In this task, you are given text for US Congressional and California state bills, your task is to generate a summary for this bill.
One example is below.
Q: SECTION 1. LIABILITY OF BUSINESS ENTITIES PROVIDING USE OF FACILITIES
TO NONPROFIT ORGANIZATIONS.

(a) Definitions.--In this section:
(1) Business entity.--The term ''business entity'' means a
firm, corporation, association, partnership, consortium, joint
venture, or other form of enterprise.
(2) Facility.--The term ''facility'' means any real
property, including any building, improvement, or appurtenance.
(3) Gross negligence.--The term ''gross negligence'' means
voluntary and conscious conduct by a person with knowledge (at
the time of the conduct) that the conduct is likely to be
harmful to the health or well-being of another person.
(4) Intentional misconduct.--The term ''intentional
misconduct'' means conduct by a person with knowledge (at the
time of the conduct) that the conduct is harmful to the health
or well-being of another person.
(5) Nonprofit organization.--The term ''nonprofit
organization'' means--
(A) any organization described in section 501(c)(3)
of the Internal Revenue Code of 1986 and exempt from
tax under section 501(a) of such Code; or
(B) any not-for-profit organization organized and
conducted for public benefit and operated primarily for
charitable, civic, educational, religious, welfare, or
health purposes.
(6) State.--The term ''State'' means each of the several
States, the District of Columbia, the Commonwealth of Puerto
Rico, the Virgin Islands, Guam, American Samoa, the Northern
Mariana Islands, any other territory or possession of the
United States, or any political subdivision of any such State,
territory, or possession.
(b) Limitation on Liability.--
(1) In general.--Subject to subsection (c), a business
entity shall not be subject to civil liability relating to any
injury or death occurring at a facility of the business entity
in connection with a use of such facility by a nonprofit
organization if--
(A) the use occurs outside of the scope of business
of the business entity;
(B) such injury or death occurs during a period
that such facility is used by the nonprofit
organization; and
(C) the business entity authorized the use of such
facility by the nonprofit organization.
(2) Application.--This subsection shall apply--
(A) with respect to civil liability under Federal
and State law; and
(B) regardless of whether a nonprofit organization
pays for the use of a facility.
(c) Exception for Liability.--Subsection (b) shall not apply to an
injury or death that results from an act or omission of a business
entity that constitutes gross negligence or intentional misconduct,
including any misconduct that--
(1) constitutes a crime of violence (as that term is
defined in section 16 of title 18, United States Code) or act
of international terrorism (as that term is defined in section
2331 of title 18) for which the defendant has been convicted in
any court;
(2) constitutes a hate crime (as that term is used in the
Hate Crime Statistics Act (28 U.S.C. 534 note));
(3) involves a sexual offense, as defined by applicable
State law, for which the defendant has been convicted in any
court; or
(4) involves misconduct for which the defendant has been
found to have violated a Federal or State civil rights law.
(d) Superseding Provision.--
(1) In general.--Subject to paragraph (2) and subsection
(e), this Act preempts the laws of any State to the extent that
such laws are inconsistent with this Act, except that this Act
shall not preempt any State law that provides additional
protection from liability for a business entity for an injury
or death with respect to which conditions under subparagraphs
(A) through (C) of subsection (b)(1) apply.
(2) Limitation.--Nothing in this Act shall be construed to
supersede any Federal or State health or safety law.
(e) Election of State Regarding Nonapplicability.--This Act shall
not apply to any civil action in a State court against a business
entity in which all parties are citizens of the State if such State
enacts a statute--
(1) citing the authority of this subsection;
(2) declaring the election of such State that this Act
shall not apply to such civil action in the State; and
(3) containing no other provision.
A: Shields a business entity from civil liability relating to any injury or death occurring at a facility of that entity in connection with a use of such facility by a nonprofit organization if: (1) the use occurs outside the scope of business of the business entity; (2) such injury or death occurs during a period that such facility is used by such organization; and (3) the business entity authorized the use of such facility by the organization.
Makes this Act inapplicable to an injury or death that results from an act or omission of a business entity that constitutes gross negligence or intentional misconduct, including misconduct that: (1) constitutes a hate crime or a crime of violence or act of international terrorism for which the defendant has been convicted in any court; or (2) involves a sexual offense for which the defendant has been convicted in any court or misconduct for which the defendant has been found to have violated a Federal or State civil rights law.
Preempts State laws to the extent that such laws are inconsistent with this Act, except State law that provides additional protection from liability. Specifies that this Act shall not be construed to supersede any Federal or State health or safety law.
Makes this Act inapplicable to any civil action in a State court against a business entity in which all parties are citizens of the State if such State, citing this Act's authority and containing no other provision, enacts a statute declaring the State's election that this Act shall not apply to such action in the State.
Rationale: This Bill focuses on shielding business entities from civil liability relating to an injury or death depending on the conditions of injury, hence the generated summary is correct.
Q: SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) Short Title.--This Act may be cited as the ''Medicare IVIG
Access Act of 2007''.
(b) Table of Contents.--The table of contents of this Act is as
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Medicare payment for immune globulins.
Sec. 4. Coverage and payment of intravenous immune globulin in the
home.
Sec. 5. Patient access surveys and reports.

