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[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1845 Engrossed in House (EH)]

112th CONGRESS
  2d Session
                                H. R. 1845

_______________________________________________________________________

                                 AN ACT

 
 To provide a demonstration project providing Medicare coverage for in-
home administration of intravenous immune globulin (IVIG) and to amend 
title XVIII of the Social Security Act with respect to the application 
         of Medicare secondary payer rules for certain claims.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Medicare IVIG Access and 
Strengthening Medicare and Repaying Taxpayers Act of 2012''.

                     TITLE I--MEDICARE IVIG ACCESS

SEC. 101. MEDICARE PATIENT IVIG ACCESS DEMONSTRATION PROJECT.

    (a) Establishment.--The Secretary shall establish and implement a 
demonstration project under part B of title XVIII of the Social 
Security Act to evaluate the benefits of providing payment for items 
and services needed for the in-home administration of intravenous 
immune globin for the treatment of primary immune deficiency diseases.
    (b) Duration and Scope.--
            (1) Duration.--Beginning not later than one year after the 
        date of enactment of this Act, the Secretary shall conduct the 
        demonstration project for a period of 3 years.
            (2) Scope.--The Secretary shall enroll not more than 4,000 
        Medicare beneficiaries who have been diagnosed with primary 
        immunodeficiency disease for participation in the demonstration 
        project. A Medicare beneficiary may participate in the 
        demonstration project on a voluntary basis and may terminate 
        participation at any time.
    (c) Coverage.--Except as otherwise provided in this section, items 
and services for which payment may be made under the demonstration 
program shall be treated and covered under part B of title XVIII of the 
Social Security Act in the same manner as similar items and services 
covered under such part.
    (d) Payment.--The Secretary shall establish a per visit payment 
amount for items and services needed for the in-home administration of 
intravenous immune globin based on the national per visit low-
utilization payment amount under the prospective payment system for 
home health services established under section 1895 of the Social 
Security Act (42 U.S.C. 1395fff).
    (e) Waiver Authority.--The Secretary may waive such requirements of 
title XVIII of the Social Security Act as may be necessary to carry out 
the demonstration project.
    (f) Study and Report to Congress.--
            (1) Interim evaluation and report.--Not later than three 
        years after the date of enactment of this Act, the Secretary 
        shall submit to Congress a report that contains an interim 
        evaluation of the impact of the demonstration project on access 
        for Medicare beneficiaries to items and services needed for the 
        in-home administration of intravenous immune globin.
            (2) Final evaluation and report.--Not later than one year 
        after the date of completion of the demonstration project, the 
        Secretary shall submit to Congress a report that contains the 
        following:
                    (A) A final evaluation of the impact of the 
                demonstration project on access for Medicare 
                beneficiaries to items and services needed for the in-
                home administration of intravenous immune globin.
                    (B) An analysis of the appropriateness of 
                implementing a new methodology for payment for 
                intravenous immune globulins in all care settings under 
                part B of title XVIII of the Social Security Act (42 
                U.S.C. 1395k et seq.).
                    (C) An update to the report entitled ``Analysis of 
                Supply, Distribution, Demand, and Access Issues 
                Associated with Immune Globulin Intravenous (IGIV)'', 
                issued in February 2007 by the Office of the Assistant 
                Secretary for Planning and Evaluation of the Department 
                of Health and Human Services.
    (g) Funding.--There shall be made available to the Secretary to 
carry out the demonstration project not more than $45,000,000 from the 
Federal Supplementary Medical Insurance Trust Fund under section 1841 
of the Social Security Act (42 U.S.C. 1395t).
    (h) Definitions.--In this section:
            (1) Demonstration project.--The term ``demonstration 
        project'' means the demonstration project conducted under this 
        section.
            (2) Medicare beneficiary.--The term ``Medicare 
        beneficiary'' means an individual who is enrolled for benefits 
        under part B of title XVIII of the Social Security Act.
            (3) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.

