518"><enum>(e)</enum><header>Credit for small business health insurance expenses</header> <paragraph id="H33957F9F568F4E6D91A08C23C18C00A9"><enum>(1)</enum><header>In general</header><text>No deduction shall be allowed for that portion of the expenses (otherwise allowable as a deduction) taken into account in determining the credit under section 45J for the taxable year which is equal to the amount of the credit determined for such taxable year under section 45J(a).</text></paragraph> <paragraph id="H312FF8ECD1FC4475AA113BBF4816D4A8"><enum>(2)</enum><header>Controlled groups</header><text>Persons treated as a single employer under subsection (a) or (b) of section 52 shall be treated as 1 person for purposes of this section.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="H6139B0190D8E4DFE9488648D2C7BDF5C"><enum>(d)</enum><header>Clerical amendment</header><text>The table of sections for subpart D of part IV of subchapter A of chapter 1 of such Code is amended by adding at the end the following:</text> <quoted-block style="OLC" id="H33C599DA44C74ABAB4B9E60082EF1546" display-inline="no-display-inline"> <toc container-level="quoted-block-container" quoted-block="no-quoted-block" lowest-level="section" idref="HA7F8595AA23F4D6B9C64BCFFBA00F8E6" regeneration="yes-regeneration" lowest-bolded-level="division-lowest-bolded"> <toc-entry idref="HE6BE77D697A24878B692E282FE35C7B3" level="section">Sec. 45J. Small business health insurance expenses</toc-entry></toc><after-quoted-block>.</after-quoted-block></quoted-block> </subsection> <subsection id="HB77AA6E79E4B4C6592AD5E0029009C55"><enum>(e)</enum><header>Effective date</header><text>The amendments made by this section shall apply to amounts paid or incurred in taxable years beginning after December 31, 2006, for arrangements established after the date of the enactment of this Act.</text></subsection></section> <section id="H94321D0C485845F9A30087A3ED62679"><enum>512.</enum><header>Certain grants by private foundations to qualified health benefit purchasing coalitions</header> <subsection id="H057C5AB694DD4ECCA4F288A2D2ED17F"><enum>(a)</enum><header>In general</header><text><external-xref legal-doc="usc" parsable-cite="usc/26/4942">Section 4942</external-xref> of the Internal Revenue Code of 1986 (relating to taxes on failure to distribute income) is amended by adding at the end the following:</text> <quoted-block id="H5742D940FAB14917BFEF8BC8D23C5F3B"> <subsection id="H65C10ED63A5C411E878F33A36351DEC5"><enum>(k)</enum><header>Certain qualified health benefit purchasing coalition distributions</header> <paragraph id="H8E6BBE7522F344028647709631D7B4B5"><enum>(1)</enum><header>In general</header><text>For purposes of subsection (g), sections 170, 501, 507, 509, and 2522, and this chapter, a qualified health benefit purchasing coalition distribution by a private foundation shall be considered to be a distribution for a charitable purpose.</text></paragraph> <paragraph id="HA0C52CC04C0D43028CD23BC9D9B311FA"><enum>(2)</enum><header>Qualified health benefit purchasing coalition distribution</header><text>For purposes of paragraph (1)—</text> <subparagraph id="H9D9F1EF855CF40C89F3F049564DFEF09"><enum>(A)</enum><header>In general</header><text>The term <term>qualified health benefit purchasing coalition distribution</term> means any amount paid or incurred by a private foundation to or on behalf of a qualified health benefit purchasing coalition (as defined in section 9841) for purposes of payment or reimbursement of amounts paid or incurred in connection with the establishment and maintenance of such coalition.</text></subparagraph> <subparagraph id="HF03FDF3265484EE5B5D42E2905317D45"><enum>(B)</enum><header>Exclusions</header><text>Such term shall not include any amount used by a qualified health benefit purchasing coalition (as so defined)—</text> <clause id="H2593EEE0B5D04AF49C155624DC7239D2"><enum>(i)</enum><text>for the purchase of real property,</text></clause> <clause id="HEF236A73E7F74399B76CA45BE4E68346"><enum>(ii)</enum><text>as payment to, or for the benefit of, members (or employees or affiliates of such members) of such coalition, or</text></clause> <clause id="H3F902892EB1A489BB4B55621FE925D7C"><enum>(iii)</enum><text>for any expense paid or incurred more than 48 months after the date of establishment of such coalition.</text></clause></subparagraph></paragraph> <paragraph id="HB9295B65E93D49CF93D8E1352BEDCDC"><enum>(3)</enum><header>Termination</header><text>This subsection shall not apply—</text> <subparagraph id="H771B7DBDBCA24C618DB7D212B8BEFA"><enum>(A)</enum><text>to qualified health benefit purchasing coalition distributions paid or incurred after December 31, 2013, and</text></subparagraph> <subparagraph id="H861FF64F90544D5685B2AF0087BE73BB"><enum>(B)</enum><text>with respect to start-up costs of a coalition which are paid or incurred after December 31, 2014.