,,ii #aacth ,,congress #ast ,session ,s4 #ahfj ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,december #ai1 #bjac,mr4 ,heller introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to reform the medical liability system1 improve access to health care for rural and indigent patients1 enhance access to affordable prescription drugs1 and for other purposes4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,steps ,toward ,access and ,reform ,act of #bjac or the ,,star ,act of #bjac4 7b7 ,table of contents ,the table of contents of this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4,,title ,i--,,medical ,,liability ,r,e,f,o,r,m,sec4 #aja4 ,encouraging speedy resolution of claims4,sec4 #ajb4 ,compensating patient injury4,sec4 #ajc4 ,maximizing patient recovery4,sec4 #ajd4 ,additional collateral source benefits4,sec4 #aje4 ,punitive damages4,sec4 #ajf4 ,authorization of payment of future damages to claimants in health care lawsuits4,sec4 #ajg4 ,effect on other laws4,sec4 #ajh4 ,state flexibility and protection of ,states' rights4,sec4 #aji4 ,applicability2 effective date4,sec4 #aaj4 ,sense of ,congress4,sec4 #aaa4 ,definitions4,,title ,,ii--,,improving ,,access ,,for ,,rural ,,and ,,indigent ,p,a,t,i,e,n,t,s,sec4 #bja4 ,improving access for rural and indigent patients4,,title ,,iii--,,providing ,,for ,,affordable ,,prescription ,d,r,u,g,s,sec4 #cja4 ,providing for affordable prescription drugs4,,title ,,iv--,expanding ,choices by ,allowing ,americans to ,buy ,health ,care ,coverage ,across ,state ,lines,sec4 #dja4 ,interstate purchasing of health insurance4 ,i ,,medical ,,liability ,,reform #aja4 ,encouraging speedy resolution of claims ,the time for the commencement of a health care lawsuit shall be #c years after the date of manifestation of injury or #a year after the claimant discovers1 or through the use of reasonable diligence should have discovered1 the injury1 whichever occurs first4 ,in no event shall the time for commencement of a health care lawsuit exceed #c years after the date of manifestation of injury unless tolled for any of the following-- 7#a7 upon proof of fraud2 7#b7 intentional concealment2 or 7#c7 the presence of a foreign body1 which has no therapeutic or diagnostic purpose or effect1 in the body of the injured person4 ,actions by a minor shall be commenced within #c years from the date of the alleged manifestation of injury except that actions by a minor under the full age of #f years shall be commenced within #c years of manifestation of injury or prior to the minor's #hth birthday1 whichever provides a longer period4 ,such time limitation shall be tolled for minors for any period during which a parent or guardian and a health care provider or health care organization have committed fraud or collusion in the failure to bring an action on behalf of the injured minor4 #ajb4 ,compensating patient injury 7a7 ,unlimited ,amount of ,damages for ,actual ,economic ,losses in ,health ,care ,lawsuits ,in any health care lawsuit1 nothing in this title shall limit a claimant's recovery of the full amount of the available economic damages1 notwithstanding the limitation in subsection 7b74 7b7 ,additional ,noneconomic ,damages ,in any health care lawsuit1 the amount of noneconomic damages1 if available1 shall not exceed #bej1jjj1 regardless of the number of parties against whom the action is brought or the number of separate claims or actions brought with respect to the same injury4 7c7 ,no ,discount of ,award for ,noneconomic ,damages ,for purposes of applying the limitation in subsection 7b71 future noneconomic damages shall not be discounted to present value4 ,the jury shall not be informed about the maximum award for noneconomic damages4 ,an award for noneconomic damages in excess of #bej1jjj shall be reduced either before the entry of judgment1 or by amendment of the judgment after entry of judgment1 and such reduction shall be made before accounting for any other reduction in damages required by law4 ,if separate awards are rendered for past and future noneconomic damages and the combined awards exceed #bej1jjj1 the future noneconomic damages shall be reduced first4 7d7 ,fair ,share ,rule ,in any health care lawsuit1 each party shall be liable for that party's several share of any damages only and not for the share of any other person4 ,each party shall be liable only for the amount of damages allocated to such party in direct proportion to such party's percentage of responsibility4 ,whenever a judgment of liability is rendered as to any party1 a separate judgment shall be rendered against each such party for the amount allocated to such party4 ,for purposes of this section1 the trier of fact shall determine the proportion of responsibility of each party for the claimant's harm4 #ajc4 ,maximizing patient recovery 7a7 ,court ,supervision of ,share of ,damages ,actually ,paid to ,claimants ,in any health care lawsuit1 the court shall supervise the arrangements for payment of damages to protect against conflicts of interest that may have the effect of reducing the amount of damages awarded that are actually paid to claimants4 ,in particular1 in any health care lawsuit in which the attorney for a party claims a financial stake in the outcome by virtue of a contingent fee1 the court shall have the power to restrict the payment of a claimant's damage recovery to such attorney1 and to redirect such damages to the claimant based upon the interests of justice and principles of equity4 ,in no event shall the total of all contingent fees for representing all claimants in a health care lawsuit exceed the following limits3 7#a7 #dj percent of the first #ej1jjj recovered by the claimants4 7#b7 #cca_/c percent of the next #ej1jjj recovered by the claimants4 7#c7 #be percent of the next #ejj1jjj recovered by the claimants4 7#d7 #ae percent of any amount by which the recovery by the claimants is in excess of #fjj1jjj4 7b7 ,applicability ,the limitations in this section shall apply whether the recovery is by judgment1 settlement1 mediation1 arbitration1 or any other form of alternative dispute resolution4 ,in a health care lawsuit involving a minor or incompetent person1 a court retains the authority to authorize or approve a fee that is less than the maximum permitted under this section4 ,the requirement for court supervision in the first two sentences of subsection 7a7 applies only in civil actions4 #ajd4 ,additional collateral source benefits ,in any health care lawsuit involving injury or wrongful death1 any party may introduce evidence of collateral source benefits4 ,if a party elects to introduce such evidence1 any opposing party may introduce evidence of any amount paid or contributed or reasonably likely to be paid or contributed in the future by or on behalf of the opposing party to secure the right to such collateral source benefits4 ,no provider of collateral source benefits shall recover any amount against the claimant or receive any lien or credit against the claimant's recovery or be equitably or legally subrogated to the right of the claimant in a health care lawsuit involving injury or wrongful death4 ,this section shall apply to any health care lawsuit that is settled as well as a health care lawsuit that is resolved by a fact finder4 ,this section shall not apply to section #ahfb7;b7 7#db ,u4,s4,c4 #aciey7b77 or section #aijb7;a77#be7 7#db ,u4,s4,c4 #acif;a7a77#be77 of the ,social ,security ,act4 #aje4 ,punitive