         TITLE II--STRENGTHENING MEDICARE SECONDARY PAYER RULES

SEC. 201. DETERMINATION OF REIMBURSEMENT AMOUNT THROUGH CMS WEBSITE TO 
              IMPROVE PROGRAM EFFICIENCY.

    Section 1862(b)(2)(B) of the Social Security Act (42 U.S.C. 
1395y(b)(2)(B)) is amended by adding at the end the following new 
clause:
                            ``(vii) Use of website to determine final 
                        conditional reimbursement amount.--
                                    ``(I) Notice to secretary of 
                                expected date of a settlement, 
                                judgment, etc.--In the case of a 
                                payment made by the Secretary pursuant 
                                to clause (i) for items and services 
                                provided to the claimant, the claimant 
                                or applicable plan (as defined in 
                                paragraph (8)(F)) may at any time 
                                beginning 120 days before the 
                                reasonably expected date of a 
                                settlement, judgment, award, or other 
                                payment, notify the Secretary that a 
                                payment is reasonably expected and the 
                                expected date of such payment.
                                    ``(II) Secretarial providing access 
                                to claims information through a 
                                website.--The Secretary shall maintain 
                                and make available to individuals to 
                                whom items and services are furnished 
                                under this title (and to authorized 
                                family or other representatives 
                                recognized under regulations and to an 
                                applicable plan which has obtained the 
                                consent of the individual) access to 
                                information on the claims for such 
                                items and services (including payment 
                                amounts for such claims), including 
                                those claims that relate to a potential 
                                settlement, judgment, award, or other 
                                payment . Such access shall be provided 
                                to an individual, representative, or 
                                plan through a website that requires a 
                                password to gain access to the 
                                information. The Secretary shall update 
                                the information on claims and payments 
                                on such website in as timely a manner 
                                as possible but not later than 15 days 
                                after the date that payment is made. 
                                Information related to claims and 
                                payments subject to the notice under 
                                subclause (I) shall be maintained and 
                                made available consistent with the 
                                following:
                                            ``(aa) The information 
                                        shall be as complete as 
                                        possible and shall include 
                                        provider or supplier name, 
                                        diagnosis codes (if any), dates 
                                        of service, and conditional 
                                        payment amounts.
                                            ``(bb) The information 
                                        accurately identifies those 
                                        claims and payments that are 
                                        related to a potential 
                                        settlement, judgment, award, or 
                                        other payment to which the 
                                        provisions of this subsection 
                                        apply.
                                            ``(cc) The website provides 
                                        a method for the receipt of 
                                        secure electronic 
                                        communications with the 
                                        individual, representative, or 
                                        plan involved.
                                            ``(dd) The website provides 
                                        that information is transmitted 
                                        from the website in a form that 
                                        includes an official time and 
                                        date that the information is 
                                        transmitted.
                                            ``(ee) The website shall 
                                        permit the individual, 
                                        representative, or plan to 
                                        download a statement of 
                                        reimbursement amounts (in this 
                                        clause referred to as a 
                                        `statement of reimbursement 
                                        amount') on payments for claims 
                                        under this title relating to a 
                                        potential settlement, judgment, 
                                        award, or other payment.
                                    ``(III) Use of timely web download 
                                as basis for final conditional 
                                amount.--If an individual (or other 
                                claimant or applicable plan with the 
                                consent of the individual) obtains a 
                                statement of reimbursement amount from 
                                the website during the protected period 
                                as defined in subclause (V) and the 
                                related settlement, judgment, award or 
                                other payment is made during such 
                                period, then the last statement of 
                                reimbursement amount that is downloaded 
                                during such period and within 3 
                                business days before the date of the 
                                settlement, judgment, award, or other 
                                payment shall constitute the final 
                                conditional amount subject to recovery 
                                under clause (ii) related to such 
                                settlement, judgment, award, or other 