</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="H582AD39A773C40DEB8CB0473D2E44412"><enum>(b)</enum><header>Qualified health benefit purchasing coalition</header> <paragraph id="HA3DD4DEBE1E445D69957BFA86C00F5E8"><enum>(1)</enum><header>In general</header><text>Chapter 100 of such Code (relating to group health plan requirements) is amended by adding at the end the following new subchapter:</text> <quoted-block id="H4DCDD58B0A564257B1C900F500894CD3"> <subchapter id="H6DB9A87328ED442FADF4D7067500E5ED"><enum>D</enum><header>Qualified health benefit purchasing coalition</header> <toc regeneration="no-regeneration"> <toc-entry level="section">Sec. 9841. Qualified health benefit purchasing coalition</toc-entry></toc> <section id="H6A22DA46A5124C558BD1FA89662021B1"><enum>9841.</enum><header>Qualified health benefit purchasing coalition</header> <subsection id="H0E0234B20D7B4C6FA4CE8B78CA92ABDD"><enum>(a)</enum><header>In general</header><text>A qualified health benefit purchasing coalition is a private not-for-profit corporation which—</text> <paragraph id="H65891FC1BAF54D4AAA033D642338AB50"><enum>(1)</enum><text>sells health insurance through State licensed health insurance issuers in the State in which the employers to which such coalition is providing insurance are located, and</text></paragraph> <paragraph id="HFC72222189B04D7D84F288B578661C6E"><enum>(2)</enum><text>establishes to the Secretary, under State certification procedures or other procedures as the Secretary may provide by regulation, that such coalition meets the requirements of this section.</text></paragraph></subsection> <subsection id="H0094549A2F6B423C952B197D93B139FE"><enum>(b)</enum><header>Board of Directors</header> <paragraph id="HED199BAE9F73400BABA744BE9FBE5109"><enum>(1)</enum><header>In general</header><text>Each purchasing coalition under this section shall be governed by a Board of Directors.</text></paragraph> <paragraph id="H0B0E526E24344E58B5117FF9DE00D4F1"><enum>(2)</enum><header>Election</header><text>The Secretary shall establish procedures governing election of such Board.</text></paragraph> <paragraph id="HE72A23B273C340ECBB55CF901754166E"><enum>(3)</enum><header>Membership</header><text>The Board of Directors shall—</text> <subparagraph id="H06F6CB7014E94426BF01E14436717EB2"><enum>(A)</enum><text>be composed of representatives of the members of the coalition, in equal number, including small employers and employee representatives of such employers, but</text></subparagraph> <subparagraph id="HAA0A56DB390B4549BC53E9FC7344A7F"><enum>(B)</enum><text>not include other interested parties, such as service providers, health insurers, or insurance agents or brokers which may have a conflict of interest with the purposes of the coalition.</text></subparagraph></paragraph></subsection> <subsection id="HEF46644A0D224223AEB0BBBB49AB2053"><enum>(c)</enum><header>Membership of coalition</header> <paragraph id="HB95C0249407B4B9384005E60BEAA12DA"><enum>(1)</enum><header>In general</header><text>A purchasing coalition shall accept all small employers residing within the area served by the coalition as members if such employers request such membership.</text></paragraph> <paragraph id="H6FB799D22AFF48B796C38923CA42711"><enum>(2)</enum><header>Other members</header><text>The coalition, at the discretion of its Board of Directors, may be open to individuals and large employers.</text></paragraph> <paragraph id="HC9B2A9FD7EC5409091EAD1ABCE9A12C"><enum>(3)</enum><header>Voting</header><text>Members of a purchasing coalition shall have voting rights consistent with the rules established by the State.</text></paragraph></subsection> <subsection id="H4BB89F1243704CA19DF9B7AC34009200"><enum>(d)</enum><header>Duties of purchasing coalitions</header><text>Each purchasing coalition shall—</text> <paragraph id="H546BCFD86F1441D9A3D971E60041E308"><enum>(1)</enum><text>enter into agreements with small employers (and, at the discretion of its Board, with individuals and other employers) to provide health insurance benefits to employees and retirees of such employers,</text></paragraph> <paragraph id="H4013312154994621BCD547C1C24DE628"><enum>(2)</enum><text>where feasible, enter into agreements with 3 or more unaffiliated, qualified licensed health plans, to offer benefits to members,</text></paragraph> <paragraph id="H70471FC129BB42E0841BB836AC615C30"><enum>(3)</enum><text>offer to members at least 1 open enrollment period of at least 30 days per calendar year,</text></paragraph> <paragraph id="H9FD6B726A773404A9BA18A1DA22044C"><enum>(4)</enum><text>serve a significant geographical area and market to all eligible members in that area, and</text></paragraph> <paragraph id="H874D5987709D4CCC969000F90039B7E0"><enum>(5)</enum><text>carry out other functions provided for under this section.