damages 7a7 ,in ,general ,punitive damages may1 if otherwise permitted by applicable ,state or ,federal law1 be awarded against any person in a health care lawsuit only if it is proven by clear and convincing evidence that such person acted with malicious intent to injure the claimant1 or that such person deliberately failed to avoid unnecessary injury that such person knew the claimant was substantially certain to suffer4 ,in any health care lawsuit where no judgment for compensatory damages is rendered against such person1 no punitive damages may be awarded with respect to the claim in such lawsuit4 ,no demand for punitive damages shall be included in a health care lawsuit as initially filed4 ,a court may allow a claimant to file an amended pleading for punitive damages only upon a motion by the claimant and after a finding by the court1 upon review of supporting and opposing affidavits or after a hearing1 after weighing the evidence1 that the claimant has established by a substantial probability that the claimant will prevail on the claim for punitive damages4 ,at the request of any party in a health care lawsuit1 the trier of fact shall consider in a separate proceeding-- 7#a7 whether punitive damages are to be awarded and the amount of such award2 and 7#b7 the amount of punitive damages following a determination of punitive liability4 ,if a separate proceeding is requested1 evidence relevant only to the claim for punitive damages1 as determined by applicable ,state law1 shall be inadmissible in any proceeding to determine whether compensatory damages are to be awarded4 7b7 ,determining ,amount of ,punitive ,damages 7#a7 ,factors considered ,in determining the amount of punitive damages1 if awarded1 in a health care lawsuit1 the trier of fact shall consider only the following-- 7,a7 the severity of the harm caused by the conduct of such party2 7,b7 the duration of the conduct or any concealment of it by such party2 7,c7 the profitability of the conduct to such party2 7,d7 the number of products sold or medical procedures rendered for compensation1 as the case may be1 by such party1 of the kind causing the harm complained of by the claimant2 7,e7 any criminal penalties imposed on such party1 as a result of the conduct complained of by the claimant2 and 7,f7 the amount of any civil fines assessed against such party as a result of the conduct complained of by the claimant4 7#b7 ,maximum award ,the amount of punitive damages1 if awarded1 in a health care lawsuit may not exceed #bej1jjj or two times the amount of economic damages awarded1 whichever is greater4 ,the jury shall not be informed of this limitation4 7c7 ,no ,punitive ,damages for ,products ,that ,comply ,with ,,fda ,standards 7#a7 ,in general 7,a7 ,no punitive damages may be awarded against the manufacturer or distributor of a medical product1 or a supplier of any component or raw material of such medical product1 based on a claim that such product caused the claimant's harm where-- 7i7 7,i7 such medical product was subject to premarket approval1 clearance1 or licensure by the ,food and ,drug ,administration with respect to the safety of the formulation or performance of the aspect of such medical product which caused the claimant's harm or the adequacy of the packaging or labeling of such medical product2 and 7,,ii7 such medical product was so approved1 cleared1 or licensed2 or 7ii7 such medical product is generally recognized among qualified experts as safe and effective pursuant to conditions established by the ,food and ,drug ,administration and applicable ,food and ,drug ,administration regulations1 including without limitation those related to packaging and labeling1 unless the ,food and ,drug ,administration has determined that such medical product was not manufactured or distributed in substantial compliance with applicable ,food and ,drug ,administration statutes and regulations4 7,b7 ,rule of construction ,subparagraph 7,a7 may not be construed as establishing the obligation of the ,food and ,drug ,administration to demonstrate affirmatively that a manufacturer1 distributor1 or supplier referred to in such subparagraph meets any of the conditions described in such subparagraph4 7#b7 ,liability of health care providers ,a health care provider who prescribes1 or who dispenses pursuant to a prescription1 a medical product approved1 licensed1 or cleared by the ,food and ,drug ,administration shall not be named as a party to a product liability lawsuit involving such product and shall not be liable to a claimant in a class action lawsuit against the manufacturer1 distributor1 or seller of such product4 ,nothing in this paragraph prevents a court from consolidating cases involving health care providers and cases involving products liability claims against the manufacturer1 distributor1 or product seller of such medical product4 7#c7 ,packaging ,in a health care lawsuit for harm which is alleged to relate to the adequacy of the packaging or labeling of a drug which is required to have tamper-resistant packaging under regulations of the ,secretary of ,health and ,human ,services 7including labeling regulations related to such packaging71 the manufacturer or product seller of the drug shall not be held liable for punitive damages unless such packaging or labeling is found by the trier of fact by clear and convincing evidence to be substantially out of compliance with such regulations4 7#d7 ,exception ,paragraph 7#a7 shall not apply in any health care lawsuit in which-- 7,a7 a person1 before or after premarket approval1 clearance1 or licensure of such medical product1 knowingly misrepresented to or withheld from the ,food and ,drug ,administration information that is required to be submitted under the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 or section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 that is material and is causally related to the harm which the claimant allegedly suffered2 or 7,b7 a person made an illegal payment to an official of the ,food and ,drug ,administration for the purpose of either securing or maintaining approval1 clearance1 or licensure of such medical product4 #ajf4 ,authorization of payment of future damages to claimants in health care lawsuits 7a7 ,in ,general ,in any health care lawsuit1 if an award of future damages1 without reduction to present value1 equaling or exceeding #ej1jjj is made against a party with sufficient insurance or other assets to fund a periodic payment of such a judgment1 the court shall1 at the request of any party1 enter a judgment ordering that the future damages be paid by periodic payments4 ,in any health care lawsuit1 the court may be guided by the ,uniform ,periodic ,payment of ,judgments ,act promulgated by the ,national ,conference of ,commissioners on ,uniform ,state ,laws4 7b7 ,applicability ,this section applies to all actions which have not been first set for trial or retrial before the effective date of this ,act4 #ajg4 ,effect on other laws 7a7 ,vaccine ,injury 7#a7 ,to the extent that title ,,xxi of the ,public ,health ,service ,act establishes a ,federal rule of law applicable to a civil action brought for a vaccine-related injury or death-- 7,a7 this title does not affect the application of the rule of law to such an action2 and 7,b7 any rule of law prescribed by this title in conflict with a rule of law of such title ,,xxi shall not apply to such action4 7#b7 ,if there is an aspect of a