                                payment.
                                    ``(IV) Resolution of 
                                discrepancies.--If the individual (or 
                                authorized representative) believes 
                                there is a discrepancy with the 
                                statement of reimbursement amount, the 
                                Secretary shall provide a timely 
                                process to resolve the discrepancy. 
                                Under such process the individual (or 
                                representative) must provide 
                                documentation explaining the 
                                discrepancy and a proposal to resolve 
                                such discrepancy. Within 11 business 
                                days after the date of receipt of such 
                                documentation, the Secretary shall 
                                determine whether there is a reasonable 
                                basis to include or remove claims on 
                                the statement of reimbursement. If the 
                                Secretary does not make such 
                                determination within the 11 business-
                                day period, then the proposal to 
                                resolve the discrepancy shall be 
                                accepted. If the Secretary determines 
                                within such period that there is not a 
                                reasonable basis to include or remove 
                                claims on the statement of 
                                reimbursement, the proposal shall be 
                                rejected. If the Secretary determines 
                                within such period that there is a 
                                reasonable basis to conclude there is a 
                                discrepancy, the Secretary must respond 
                                in a timely manner by agreeing to the 
                                proposal to resolve the discrepancy or 
                                by providing documentation showing with 
                                good cause why the Secretary is not 
                                agreeing to such proposal and 
                                establishing an alternate discrepancy 
                                resolution. In no case shall the 
                                process under this subclause be treated 
                                as an appeals process or as 
                                establishing a right of appeal for a 
                                statement of reimbursement amount and 
                                there shall be no administrative or 
                                judicial review of the Secretary's 
                                determinations under this subclause.
                                    ``(V) Protected period.--In 
                                subclause (III), the term `protected 
                                period' means, with respect to a 
                                settlement, judgment, award or other 
                                payment relating to an injury or 
                                incident, the portion (if any) of the 
                                period beginning on the date of notice 
                                under subclause (I) with respect to 
                                such settlement, judgment, award, or 
                                other payment that is after the end of 
                                a Secretarial response period beginning 
                                on the date of such notice to the 
                                Secretary. Such Secretarial response 
                                period shall be a period of 65 days, 
                                except that such period may be extended 
                                by the Secretary for a period of an 
                                additional 30 days if the Secretary 
                                determines that additional time is 
                                required to address claims for which 
                                payment has been made. Such Secretarial 
                                response period shall be extended and 
                                shall not include any days for any part 
                                of which the Secretary determines (in 
                                accordance with regulations) that there 
                                was a failure in the claims and payment 
                                posting system and the failure was 
                                justified due to exceptional 
                                circumstances (as defined in such 
                                regulations). Such regulations shall 
                                define exceptional circumstances in a 
                                manner so that not more than 1 percent 
                                of the repayment obligations under this 
                                subclause would qualify as exceptional 
                                circumstances.
                                    ``(VI) Effective date.--The 
                                Secretary shall promulgate final 
                                regulations to carry out this clause 
                                not later than 9 months after the date 
                                of the enactment of this clause.
                                    ``(VII) Website including successor 
                                technology.--In this clause, the term 
                                `website' includes any successor 
                                technology.
                            ``(viii) Right of appeal for secondary 
                        payer determinations relating to liability 
                        insurance (including self-insurance), no fault 
                        insurance, and workers' compensation laws and 
                        plans.--The Secretary shall promulgate 
                        regulations establishing a right of appeal and 
                        appeals process, with respect to any 
                        determination under this subsection for a 
                        payment made under this title for an item or 
                        service for which the Secretary is seeking to 
                        recover conditional payments from an applicable 
                        plan (as defined in paragraph (8)(F)) that is a 
                        primary plan under subsection (A)(ii), under 
                        which the applicable plan involved, or an 
                        attorney, agent, or third party administrator 
                        on behalf of such plan, may appeal such 
                        determination. The individual furnished such an 
                        item or service shall be notified of the plan's 
                        intent to appeal such determination''.