</text></paragraph></subsection> <subsection id="H695E7DB42BDA47808CF04555F11B0434"><enum>(e)</enum><header>Limitation on activities</header><text>A purchasing coalition shall not—</text> <paragraph id="H7E7394A051F14A3696A72607BAB83F3B"><enum>(1)</enum><text>perform any activity (including certification or enforcement) relating to compliance or licensing of health plans,</text></paragraph> <paragraph id="H313D8D88B88646FEB2D8837DD26B1B91"><enum>(2)</enum><text>assume insurance or financial risk in relation to any health plan, or</text></paragraph> <paragraph id="HC3A60AE135764B54B0876E0545D3A41E"><enum>(3)</enum><text>perform other activities identified by the State as being inconsistent with the performance of its duties under this section.</text></paragraph></subsection> <subsection id="H92167BD22CC54F41B5006D5C721FCA9F"><enum>(f)</enum><header>Additional requirements for purchasing coalitions</header><text>As provided by the Secretary in regulations, a purchasing coalition shall be subject to requirements similar to the requirements of a group health plan under this chapter.</text></subsection> <subsection id="HF839B907ABE24FDD94FD5C33BA1FC019"><enum>(g)</enum><header>Relation to other laws</header> <paragraph id="H4481BB027D5447EBA704FA184F06F027"><enum>(1)</enum><header>Preemption of State fictitious group laws</header><text>Requirements (commonly referred to as fictitious group laws) relating to grouping and similar requirements for health insurance coverage are preempted to the extent such requirements impede the establishment and operation of qualified health benefit purchasing coalitions.</text></paragraph> <paragraph id="HF49165A9B7704681A425F1868FC100EA"><enum>(2)</enum><header>Allowing savings to be passed through</header><text>Any State law that prohibits health insurance issuers from reducing premiums on health insurance coverage sold through a qualified health benefit purchasing coalition to reflect administrative savings is preempted. This paragraph shall not be construed to preempt State laws that impose restrictions on premiums based on health status, claims history, industry, age, gender, or other underwriting factors.</text></paragraph> <paragraph id="H72A71F226707487D88CF1119C5EEB3D"><enum>(3)</enum><header>No waiver of hipaa requirements</header><text>Nothing in this section shall be construed to change the obligation of health insurance issuers to comply with the requirements of title XXVII of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name> with respect to health insurance coverage offered to small employers in the small group market through a qualified health benefit purchasing coalition.</text></paragraph></subsection> <subsection id="H7EA6BC774D364365AA9DC30962BE1200"><enum>(h)</enum><header>Definition of small employer</header><text>For purposes of this section—</text> <paragraph id="H1DD6112CEB6542B09BF13019F83EE2EB"><enum>(1)</enum><header>In general</header><text>The term <term>small employer</term> means, with respect to any calendar year, any employer if such employer employed an average of at least 2 and not more than 50 qualified employees on business days during either of the 2 preceding calendar years. For purposes of the preceding sentence, a preceding calendar year may be taken into account only if the employer was in existence throughout such year.</text></paragraph> <paragraph id="H4B95107BD027493381DF85989021A442"><enum>(2)</enum><header>Employers not in existence in preceding year</header><text>In the case of an employer which was not in existence throughout the 1st preceding calendar year, the determination under paragraph (1) shall be based on the average number of qualified employees that it is reasonably expected such employer will employ on business days in the current calendar year.</text></paragraph></subsection></section></subchapter><after-quoted-block>.