civil action brought for a vaccine-related injury or death to which a ,federal rule of law under title ,,xxi of the ,public ,health ,service ,act does not apply1 then this title or otherwise applicable law 7as determined under this title7 will apply to such aspect of such action4 7b7 ,other ,federal ,law ,except as provided in this section1 nothing in this title shall be deemed to affect any defense available to a defendant in a health care lawsuit or action under any other provision of ,federal law4 #ajh4 ,state flexibility and protection of ,states' rights 7a7 ,health ,care ,lawsuits ,the provisions governing health care lawsuits set forth in this title preempt1 subject to subsections 7b7 and 7c71 ,state law to the extent that ,state law prevents the application of any provisions of law established by or under this title4 ,the provisions governing health care lawsuits set forth in this title supersede chapter #aga of title #bh1 ,united ,states ,code1 to the extent that such chapter-- 7#a7 provides for a greater amount of damages or contingent fees1 a longer period in which a health care lawsuit may be commenced1 or a reduced applicability or scope of periodic payment of future damages1 than provided in this title2 or 7#b7 prohibits the introduction of evidence regarding collateral source benefits1 or mandates or permits subrogation or a lien on collateral source benefits4 7b7 ,protection of ,states' ,rights and ,other ,laws 7#a7 ,any issue that is not governed by any provision of law established by or under this title 7including ,state standards of negligence7 shall be governed by otherwise applicable ,state or ,federal law4 7#b7 ,this title shall not preempt or supersede any ,state or ,federal law that imposes greater procedural or substantive protections for health care providers and health care organizations from liability1 loss1 or damages than those provided by this title or create a cause of action4 7c7 ,state ,flexibility ,no provision of this title shall be construed to preempt-- 7#a7 any ,state law 7whether effective before1 on1 or after the date of the enactment of this ,act7 that specifies a particular monetary amount of compensatory or punitive damages 7or the total amount of damages7 that may be awarded in a health care lawsuit1 regardless of whether such monetary amount is greater or lesser than is provided for under this title1 notwithstanding section #ajd7;a72 or 7#b7 any defense available to a party in a health care lawsuit under any other provision of ,state or ,federal law4 #aji4 ,applicability2 effective date ,this title shall apply to any health care lawsuit brought in a ,federal or ,state court1 or subject to an alternative dispute resolution system1 that is initiated on or after the date of the enactment of this ,act1 except that any health care lawsuit arising from an injury occurring prior to the date of the enactment of this ,act shall be governed by the applicable statute of limitations provisions in effect at the time the injury occurred4 #aaj4 ,sense of ,congress ,it is the sense of ,congress that a health insurer should be liable for damages for harm caused when it makes a decision as to what care is medically necessary and appropriate4 #aaa4 ,definitions ,in this title3 7#a7 ,alternative dispute resolution system2 ,,adr ,the term alternative dispute resolution system or ,,adr means a system that provides for the resolution of health care lawsuits in a manner other than through a civil action brought in a ,state or ,federal court4 7#b7 ,claimant ,the term claimant means any person who brings a title1 including a person who asserts or claims a right to legal or equitable contribution1 indemnity1 or subrogation1 arising out of a health care liability claim or action1 and any person on whose behalf such a claim is asserted or such an action is brought1 whether deceased1 incompetent1 or a minor4 7#c7 ,collateral source benefits ,the term collateral source benefits means any amount paid or reasonably likely to be paid in the future to or on behalf of the claimant1 or any service1 product1 or other benefit provided or reasonably likely to be provided in the future to or on behalf of the claimant1 as a result of the injury or wrongful death1 pursuant to-- 7,a7 any ,state or ,federal health1 sickness1 income-disability1 accident1 or workers' compensation law2 7,b7 any health1 sickness1 income-disability1 or accident insurance that provides health benefits or income-disability coverage2 7,c7 any contract or agreement of any group1 organization1 partnership1 or corporation to provide1 pay for1 or reimburse the cost of medical1 hospital1 dental1 or income-disability benefits2 and 7,d7 any other publicly or privately funded program4 7#d7 ,compensatory damages ,the term compensatory damages means objectively verifiable monetary losses incurred as a result of the provision of1 use of1 or payment for 7or failure to provide1 use1 or pay for7 health care services or medical products1 such as past and future medical expenses1 loss of past and future earnings1 cost of obtaining domestic services1 loss of employment1 and loss of business or employment opportunities1 damages for physical and emotional pain1 suffering1 inconvenience1 physical impairment1 mental anguish1 disfigurement1 loss of enjoyment of life1 loss of society and companionship1 loss of consortium 7other than loss of domestic service71 hedonic damages1 injury to reputation1 and all other nonpecuniary losses of any kind or nature4 ,the term compensatory damages includes economic damages and noneconomic damages1 as such terms are defined in this section4 7#e7 ,contingent fee ,the term contingent fee includes all compensation to any person or persons which is payable only if a recovery is effected on behalf of one or more claimants4 7#f7 ,economic damages ,the term economic damages means objectively verifiable monetary losses incurred as a result of the provision of1 use of1 or payment for 7or failure to provide1 use1 or pay for7 health care services or medical products1 such as past and future medical expenses1 loss of past and future earnings1 cost of obtaining domestic services1 loss of employment1 and loss of business or employment opportunities4 7#g7 ,health care lawsuit ,the term health care lawsuit means any health care liability claim concerning the provision of health care goods or services or any medical product affecting interstate commerce1 or any health care liability action concerning the provision of health care goods or services or any medical product affecting interstate commerce1 brought in a ,state or ,federal court or pursuant to an alternative dispute resolution system1 against a health care provider1 a health care organization1 or the manufacturer1 distributor1 supplier1 marketer1 promoter1 or seller of a medical product1 regardless of the theory of liability on which the claim is based1 or the number of claimants1 plaintiffs1 defendants1 or other parties1 or the number of claims or causes of action1 in which the claimant alleges a health care liability claim4 ,such term does not include a claim or action which is based on criminal liability2 which seeks civil fines or penalties paid to ,federal1 ,state1 or local government2 or which is grounded in antitrust4 7#h7 ,health care liability action ,the term health care liability action means a civil action brought in a ,state or ,federal court or pursuant to an alternative dispute resolution system1 