[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1845 Enrolled Bill (ENR)]

        H.R.1845

                      One Hundred Twelfth Congress

                                 of the

                        United States of America


                          AT THE SECOND SESSION

          Begun and held at the City of Washington on Tuesday,
            the third day of January, two thousand and twelve


                                 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.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.