</after-quoted-block></quoted-block></paragraph> <paragraph id="HB2DA524DDB8049C5B357BDA889D7B152"><enum>(2)</enum><header>Conforming amendment</header><text>The table of subchapters for chapter 100 of such Code is amended by adding at the end the following item:</text> <quoted-block style="OLC" id="HFDB002B276C747BD83FFA291C57F4F7E" display-inline="no-display-inline"> <toc regeneration="no-regeneration"> <toc-entry level="subchapter">Subchapter D—Qualified health benefit purchasing coalition</toc-entry></toc><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph></subsection> <subsection id="HD50116F1A14A460E8D7BA9CFDF6CA654"><enum>(c)</enum><header>Effective date</header><text>The amendment made by subsection (a) shall apply to taxable years beginning after December 31, 2006.</text></subsection></section> <section id="H79DE5330D1164105887EF0070AB0954"><enum>513.</enum><header>State grant program for market innovation</header> <subsection id="H2B0CCF32B35E4ABBB7E832171C7F0854"><enum>(a)</enum><header>In general</header><text>The Secretary of Health and Human Services (in this section referred to as the <quote>Secretary</quote>) shall establish a program (in this section referred to as the <quote>program</quote>) to award demonstration grants under this section to States to allow States to demonstrate the effectiveness of innovative ways to increase access to health insurance through market reforms and other innovative means. Such innovative means may include (and are not limited to) any of the following:</text> <paragraph id="H3B629697A5044B38B5609B6771B3C23F"><enum>(1)</enum><text>Alternative group purchasing or pooling arrangements, such as purchasing cooperatives for small businesses, reinsurance pools, or high risk pools.</text></paragraph> <paragraph id="HD770B23F074345EF984EE464D03B0094"><enum>(2)</enum><text>Individual or small group market reforms.</text></paragraph> <paragraph id="H5D34A70AC3674A80847CE6A94382D102"><enum>(3)</enum><text>Consumer education and outreach.</text></paragraph> <paragraph id="H6CEF5123EAEF4185A5914174771C09D4"><enum>(4)</enum><text>Subsidies to individuals, employers, or both, in obtaining health insurance.</text></paragraph></subsection> <subsection id="HE6E0E0DF6BCD4DC3B9C3FBB000952589"><enum>(b)</enum><header>Scope; duration</header><text>The program shall be limited to not more than 10 States and to a total period of 5 years, beginning on the date the first demonstration grant is made.</text></subsection> <subsection id="H79BE7E57D27946D0A9C4A3DE0849EA00"><enum>(c)</enum><header>Conditions for demonstration grants</header> <paragraph id="HFAA5CBD7CEEC4B9DB21F1CEB35611BD3"><enum>(1)</enum><header>In general</header><text>The Secretary may not provide for a demonstration grant to a State under the program unless the Secretary finds that under the proposed demonstration grant—</text> <subparagraph id="H1471AC48E15145EF8421E4E2BF420742"><enum>(A)</enum><text>the State will provide for demonstrated increase of access for some portion of the existing uninsured population through a market innovation (other than merely through a financial expansion of a program initiated before the date of the enactment of this Act);</text></subparagraph> <subparagraph id="H2C0AC76F87B14D13A215707194426FEF"><enum>(B)</enum><text>the State will comply with applicable Federal laws;</text></subparagraph> <subparagraph id="H7BCC1242F42C4214865CD5C25928988E"><enum>(C)</enum><text>the State will not discriminate among participants on the basis of any health status-related factor (as defined in section 2791(d)(9) of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name>), except to the extent a State wishes to focus on populations that otherwise would not obtain health insurance because of such factors; and</text></subparagraph> <subparagraph id="H6A3C1FC052D94343AC67517B20838911"><enum>(D)</enum><text>the State will provide for such evaluation, in coordination with the evaluation required under subsection (d), as the Secretary may specify.</text></subparagraph></paragraph> <paragraph id="H7BB2CAB25E4E4817BA7D14026572ABDA"><enum>(2)</enum><header>Application</header><text>The Secretary shall not provide a demonstration grant under the program to a State unless—</text> <subparagraph id="H36C900B81101498182C39601DE757610"><enum>(A)</enum><text>the State submits to the Secretary such an application, in such a form and manner, as the Secretary specifies;</text></subparagraph> <subparagraph id="H4D8AAAC1842341B880CCD51CB0299C7C"><enum>(B)</enum><text>the application includes information regarding how the demonstration grant will address issues such as governance, targeted population, expected cost, and the continuation after the completion of the demonstration grant period; and</text></subparagraph> <subparagraph id="H64E6A8DDD1024B41AA58842810FDA19"><enum>(C)</enum><text>the Secretary determines that the demonstration grant will be used consistent with this section.