against a health care provider1 a health care organization1 or the manufacturer1 distributor1 supplier1 marketer1 promoter1 or seller of a medical product1 regardless of the theory of liability on which the claim is based1 or the number of plaintiffs1 defendants1 or other parties1 or the number of causes of action1 in which the claimant alleges a health care liability claim4 7#i7 ,health care liability claim ,the term health care liability claim means a demand by any person1 whether or not pursuant to ,,adr1 against a health care provider1 health care organization1 or the manufacturer1 distributor1 supplier1 marketer1 promoter1 or seller of a medical product1 including1 but not limited to1 third-party claims1 cross-claims1 counter-claims1 or contribution claims1 which are based upon the provision of1 use of1 or payment for 7or the failure to provide1 use1 or pay for7 health care services or medical products1 regardless of the theory of liability on which the claim is based1 or the number of plaintiffs1 defendants1 or other parties1 or the number of causes of action4 7#aj7 ,health care organization ,the term health care organization means any person or entity which is obligated to provide or pay for health benefits under any health plan1 including any person or entity acting under a contract or arrangement with a health care organization to provide or administer any health benefit4 7#aa7 ,health care provider ,the term health care provider means any person or entity required by ,state or ,federal laws or regulations to be licensed1 registered1 or certified to provide health care services1 and being either so licensed1 registered1 or certified1 or exempted from such requirement by other statute or regulation4 7#ab7 ,health care goods or services ,the term health care goods or services means any goods or services provided by a health care organization1 provider1 or by any individual working under the supervision of a health care provider1 that relates to the diagnosis1 prevention1 or treatment of any human disease or impairment1 or the assessment or care of the health of human beings4 7#ac7 ,malicious intent to injure ,the term malicious intent to injure means intentionally causing or attempting to cause physical injury other than providing health care goods or services4 7#ad7 ,medical product ,the term medical product means a drug1 device1 or biological product intended for humans1 and the terms drug1 device1 and biological product have the meanings given such terms in sections #bja7;g77#a7 and #bja7;h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;g77#a7 and 7h77 and section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a771 respectively1 including any component or raw material used therein1 but excluding health care services4 7#ae7 ,noneconomic damages ,the term noneconomic damages means damages for physical and emotional pain1 suffering1 inconvenience1 physical impairment1 mental anguish1 disfigurement1 loss of enjoyment of life1 loss of society and companionship1 loss of consortium 7other than loss of domestic service71 hedonic damages1 injury to reputation1 and all other nonpecuniary losses of any kind or nature4 7#af7 ,punitive damages ,the term punitive damages means damages awarded1 for the purpose of punishment or deterrence1 and not solely for compensatory purposes1 against a health care provider1 health care organization1 or a manufacturer1 distributor1 or supplier of a medical product4 ,punitive damages are neither economic nor noneconomic damages4 7#ag7 ,recovery ,the term recovery means the net sum recovered after deducting any disbursements or costs incurred in connection with prosecution or settlement of the claim1 including all costs paid or advanced by any person4 ,costs of health care incurred by the plaintiff and the attorneys' office overhead costs or charges for legal services are not deductible disbursements or costs for such purpose4 7#ah7 ,state ,the term ,state means each of the several ,states1 the ,district of ,columbia1 the ,commonwealth of ,puerto ,rico1 the ,virgin ,islands1 ,guam1 ,american ,samoa1 the ,northern ,mariana ,islands1 the ,trust ,territory of the ,pacific ,islands1 and any other territory or possession of the ,united ,states1 or any political subdivision thereof4 ,,ii ,,improving ,,access ,,for ,,rural ,,and ,,indigent ,,patients #bja4 ,improving access for rural and indigent patients 7a7 ,loan forgiveness for primary care providers 7#a7 ,in general ,the ,secretary of ,health and ,human ,services shall carry out a program of entering into contracts with eligible individuals under which-- 7,a7 the individual agrees to serve for a period of not less than #d years as a primary care provider in a medically underserved community 7as defined in section #gii;,b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #biep772 and 7,b7 in consideration of such service1 the ,secretary agrees to pay not more than #ajj1jjj on the principal and interest on the individual's graduate educational loans4 7#b7 ,eligibility ,to be eligible to enter into a contract under subsection 7#a71 an individual must-- 7,a7 have a graduate degree in medicine1 osteopathic medicine1 or another health profession from an accredited 7as determined by the ,secretary of ,health and ,human ,services7 institution of higher education2 and 7,b7 have practiced as a primary care provider for a period 7excluding any residency or fellowship training period7 of not less than #c years in a medically underserved community 7as defined in section #gii;,b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #biep774 7#c7 ,installments ,payments under this section may be made in installments of not more than #be1jjj for each year of service described in paragraph 7#a7 7,a74 7#d7 ,applicability of certain provisions ,the provisions of subpart ,,iii of part ,d of title ,,iii of the ,public ,health ,service ,act shall1 except as inconsistent with this section1 apply to the program established under this section in the same manner and to the same extent as such provisions apply to the ,national ,health ,service ,corps ,loan ,repayment ,program established in such subpart4 7b7 ,permitting ,state designation of critical access hospitals ,section #ahbj7;c77#b77;,b77i77,,ii7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;i-#d7;c77#b77;,b77i77,,ii77 is amended by inserting or on or after the date of enactment of the ,steps ,toward ,access and ,reform ,act of #bjac after ,january #a1 #bjjf14 7c7 ,patient fairness and indigent care promotion 7#a7 ,in ,general ,section #aff of the ,internal ,revenue ,code of #aihf 7relating to bad debts7 is amended by redesignating subsection 7f7 as subsection 7g7 and by inserting after subsection 7e7 the following new subsection3 7f7 ,unpaid ,medical ,care ,provided to ,low-,income ,individuals 7#a7 ,in general ,in the case of a taxpayer to whom this subsection applies1 the deduction under subsection 7a7 for worthless qualified medical care debt shall not be less than #ge percent of the taxpayer's charge for such care4 7#b7 ,taxpayer to whom subsection applies ,this subsection shall apply to any taxpayer who is engaged in the trade or business of providing medical care other than as an employee and who used the cash receipts and disbursements method of accounting4 7#c7 ,qualified medical care debt ,for purposes of this subsection1 the term qualified medical care debt means any debt for medical care provided by the