SEC. 202. FISCAL EFFICIENCY AND REVENUE NEUTRALITY.

    (a) In General.--Section 1862(b) of the Social Security Act (42 
U.S.C. 1395y(b)) is amended--
            (1) in paragraph (2)(B)(ii), by striking ``A primary plan'' 
        and inserting ``Subject to paragraph (9), a primary plan''; and
            (2) by adding at the end the following new paragraph:
            ``(9) Exception.--
                    ``(A) In general.--Clause (ii) of paragraph (2)(B) 
                and any reporting required by paragraph (8) shall not 
                apply with respect to any settlement, judgment, award, 
                or other payment by an applicable plan arising from 
                liability insurance (including self-insurance) and from 
                alleged physical trauma-based incidents (excluding 
                alleged ingestion, implantation, or exposure cases) 
                constituting a total payment obligation to a claimant 
                of not more than the single threshold amount calculated 
                by the Secretary under subparagraph (B) for the year 
                involved.
                    ``(B) Annual computation of threshold.--
                            ``(i) In general.--Not later than November 
                        15 before each year, the Secretary shall 
                        calculate and publish a single threshold amount 
                        for settlements, judgments, awards, or other 
                        payments for obligations arising from liability 
                        insurance (including self-insurance) and for 
                        alleged physical trauma-based incidents 
                        (excluding alleged ingestion, implantation, or 
                        exposure cases) subject to this section for 
                        that year. The annual single threshold amount 
                        for a year shall be set such that the estimated 
                        average amount to be credited to the Medicare 
                        trust funds of collections of conditional 
                        payments from such settlements, judgments, 
                        awards, or other payments arising from 
                        liability insurance (including self-insurance) 
                        and for such alleged incidents subject to this 
                        section shall equal the estimated cost of 
                        collection incurred by the United States 
                        (including payments made to contractors) for a 
                        conditional payment arising from liability 
                        insurance (including self-insurance) and for 
                        such alleged incidents subject to this section 
                        for the year. At the time of calculating, but 
                        before publishing, the single threshold amount 
                        for a year, the Secretary shall inform, and 
                        seek review of, the Comptroller General of the 
                        United States with regard to such amount.
                            ``(ii) Publication.-- The Secretary shall 
                        include, as part of such publication for a 
                        year--
                                    ``(I) the estimated cost of 
                                collection incurred by the United 
                                States (including payments made to 
                                contractors) for a conditional payment 
                                arising from liability insurance 
                                (including self-insurance) and for such 
                                alleged incidents; and
                                    ``(II) a summary of the methodology 
                                and data used by the Secretary in 
                                computing such threshold amount and 
                                such cost of collection.
                    ``(C) Exclusion of ongoing expenses.--For purposes 
                of this paragraph and with respect to a settlement, 
                judgment, award, or other payment not otherwise 
                addressed in clause (ii) of paragraph (2)(B) that 
                includes ongoing responsibility for medical payments 
                (excluding settlements, judgments, awards, or other 
                payments made by a workers' compensation law or plan or 
                no fault insurance), the amount utilized for 
                calculation of the threshold described in subparagraph 
                (A) shall include only the cumulative value of the 
                medical payments made under this title.
                    ``(D) Report to congress.--Not later than November 
                15 before each year, the Secretary shall submit to the 
                Congress a report on the single threshold amount for 
                settlements, judgments, awards, or other payments for 
                conditional payment obligations arising from liability 
                insurance (including self-insurance) and alleged 
                incidents described in subparagraph (A) for that year 
                and on the establishment and application of similar 
                thresholds for such payments for conditional payment 
                obligations arising from worker compensation cases and 
                from no fault insurance cases subject to this section 
                for the year. For each such report, the Secretary 
                shall--
                            ``(i) calculate the threshold amount by 
                        using the methodology applicable to certain 
                        liability claims described in subparagraph (B); 
                        and
                            ``(ii) include a summary of the methodology 
                        and data used in calculating each threshold 
                        amount and the amount of estimated savings 
                        under this title achieved by the Secretary 
                        implementing each such threshold.''.
    (b) Effective Date.--The amendments made by subsection (a) shall 
apply to years beginning with 2014.