</text></subparagraph></paragraph> <paragraph id="H580788A583F641B4000388A3C8BBE07"><enum>(3)</enum><header>Focus</header><text>A demonstration grant proposal under section need not cover all uninsured individuals in a State or all health care benefits with respect to such individuals.</text></paragraph></subsection> <subsection id="H6A9E174A70F4443BAAB91133F9E23BEA"><enum>(d)</enum><header>Evaluation</header><text>The Secretary shall enter into a contract with an appropriate entity outside the Department of Health and Human Services to conduct an overall evaluation of the program at the end of the program period. Such evaluation shall include an analysis of improvements in access, costs, quality of care, or choice of coverage, under different demonstration grants.</text></subsection> <subsection id="HABED6FCD5FC049FF9D92DB274DAA1EFA"><enum>(e)</enum><header>Option to provide for initial planning grants</header><text>Notwithstanding the previous provisions of this section, under the program the Secretary may provide for a portion of the amounts appropriated under subsection (f) (not to exceed $5,000,000) to be made available to any State for initial planning grants to permit States to develop demonstration grant proposals under the previous provisions of this section.</text></subsection> <subsection id="H30CE825A84704B9CACA44A534DEA00"><enum>(f)</enum><header>Authorization of appropriations</header><text>There are authorized to be appropriated $100,000,000 for each fiscal year to carry out this section. Amounts appropriated under this subsection shall remain available until expended.</text></subsection> <subsection id="H37B23DC3FB7D4C069141AC485CF9DBE9"><enum>(g)</enum><header>State defined</header><text>For purposes of this section, the term <term>State</term> has the meaning given such term for purposes of title XIX of the <act-name parsable-cite="SSA">Social Security Act</act-name>.</text></subsection></section> <section id="H16B9E239585F4D5AAFE0C9222EDFF2C7"><enum>514.</enum><header>Grant program to facilitate health benefits information for small employers</header> <subsection id="H4AE9EE56ED5746AEB18EC443375F3922"><enum>(a)</enum><header>In general</header><text>The Small Business Administration shall award grants to 1 or more States, local governments, and non-profit organizations for the purposes of—</text> <paragraph id="H90E384D598BC4C0797EE8CE891AA6C7"><enum>(1)</enum><text>demonstrating new and effective ways to provide information about the benefits of health insurance to small employers, including tax benefits, increased productivity of employees, and decreased turnover of employees,</text></paragraph> <paragraph id="H0D28CBF382D24652857406AC8437F733"><enum>(2)</enum><text>making employers aware of their current rights in the marketplace under State and Federal health insurance reforms, and</text></paragraph> <paragraph id="HE5BD5ADFA6A64299BA29CBA802ED2615"><enum>(3)</enum><text>making employers aware of the tax treatment of insurance premiums.</text></paragraph></subsection> <subsection id="H7248EA4064F844218CE0AB00F9D6DF44"><enum>(b)</enum><header>Authorization</header><text>There is authorized to be appropriated $10,000,000 for each of the first 5 fiscal years beginning after the date of the enactment of this Act for grants under subsection (a).</text></subsection></section> <section id="H7F0573A3A6204783B3F58826C5D46B1"><enum>515.</enum><header>State grant program for market innovation</header> <subsection id="H4599D4C83AEA4EDB8026326BFFD9E4D8"><enum>(a)</enum><header>In general</header><text>The Secretary of Health and Human Services (in this section referred to as the <quote>Secretary</quote>) shall establish a program (in this section referred to as the <quote>program</quote>) to award demonstration grants under this section to States to allow States to demonstrate the effectiveness of innovative ways to increase access to health insurance through market reforms and other innovative means. Such innovative means may include (and are not limited to) any of the following:</text> <paragraph id="HA40DA1D4ECBC45E5A071A0751F833100"><enum>(1)</enum><text>Alternative group purchasing or pooling arrangements, such as purchasing cooperatives for small businesses, reinsurance pools, or high risk pools.</text></paragraph> <paragraph id="H7B631808969C44FEAD559C20441747AA"><enum>(2)</enum><text>Individual or small group market reforms.</text></paragraph> <paragraph id="H2C19476F5F714C579397D9977DF86EB"><enum>(3)</enum><text>Consumer education and outreach.