taxpayer to a low-income individual who is a citizen or legal resident of the ,united ,states4 7#d7 ,determination of charge ,the amount of the taxpayer's charge which may be taken into account-- 7,a7 shall not exceed the amount of the charge that would be recognized for purposes of title ,,xviii of the ,social ,security ,act1 and 7,b7 shall not include any amount for which the taxpayer is not entitled to reimbursement from the low-income individual4 7#e7 ,low-income individual ,for purposes of this subsection1 the term low-income individual means an individual who1 at the time the medical care attributable to the debt is provided1 has an annual household income below #ace percent of the poverty line 7as defined in section #fgc of the ,community ,services ,block ,grant ,act 7#db ,u4,s4,c4 #iijb77 applicable to the size of the family involved1 and is a citizen or legal resident of the ,united ,states4 7#f7 ,medical care ,for purposes of this subsection1 the term medical care has the meaning given to such term by section #bac7;d74 7#g7 ,regulations ,the ,secretary shall prescribe such regulations as may be necessary or appropriate to carry out this section1 including regulations providing for methods of establishing that an individual is a low-income individual for purposes of this section4 4 7#b7 ,effective ,date ,the amendment made by this section shall apply to taxable years beginning after the date of the enactment of this ,act4 ,,iii ,,providing ,,for ,,affordable ,,prescription ,,drugs #cja4 ,providing for affordable prescription drugs ,notwithstanding any other provision of law1 the ,food and ,drug ,administration shall not take any action to prevent an individual not in the business of importing a prescription drug 7within the meaning of section #hja7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;g777 from importing a prescription drug from ,canada that complies with the ,federal ,food1 ,drug1 and ,cosmetic ,act4 ,,iv ,expanding ,choices by ,allowing ,americans to ,buy ,health ,care ,coverage ,across ,state ,lines #dja4 ,interstate purchasing of health insurance 7a7 ,in ,general ,title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg et seq47 is amended by adding at the end the following3 ,d ,cooperative ,governing of ,individual ,health ,insurance ,coverage #bgie4 ,definitions ,in this part3 7#a7 ,primary state ,the term primary ,state means1 with respect to individual health insurance coverage offered by a health insurance issuer1 the ,state designated by the issuer as the ,state whose covered laws shall govern the health insurance issuer in the sale of such coverage under this part4 ,an issuer1 with respect to a particular policy1 may only designate one such ,state as its primary ,state with respect to all such coverage it offers4 ,such an issuer may not change the designated primary ,state with respect to individual health insurance coverage once the policy is issued1 except that such a change may be made upon renewal of the policy4 ,with respect to such designated ,state1 the issuer is deemed to be doing business in that ,state4 7#b7 ,secondary state ,the term secondary ,state means1 with respect to individual health insurance coverage offered by a health insurance issuer1 any ,state that is not the primary ,state4 ,in the case of a health insurance issuer that is selling a policy in1 or to a resident of1 a secondary ,state1 the issuer is deemed to be doing business in that secondary ,state4 7#c7 ,health insurance issuer ,the term health insurance issuer has the meaning given such term in section #bgia7;b77#b71 except that such an issuer must be licensed in the primary ,state and be qualified to sell individual health insurance coverage in that ,state4 7#d7 ,individual health insurance coverage ,the term individual health insurance coverage means health insurance coverage offered in the individual market1 as defined in section #bgia7;e77#a74 7#e7 ,applicable state authority ,the term applicable ,state authority means1 with respect to a health insurance issuer in a ,state1 the ,state insurance commissioner or official or officials designated by the ,state to enforce the requirements of this title for the ,state with respect to the issuer4 7#f7 ,hazardous financial condition ,the term hazardous financial condition means that1 based on its present or reasonably anticipated financial condition1 a health insurance issuer is unlikely to be able-- 7,a7 to meet obligations to policyholders with respect to known claims and reasonably anticipated claims2 or 7,b7 to pay other obligations in the normal course of business4 7#g7 ,covered laws 7,a7 ,in general ,the term covered laws means the laws1 rules1 regulations1 agreements1 and orders governing the insurance business pertaining to-- 7i7 individual health insurance coverage issued by a health insurance issuer2 7ii7 the offer1 sale1 rating 7including medical underwriting71 renewal1 and issuance of individual health insurance coverage to an individual2 7iii7 the provision to an individual in relation to individual health insurance coverage of health care and insurance related services2 7iv7 the provision to an individual in relation to individual health insurance coverage of management1 operations1 and investment activities of a health insurance issuer2 and 7v7 the provision to an individual in relation to individual health insurance coverage of loss control and claims administration for a health insurance issuer with respect to liability for which the issuer provides insurance4 7,b7 ,exception ,such term does not include any law1 rule1 regulation1 agreement1 or order governing the use of care or cost management techniques1 including any requirement related to provider contracting1 network access or adequacy1 health care data collection1 or quality assurance4 7#h7 ,state ,the term ,state means the #ej ,states and includes the ,district of ,columbia1 ,puerto ,rico1 the ,virgin ,islands1 ,guam1 ,american ,samoa1 and the ,northern ,mariana ,islands4 7#i7 ,unfair claims settlement practices ,the term unfair claims settlement practices means only the following practices3 7,a7 ,knowingly misrepresenting to claimants and insured individuals relevant facts or policy provisions relating to coverage at issue4 7,b7 ,failing to acknowledge with reasonable promptness pertinent communications with respect to claims arising under policies4 7,c7 ,failing to adopt and implement reasonable standards for the prompt investigation and settlement of claims arising under policies4 7,d7 ,failing to effectuate prompt1 fair1 and equitable settlement of claims submitted in which liability has become reasonably clear4 7,e7 ,refusing to pay claims without conducting a reasonable investigation4 7,f7 ,failing to affirm or deny coverage of claims within a reasonable period of time after having completed an investigation related to those claims4 7,g7 ,a pattern or practice of compelling insured individuals or their beneficiaries to institute suits to recover amounts due under its policies by offering substantially less than the amounts ultimately recovered in suits brought by them4 7,h7 ,a pattern or practice of attempting to settle or settling claims for less than the amount that a reasonable person would believe the insured individual or his or her beneficiary was entitled by reference to written or printed advertising material accompanying or made part of an application4 7,i7 ,attempting to settle or settling