SEC. 203. REPORTING REQUIREMENT.

    Section 1862(b)(8) of the Social Security Act (42 U.S.C. 
1395y(b)(8)) is amended--
            (1) in the first sentence of subparagraph (E)(i), by 
        striking ``shall be subject'' and all that follows through the 
        end of the sentence and inserting the following: ``may be 
        subject to a civil money penalty of up to $1,000 for each day 
        of noncompliance with respect to each claimant.''; and
            (2) by adding at the end the following new subparagraph:
                    ``(I) Regulations.--Not later than 60 days after 
                the date of the enactment of this subparagraph, the 
                Secretary shall publish a notice in the Federal 
                Register soliciting proposals, which will be accepted 
                during a 60-day period, for the specification of 
                practices for which sanctions will and will not be 
                imposed under subparagraph (E), including not imposing 
                sanctions for good faith efforts to identify a 
                beneficiary pursuant to this paragraph under an 
                applicable entity responsible for reporting 
                information. After considering the proposals so 
                submitted, the Secretary, in consultation with the 
                Attorney General, shall publish in the Federal 
                Register, including a 60-day period for comment, 
                proposed specified practices for which such sanctions 
                will and will not be imposed. After considering any 
                public comments received during such period, the 
                Secretary shall issue final rules specifying such 
                practices.''.

SEC. 204. USE OF SOCIAL SECURITY NUMBERS AND OTHER IDENTIFYING 
              INFORMATION IN REPORTING.

    Section 1862(b)(8)(B) of the Social Security Act (42 U.S.C. 
1395y(b)(8)(B)) is amended by adding at the end (after and below clause 
(ii)) the following:
                ``Not later than 18 months after the date of enactment 
                of this sentence, the Secretary shall modify the 
                reporting requirements under this paragraph so that an 
                applicable plan in complying with such requirements is 
                permitted but not required to access or report to the 
                Secretary beneficiary social security account numbers 
                or health identification claim numbers, except that the 
                deadline for such modification shall be extended by one 
                or more periods (specified by the Secretary) of up to 1 
                year each if the Secretary notifies the committees of 
                jurisdiction of the House of Representatives and of the 
                Senate that the prior deadline for such modification, 
                without such extension, threatens patient privacy or 
                the integrity of the secondary payer program under this 
                subsection. Any such deadline extension notice shall 
                include information on the progress being made in 
                implementing such modification and the anticipated 
                implementation date for such modification.''.

SEC. 205. STATUTE OF LIMITATIONS.

    (a) In General.--Section 1862(b)(2)(B)(iii) of the Social Security 
Act (42 U.S.C. 1395y(b)(2)(B)(iii)) is amended by adding at the end the 
following new sentence: ``An action may not be brought by the United 
States under this clause with respect to payment owed unless the 
complaint is filed not later than 3 years after the date of the receipt 
of notice of a settlement, judgment, award, or other payment made 
pursuant to paragraph (8) relating to such payment owed.''.
    (b) Effective Date.--The amendment made by subsection (a) shall 
apply with respect to actions brought and penalties sought on or after 
6 months after the date of the enactment of this Act.

            Passed the House of Representatives December 19, 2012.

            Attest:

                                                                 Clerk.
112th CONGRESS

  2d Session

                               H. R. 1845

_______________________________________________________________________

                                 AN ACT

 To provide a demonstration project providing Medicare coverage for in-
home administration of intravenous immune globulin (IVIG) and to amend 
title XVIII of the Social Security Act with respect to the application 
         of Medicare secondary payer rules for certain claims.
```