</text></paragraph> <paragraph id="HF281D1C2E6E741989391B75D25D18400"><enum>(4)</enum><text>Subsidies to individuals, employers, or both, in obtaining health insurance.</text></paragraph></subsection> <subsection id="H06ABE7A8085B49ABB8B5FDE873D34400"><enum>(b)</enum><header>Scope; duration</header><text>The program shall be limited to not more than 10 States and to a total period of 5 years, beginning on the date the first demonstration grant is made.</text></subsection> <subsection id="H6082A3A9226F4E6B90B600DD8E57BDA0"><enum>(c)</enum><header>Conditions for demonstration grants</header> <paragraph id="H495793FB02FE4D4597ED6CB8BBB44CC"><enum>(1)</enum><header>In general</header><text>The Secretary may not provide for a demonstration grant to a State under the program unless the Secretary finds that under the proposed demonstration grant—</text> <subparagraph id="H703882CD5F274F4A90789570DD3190"><enum>(A)</enum><text>the State will provide for demonstrated increase of access for some portion of the existing uninsured population through a market innovation (other than merely through a financial expansion of a program initiated before the date of the enactment of this Act);</text></subparagraph> <subparagraph id="H74FBBA2019024FAAA5B45D2EC8FF65E6"><enum>(B)</enum><text>the State will comply with applicable Federal laws;</text></subparagraph> <subparagraph id="H7E242421F73C444EA4A13B92AE4E4709"><enum>(C)</enum><text>the State will not discriminate among participants on the basis of any health status-related factor (as defined in section 2791(d)(9) of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name>), except to the extent a State wishes to focus on populations that otherwise would not obtain health insurance because of such factors; and</text></subparagraph> <subparagraph id="H3119960661B6407EB6BD26FBAF249D58"><enum>(D)</enum><text>the State will provide for such evaluation, in coordination with the evaluation required under subsection (d), as the Secretary may specify.</text></subparagraph></paragraph> <paragraph id="H43F97A4D8F4D46C990B95543EB2339C2"><enum>(2)</enum><header>Application</header><text>The Secretary shall not provide a demonstration grant under the program to a State unless—</text> <subparagraph id="HCF2B11C7512F4E4DB080706B391D853B"><enum>(A)</enum><text>the State submits to the Secretary such an application, in such a form and manner, as the Secretary specifies;</text></subparagraph> <subparagraph id="H426E16F653E04CCA98B3F2FD75206B00"><enum>(B)</enum><text>the application includes information regarding how the demonstration grant will address issues such as governance, targeted population, expected cost, and the continuation after the completion of the demonstration grant period; and</text></subparagraph> <subparagraph id="H678F9BDEC8FC4331A98B2C71B516B6D"><enum>(C)</enum><text>the Secretary determines that the demonstration grant will be used consistent with this section.</text></subparagraph></paragraph> <paragraph id="H498BC7DB31824C998D00EB930013C8FD"><enum>(3)</enum><header>Focus</header><text>A demonstration grant proposal under section need not cover all uninsured individuals in a State or all health care benefits with respect to such individuals.</text></paragraph></subsection> <subsection id="HCB716023C695414790008500BEFC8C00"><enum>(d)</enum><header>Evaluation</header><text>The Secretary shall enter into a contract with an appropriate entity outside the Department of Health and Human Services to conduct an overall evaluation of the program at the end of the program period. Such evaluation shall include an analysis of improvements in access, costs, quality of care, or choice of coverage, under different demonstration grants.</text></subsection> <subsection id="H353FCA7194E34430A07B04E15403658F"><enum>(e)</enum><header>Option to provide for initial planning grants</header><text>Notwithstanding the previous provisions of this section, under the program the Secretary may provide for a portion of the amounts appropriated under subsection (f) (not to exceed $5,000,000) to be made available to any State for initial planning grants to permit States to develop demonstration grant proposals under the previous provisions of this section.</text></subsection> <subsection id="H28050D8414C2420384F2F6FBD1F1AFC4"><enum>(f)</enum><header>Authorization of appropriations</header><text>There are authorized to be appropriated $100,000,000 for each fiscal year to carry out this section. Amounts appropriated under this subsection shall remain available until expended.