claims on the basis of an application that was materially altered without notice to1 or knowledge or consent of1 the insured4 7,j7 ,failing to provide forms necessary to present claims within #ae calendar days of a request with reasonable explanations regarding their use4 7,k7 ,attempting to cancel a policy in less time than that prescribed in the policy or by the law of the primary ,state4 7#aj7 ,fraud and abuse ,the term fraud and abuse means an act or omission committed by a person who1 knowingly and with intent to defraud1 commits1 or conceals any material information concerning1 one or more of the following3 7,a7 ,presenting1 causing to be presented or preparing with knowledge or belief that it will be presented to or by an insurer1 a reinsurer1 broker or its agent1 false information as part of1 in support of or concerning a fact material to one or more of the following3 7i7 ,an application for the issuance or renewal of an insurance policy or reinsurance contract4 7ii7 ,the rating of an insurance policy or reinsurance contract4 7iii7 ,a claim for payment or benefit pursuant to an insurance policy or reinsurance contract4 7iv7 ,premiums paid on an insurance policy or reinsurance contract4 7v7 ,payments made in accordance with the terms of an insurance policy or reinsurance contract4 7vi7 ,a document filed with the commissioner or the chief insurance regulatory official of another jurisdiction4 7vii7 ,the financial condition of an insurer or reinsurer4 7viii7 ,the formation1 acquisition1 merger1 reconsolidation1 dissolution or withdrawal from one or more lines of insurance or reinsurance in all or part of a ,state by an insurer or reinsurer4 7ix7 ,the issuance of written evidence of insurance4 7x7 ,the reinstatement of an insurance policy4 7,b7 ,solicitation or acceptance of new or renewal insurance risks on behalf of an insurer reinsurer or other person engaged in the business of insurance by a person who knows or should know that the insurer or other person responsible for the risk is insolvent at the time of the transaction4 7,c7 ,transaction of the business of insurance in violation of laws requiring a license1 certificate of authority or other legal authority for the transaction of the business of insurance4 7,d7 ,attempt to commit1 aiding or abetting in the commission of1 or conspiracy to commit the acts or omissions specified in this paragraph4 #bgif4 ,application of law 7a7 ,in ,general ,the covered laws of the primary ,state shall apply to individual health insurance coverage offered by a health insurance issuer in the primary ,state and in any secondary ,state1 but only if the coverage and issuer comply with the conditions of this section with respect to the offering of coverage in any secondary ,state4 7b7 ,exemptions ,from ,covered ,laws in a ,secondary ,state ,except as provided in this section1 a health insurance issuer with respect to its offer1 sale1 rating 7including medical underwriting71 renewal1 and issuance of individual health insurance coverage in any secondary ,state is exempt from any covered laws of the secondary ,state 7and any rules1 regulations1 agreements1 or orders sought or issued by such ,state under or related to such covered laws7 to the extent that such laws would-- 7#a7 make unlawful1 or regulate1 directly or indirectly1 the operation of the health insurance issuer operating in the secondary ,state1 except that any secondary ,state may require such an issuer-- 7,a7 to pay1 on a nondiscriminatory basis1 applicable premium and other taxes 7including high risk pool assessments7 which are levied on insurers and surplus lines insurers1 brokers1 or policyholders under the laws of the ,state2 7,b7 to register with and designate the ,state insurance commissioner as its agent solely for the purpose of receiving service of legal documents or process2 7,c7 to submit to an examination of its financial condition by the ,state insurance commissioner in any ,state in which the issuer is doing business to determine the issuer's financial condition1 if-- 7i7 the ,state insurance commissioner of the primary ,state has not done an examination within the period recommended by the ,national ,association of ,insurance ,commissioners2 and 7ii7 any such examination is conducted in accordance with the examiners' handbook of the ,national ,association of ,insurance ,commissioners and is coordinated to avoid unjustified duplication and unjustified repetition2 7,d7 to comply with a lawful order issued-- 7i7 in a delinquency proceeding commenced by the ,state insurance commissioner if there has been a finding of financial impairment under subparagraph 7,c72 or 7ii7 in a voluntary dissolution proceeding2 7,e7 to comply with an injunction issued by a court of competent jurisdiction1 upon a petition by the ,state insurance commissioner alleging that the issuer is in hazardous financial condition2 7,f7 to participate1 on a nondiscriminatory basis1 in any insurance insolvency guaranty association or similar association to which a health insurance issuer in the ,state is required to belong2 7,g7 to comply with any ,state law regarding fraud and abuse 7as defined in section #bgie7aj771 except that if the ,state seeks an injunction regarding the conduct described in this subparagraph1 such injunction must be obtained from a court of competent jurisdiction2 7,h7 to comply with any ,state law regarding unfair claims settlement practices 7as defined in section #bgie7i772 or 7,i7 to comply with the applicable requirements for independent review under section #bgih with respect to coverage offered in the ,state2 7#b7 require any individual health insurance coverage issued by the issuer to be countersigned by an insurance agent or broker residing in that ,secondary ,state2 or 7#c7 otherwise discriminate against the issuer issuing insurance in both the primary ,state and in any secondary ,state4 7c7 ,clear and ,conspicuous ,disclosure ,a health insurance issuer shall provide the following notice1 in #ab-point bold type1 in any insurance coverage offered in a secondary ,state under this part by such a health insurance issuer and at renewal of the policy1 with the #e blank spaces therein being appropriately filled with the name of the health insurance issuer1 the name of primary ,state1 the name of the secondary ,state1 the name of the secondary ,state1 and the name of the secondary ,state1 respectively1 for the coverage concerned3 ,this policy is issued by and is governed by the laws and regulations of the ,state of 1 and it has met all the laws of that ,state as determined by that ,state's ,department of ,insurance4 ,this policy may be less expensive than others because it is not subject to all of the insurance laws and regulations of the ,state of 1 including coverage of some services or benefits mandated by the law of the ,state of 4 ,additionally1 this policy is not subject to all of the consumer protection laws or restrictions on rate changes of the ,state of 4 ,as with all insurance products1 before purchasing this policy1 you should carefully review the policy and determine what health care services the policy covers and what benefits it provides1 including any exclusions1 limitations1 or conditions for such services or benefits4 7d7 ,prohibition on ,certain ,reclassifications and ,premium ,increases 7#a7 ,in general ,for purposes of this section1 a health insurance issuer that provides individual health insurance coverage to an individual