[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.