</text></subsection> <subsection id="HDFF3514F369C455EB76210C754FD79"><enum>(g)</enum><header>State defined</header><text>For purposes of this section, the term <term>State</term> has the meaning given such term for purposes of title XIX of the <act-name parsable-cite="SSA">Social Security Act</act-name>.</text></subsection></section></subtitle> <enum>VI</enum><header>Effective dates; coordination in implementation</header> <section id="HED6BD84EC3D24B0790C13C699E6BB4E"><enum>601.</enum><header>Effective dates</header> <subsection id="H3668494D0A9E4F49BD25B6A299BA364C"><enum>(a)</enum><header>Group health coverage</header> <paragraph id="H1F652302CA574F3D85B31EE8C3EA1203"><enum>(1)</enum><header>In general</header><text>Subject to paragraph (2) and subsection (d), the amendments made by sections 201(a), 401, 501, and 502 (and title I insofar as it relates to such sections) shall apply with respect to group health plans, and health insurance coverage offered in connection with group health plans, for plan years beginning on or after October 1, 2006 (in this section referred to as the <quote>general effective date</quote>).</text></paragraph> <paragraph id="H3628075779F64243AA3F12E19F9D5F19"><enum>(2)</enum><header>Treatment of collective bargaining agreements</header><text>In the case of a group health plan maintained pursuant to one or more collective bargaining agreements between employee representatives and one or more employers ratified before the date of the enactment of this Act, the amendments made by sections 201(a), 401, 501, and 502 (and title I insofar as it relates to such sections) shall not apply to plan years beginning before the later of—</text> <subparagraph id="H57CBAE6B92144CF3BEFE427F00C8582"><enum>(A)</enum><text>the date on which the last collective bargaining agreements relating to the plan terminates (excluding any extension thereof agreed to after the date of the enactment of this Act); or</text></subparagraph> <subparagraph id="H71C3DFB394A44B15B8FD000976D3C8B"><enum>(B)</enum><text>the general effective date;</text></subparagraph><continuation-text continuation-text-level="paragraph">but shall apply not later than 1 year after the general effective date. For purposes of subparagraph (A), any plan amendment made pursuant to a collective bargaining agreement relating to the plan which amends the plan solely to conform to any requirement added by this Act shall not be treated as a termination of such collective bargaining agreement.</continuation-text></paragraph></subsection> <subsection id="HD6489573638A450AB7890417757B127D"><enum>(b)</enum><header>Individual health insurance coverage</header><text>Subject to subsection (d), the amendments made by section 202 shall apply with respect to individual health insurance coverage offered, sold, issued, renewed, in effect, or operated in the individual market on or after the general effective date.</text></subsection> <subsection id="H137CDE24D4944996ACE3129D675B104D"><enum>(c)</enum><header>Treatment of religious nonmedical providers</header> <paragraph id="H3A0B9E8351B54204B6DB27F2727EE7C0"><enum>(1)</enum><header>In general</header><text>Nothing in this Act (or the amendments made thereby) shall be construed to—</text> <subparagraph id="H0343C66B608447D89E4C4D3B862532AE"><enum>(A)</enum><text>restrict or limit the right of group health plans, and of health insurance issuers offering health insurance coverage, to include as providers religious nonmedical providers;</text></subparagraph> <subparagraph id="HE370EB7BFA874F02B8AA70E8DCD3EFF7"><enum>(B)</enum><text>require such plans or issuers to—</text> <clause id="H2FD2FD55DC29424DA44CF56B96BDFEB6"><enum>(i)</enum><text>utilize medically based eligibility standards or criteria in deciding provider status of religious nonmedical providers;</text></clause> <clause id="H0C5AFD8D502B470F9D0054506EB018F5"><enum>(ii)</enum><text>use medical professionals or criteria to decide patient access to religious nonmedical providers;</text></clause> <clause id="H3377D79383124C65A14F966E24E58BFE"><enum>(iii)</enum><text>utilize medical professionals or criteria in making decisions in internal or external appeals regarding coverage for care by religious nonmedical providers; or</text></clause> <clause id="HB73E0A35FF0E44C1B2302B3FEE91693F"><enum>(iv)</enum><text>compel a participant or beneficiary to undergo a medical examination or test as a condition of receiving health insurance coverage for treatment by a religious nonmedical provider; or</text></clause></subparagraph> <subparagraph id="HCE12F40DDB0F48B9B60041EEFDC7E0DE"><enum>(C)</enum><text>require such plans or issuers to exclude religious nonmedical providers because they do not provide medical or other required data, if such data is inconsistent with the religious nonmedical treatment or nursing care provided by the provider.