under this part in a primary or secondary ,state may not upon renewal-- 7,a7 move or reclassify the individual insured under the health insurance coverage from the class such individual is in at the time of issue of the contract based on the health-status related factors of the individual2 or 7,b7 increase the premiums assessed the individual for such coverage based on a health status-related factor or change of a health status-related factor or the past or prospective claim experience of the insured individual4 7#b7 ,construction ,nothing in paragraph 7#a7 shall be construed to prohibit a health insurance issuer-- 7,a7 from terminating or discontinuing coverage or a class of coverage in accordance with subsections 7b7 and 7c7 of section #bgdb2 7,b7 from raising premium rates for all policy holders within a class based on claims experience2 7,c7 from changing premiums or offering discounted premiums to individuals who engage in wellness activities at intervals prescribed by the issuer1 if such premium changes or incentives-- 7i7 are disclosed to the consumer in the insurance contract2 7ii7 are based on specific wellness activities that are not applicable to all individuals2 and 7iii7 are not obtainable by all individuals to whom coverage is offered2 7,d7 from reinstating lapsed coverage2 or 7,e7 from retroactively adjusting the rates charged an insured individual if the initial rates were set based on material misrepresentation by the individual at the time of issue4 7e7 ,prior ,offering of ,policy in ,primary ,state ,a health insurance issuer may not offer for sale individual health insurance coverage in a secondary ,state unless that coverage is currently offered for sale in the primary ,state4 7f7 ,licensing of ,agents or ,brokers for ,health ,insurance ,issuers ,any ,state may require that a person acting1 or offering to act1 as an agent or broker for a health insurance issuer with respect to the offering of individual health insurance coverage obtain a license from that ,state1 with commissions or other compensation subject to the provisions of the laws of that ,state1 except that a ,state may not impose any qualification or requirement which discriminates against a nonresident agent or broker4 7g7 ,documents for ,submission to ,state ,insurance ,commissioner ,each health insurance issuer issuing individual health insurance coverage in both primary and secondary ,states shall submit-- 7#a7 to the insurance commissioner of each ,state in which it intends to offer such coverage1 before it may offer individual health insurance coverage in such ,state-- 7,a7 a copy of the plan of operation or feasibility study or any similar statement of the policy being offered and its coverage 7which shall include the name of its primary ,state and its principal place of business72 7,b7 written notice of any change in its designation of its primary ,state2 and 7,c7 written notice from the issuer of the issuer's compliance with all the laws of the primary ,state2 and 7#b7 to the insurance commissioner of each secondary ,state in which it offers individual health insurance coverage1 a copy of the issuer's quarterly financial statement submitted to the primary ,state1 which statement shall be certified by an independent public accountant and contain a statement of opinion on loss and loss adjustment expense reserves made by-- 7,a7 a member of the ,american ,academy of ,actuaries2 or 7,b7 a qualified loss reserve specialist4 7h7 ,power of ,courts ,to ,enjoin ,conduct ,nothing in this section shall be construed to affect the authority of any ,federal or ,state court to enjoin-- 7#a7 the solicitation or sale of individual health insurance coverage by a health insurance issuer to any person or group who is not eligible for such insurance2 or 7#b7 the solicitation or sale of individual health insurance coverage that violates the requirements of the law of a secondary ,state which are described in subparagraphs 7,a7 through 7,h7 of section #bgif7;b77#a74 7i7 ,power of ,secondary ,states ,to ,take ,administrative ,action ,nothing in this section shall be construed to affect the authority of any ,state to enjoin conduct in violation of that ,state's laws described in section #bgif7;b77#a74 7j7 ,state ,powers ,to ,enforce ,state ,laws 7#a7 ,in general ,subject to the provisions of subsection 7b77#a77;,g7 7relating to injunctions7 and paragraph 7#b71 nothing in this section shall be construed to affect the authority of any ,state to make use of any of its powers to enforce the laws of such ,state with respect to which a health insurance issuer is not exempt under subsection 7b74 7#b7 ,courts of competent jurisdiction ,if a ,state seeks an injunction regarding the conduct described in paragraphs 7#a7 and 7#b7 of subsection 7h71 such injunction must be obtained from a ,federal or ,state court of competent jurisdiction4 7k7 ,states' ,authority ,to ,sue ,nothing in this section shall affect the authority of any ,state to bring action in any ,federal or ,state court4 7l7 ,generally ,applicable ,laws ,nothing in this section shall be construed to affect the applicability of ,state laws generally applicable to persons or corporations4 7m7 ,guaranteed ,availability of ,coverage to ,,hipaa ,eligible ,individuals ,to the extent that a health insurance issuer is offering coverage in a primary ,state that does not accommodate residents of secondary ,states or does not provide a working mechanism for residents of a secondary ,state1 and the issuer is offering coverage under this part in such secondary ,state which has not adopted a qualified high risk pool as its acceptable alternative mechanism 7as defined in section #bgdd7;c77#b771 the issuer shall1 with respect to any individual health insurance coverage offered in a secondary ,state under this part1 comply with the guaranteed availability requirements for eligible individuals in section #bgda4 #bgig4 ,primary ,state must meet ,federal floor before issuer may sell into secondary ,states ,a health insurance issuer may not offer1 sell1 or issue individual health insurance coverage in a secondary ,state if the ,state insurance commissioner does not use a risk-based capital formula for the determination of capital and surplus requirements for all health insurance issuers4 #bgih4 ,independent external appeals procedures 7a7 ,right to ,external ,appeal ,a health insurance issuer may not offer1 sell1 or issue individual health insurance coverage in a secondary ,state under the provisions of this title unless-- 7#a7 both the secondary ,state and the primary ,state have legislation or regulations in place establishing an independent review process for individuals who are covered by individual health insurance coverage1 or 7#b7 in any case in which the requirements of subparagraph 7,a7 are not met with respect to the either of such ,states1 the issuer provides an independent review mechanism substantially identical 7as determined by the applicable ,state authority of such ,state7 to that prescribed in the ,health ,carrier ,external ,review ,model ,act of the ,national ,association of ,insurance ,commissioners for all individuals who purchase insurance coverage under the terms of this part1 except that1 under such mechanism1 the review is conducted by an independent medical reviewer1 or a panel of such reviewers1 with respect to whom the requirements of subsection 7b7 are met4 7b7 ,qualifications of ,independent ,medical ,reviewers ,in the case of any independent review mechanism referred to in subsection 7a77#b7-- 7#a7 ,in general ,in referring a denial of a claim to an independent medical reviewer1 or to any panel of such reviewers1 to conduct independent medical review1 the issuer shall ensure that-- 7,a7 each independent medical reviewer meets the qualifications described in paragraphs 7#b7 and 7#c72 7,b7 with respect to each review1 each reviewer meets the requirements of paragraph 7#d7 and the reviewer1 or at least #a reviewer on the panel1 meets the requirements described in paragraph 7#e72 and 7,c7 compensation provided by the issuer to each reviewer is consistent with paragraph 7#f74 7#b7 ,licensure and expertise ,each independent medical reviewer shall be a physician 7allopathic or osteopathic7 or health care professional who-- 7,a7 is appropriately credentialed or licensed in #a or more ,states to deliver health care services2 and 7,b7 typically treats the condition1 makes the diagnosis1 or provides the type of treatment under review4 7#c7 ,independence 7,a7 ,in general ,subject to subparagraph 7,b71 each independent medical reviewer in a case shall-- 7i7 not be a related party 7as defined in paragraph 7#g772 7ii7 not have a material familial1 financial1 or professional relationship with such a party2 and 7iii7 not otherwise have a conflict of interest with such a party 7as determined under regulations74 7,b7 ,exception ,nothing in subparagraph 7,a7 shall be construed to-- 7i7 prohibit an individual1 solely on the basis of affiliation with the issuer1 from serving as an independent medical reviewer if-- 7,i7 a non-affiliated individual is not reasonably available2 7,,ii7 the affiliated individual is not involved in the provision of items or services in the case under review2 7,,iii7 the fact of such an affiliation is disclosed to the issuer and the enrollee 7or authorized representative7 and neither party objects2 and 7,,iv7 the affiliated individual is not an employee of the issuer and does not provide services exclusively or primarily to or on behalf of the issuer2 7ii7 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 issuer and the enrollee 7or authorized representative71 and neither party objects2 or 7iii7 prohibit receipt of compensation by an independent medical reviewer from an entity if the compensation is provided consistent with paragraph 7#f74 7#d7 ,practicing health care professional in same field 7,a7 ,in general ,in a case involving treatment1 or the provision of items or services-- 7i7 by a physician1 a reviewer shall be a practicing physician 7allopathic or osteopathic7 of the same or similar specialty1 as a physician who1 acting within the appropriate scope of practice within the ,state in which the service is provided or rendered1 typically treats the condition1 makes the diagnosis1 or provides the type of treatment under review2 or 7ii7 by a non-physician health care professional1 the reviewer1 or at least #a member of the review panel1 shall be a practicing non-physician health care professional of the same or similar specialty as the non-physician health care professional who1 acting within the appropriate scope of practice within the ,state in which the service is provided or rendered1 typically treats the condition1 makes the diagnosis1 or provides the type of treatment under review4 7,b7 ,practicing defined ,for purposes of this paragraph1 the term practicing means1 with respect to an individual who is a physician or other health care professional1 that the individual provides health care services to individual patients on average at least #b days per week4 7#e7 ,pediatric expertise ,in the case of an external review relating to a child1 a reviewer shall have expertise under paragraph 7#b7 in pediatrics4 7#f7 ,limitations on reviewer compensation ,compensation provided by the issuer to an independent medical reviewer in connection with a review under this section shall-- 7,a7 not exceed a reasonable level2 and 7,b7 not be contingent on the decision rendered by the reviewer4 7#g7 ,related party defined ,for purposes of this section1 the term related party means1 with respect to a denial of a claim under a coverage relating to an enrollee1 any of the following3 7,a7 ,the issuer involved1 or any fiduciary1 officer1 director1 or employee of the issuer4 7,b7 ,the enrollee 7or authorized representative74 7,c7 ,the health care professional that provides the items or services involved in the denial4 7,d7 ,the institution at which the items or services 7or treatment7 involved in the denial are provided4 7,e7 ,the manufacturer of any drug or other item that is included in the items or services involved in the denial4 7,f7 ,any other party determined under any regulations to have a substantial interest in the denial involved4 7#h7 ,definitions ,for purposes of this subsection3 7,a7 ,enrollee ,the term enrollee means1 with respect to health insurance coverage offered by a health insurance issuer1 an individual enrolled with the issuer to receive such coverage4 7,b7 ,health care professional ,the term health care professional means an individual who is licensed1 accredited1 or certified under ,state law to provide specified health care services and who is operating within the scope of such licensure1 accreditation1 or certification4 #bgii4 ,enforcement 7a7 ,in ,general ,subject to subsection 7b71 with respect to specific individual health insurance coverage the primary ,state for such coverage has sole jurisdiction to enforce the primary ,state's covered laws in the primary ,state and any secondary ,state4 7b7 ,secondary ,state's ,authority ,nothing in subsection 7a7 shall be construed to affect the authority of a secondary ,state to enforce its laws as set forth in the exception specified in section #bgif7;b77#a74 7c7 ,court ,interpretation ,in reviewing action initiated by the applicable secondary ,state authority1 the court of competent jurisdiction shall apply the covered laws of the primary ,state4 7d7 ,notice of ,compliance ,failure ,in the case of individual health insurance coverage offered in a secondary ,state that fails to comply with the covered laws of the primary ,state1 the applicable ,state authority of the secondary ,state may notify the applicable ,state authority of the primary ,state4 4 7b7 ,effective ,date ,the amendment made by subsection 7a7 shall apply to individual health insurance coverage offered1 issued1 or sold after the date that is one year after the date of the enactment of this ,act4 7c7 ,,gao ,ongoing ,study and ,reports 7#a7 ,study ,the ,comptroller ,general of the ,united ,states shall conduct an ongoing study concerning the effect of the amendment made by subsection 7a7 on-- 7,a7 the number of uninsured and under-insured2 7,b7 the availability and cost of health insurance policies for individuals with preexisting medical conditions2 7,c7 the availability and cost of health insurance policies generally2 7,d7 the elimination or reduction of different types of benefits under health insurance policies offered in different ,states2 and 7,e7 cases of fraud or abuse relating to health insurance coverage offered under such amendment and the resolution of such cases4 7#b7 ,annual reports ,the ,comptroller ,general shall submit to ,congress an annual report1 after the end of each of the #e years following the effective date of the amendment made by subsection 7a71 on the ongoing study conducted under paragraph 7#a74