</text></subparagraph></paragraph> <paragraph id="HE4D14C10199A468FBA814970AA91BFBB"><enum>(2)</enum><header>Religious nonmedical provider</header><text>For purposes of this subsection, the term <term>religious nonmedical provider</term> means a provider who provides no medical care but who provides only religious nonmedical treatment or religious nonmedical nursing care.</text></paragraph></subsection> <subsection id="HCA2373FC12364F2598191E58AD3DE7FC"><enum>(d)</enum><header>Transition for notice requirement</header><text>The disclosure of information required under section 121 of this Act shall first be provided pursuant to—</text> <paragraph id="H92938C91FA484B8DBD00ECC2577E113"><enum>(1)</enum><text>subsection (a) with respect to a group health plan that is maintained as of the general effective date, not later than 30 days before the beginning of the first plan year to which title I applies in connection with the plan under such subsection; or</text></paragraph> <paragraph id="HD04563246F38469B99E86BF026762681"><enum>(2)</enum><text>subsection (b) with respect to an individual health insurance coverage that is in effect as of the general effective date, not later than 30 days before the first date as of which title I applies to the coverage under such subsection.</text></paragraph></subsection></section> <section id="H634FFBE3A53842679BEBB30016675B75"><enum>602.</enum><header>Coordination in implementation</header><text display-inline="no-display-inline">The Secretary of Labor and the Secretary of Health and Human Services shall ensure, through the execution of an interagency memorandum of understanding among such Secretaries, that—</text> <paragraph id="HA5995FE9361240C98693DF002EE182A9"><enum>(1)</enum><text>regulations, rulings, and interpretations issued by such Secretaries relating to the same matter over which such Secretaries have responsibility under the provisions of this Act (and the amendments made thereby) are administered so as to have the same effect at all times; and</text></paragraph> <paragraph id="HB6521F644793407D90E4A4E25E8FE58B"><enum>(2)</enum><text>coordination of policies relating to enforcing the same requirements through such Secretaries in order to have a coordinated enforcement strategy that avoids duplication of enforcement efforts and assigns priorities in enforcement.</text></paragraph></section> <section id="H719D848956284762AB2359EDB4FC9B00"><enum>603.</enum><header>Severability</header><text display-inline="no-display-inline">If any provision of this Act, an amendment made by this Act, or the application of such provision or amendment to any person or circumstance is held to be unconstitutional, the remainder of this Act, the amendments made by this Act, and the application of the provisions of such to any person or circumstance shall not be affected thereby.</text></section> <enum>VII</enum><header>Miscellaneous provisions</header> <section id="HEDE49D65BEC347A693A9E4E42EFBEFD"><enum>701.</enum><header>No impact on Social Security Trust Fund</header> <subsection id="H9C6920D1EAFC4F35B4454CB29CF4B1BC"><enum>(a)</enum><header>In general</header><text>Nothing in this Act (or an amendment made by this Act) shall be construed to alter or amend the <act-name parsable-cite="SSA">Social Security Act</act-name> (or any regulation promulgated under that Act).</text></subsection> <subsection id="H6F60D648E9CD46D2A051EC67ADDDB74"><enum>(b)</enum><header>Transfers</header> <paragraph id="HFB51BBF243F24DCA8352ECFB475EF8E"><enum>(1)</enum><header>Estimate of Secretary</header><text>The Secretary of the Treasury shall annually estimate the impact that the enactment of this Act has on the income and balances of the trust funds established under section 201 of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/401">42 U.S.C. 401</external-xref>).</text></paragraph> <paragraph id="H4A66BA4719344DBCA9797EF914BD07F"><enum>(2)</enum><header>Transfer of funds</header><text>If, under paragraph (1), the Secretary of the Treasury estimates that the enactment of this Act has a negative impact on the income and balances of the trust funds established under section 201 of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/401">42 U.S.C. 401</external-xref>), the Secretary shall transfer, not less frequently than quarterly, from the general revenues of the Federal Government an amount sufficient so as to ensure that the income and balances of such trust funds are not reduced as a result of the enactment of such Act.</text></paragraph></subsection></section>