SEC. 2. FINDINGS.

(a) Findings.--Congress finds the following:
(1) Intravenous immune globulin (IVIG) is a human blood
plasma derived product, which over the past 25 years has become
an invaluable therapy for many primary immunodeficiency
diseases, as well as a number of neurological, autoimmune, and
other chronic conditions and illnesses. For many of these
disorders, IVIG is the most effective and viable treatment
available, and has dramatically improved the quality of life
for persons with these conditions and has become a life-saving
therapy for many.
(2) The Food and Drug Administration (FDA) recognizes each
IVIG brand as a unique biologic. The differences in basic
fractionation and the addition of various modifications for
further purification, stabilization and virus inactivation/
removal yield clearly different biological products. As a
result, IVIG therapies are not interchangeable, with patient
tolerance differing from one IVIG brand to another.
(3) The report of the Office of the Assistant Secretary for
Planning and Evaluation (ASPE), Department of Health and Human
Services (DHHS), ''Analysis of Supply, Distribution, Demand,
and Access Issues Associated with Immune Globulin Intravenous
(IGIV)'', issued in May 2007, found that IVIG manufacturing is
complex and requires substantial upfront cash outlay and
planning and takes between seven and 12 months from plasma
collection at donor centers to FDA lot release.
(4) The Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 changed Medicare's reimbursement
methodology for IVIG from average wholesale price (AWP) to
average sales price plus 6 percent (ASP+6), effective January
1, 2005, for physicians, and January 1, 2006, for hospital
outpatient departments, thereby reducing reimbursement rates
paid to these providers of IVIG on behalf of Medicare
beneficiaries.
(5) An Office of the Inspector General (OIG) April 2007
report, Intravenous Immune Globulin: Medicare Payment and
Availability, found that Medicare reimbursement for IVIG was
inadequate to cover the cost many providers must pay for the
product. During the third quarter of 2006, 44 percent of IVIG
sales to hospitals and 41 percent of sales to physicians by the
three largest distributors occurred at prices above Medicare
payment amounts.
(6) The ASPE report notes that after the new reimbursement
rules for physicians was instituted in 2005, 42 percent of
Medicare beneficiaries who had received their IVIG treatment in
their physician's office at the end of 2004 were shifted to the
hospital outpatient setting by the beginning of 2006. This
shift in site of care has resulted in lack of continuity of
care and adverse impact on health outcomes and quality of life.
(7) The OIG also reported that 61 percent of responding
physicians indicated that they had sent patients to hospitals
for IVIG treatment, largely because of their inability to
purchase IVIG at prices below the Medicare payment amounts. In
addition, OIG found that some physicians had stopped providing
IVIG to Medicare beneficiaries altogether.
(8) The OIG's 2007 report concluded that whatever
improvement some providers saw in the relationship of Medicare
reimbursement for IVIG to prices paid during the first three
quarters of 2006 would be eroded if manufacturers were to
increase prices for IVIG in the future.
(9) The Centers for Medicare & Medicaid Services, in
recognition of dislocations experienced by patients and
providers in obtaining IVIG since the change to the ASP+6
reimbursement methodology, has provided during 2006 and 2007 a
temporary additional payment for IVIG preadministration-related
services to compensate physicians and hospital outpatient
departments for the extra resources they have had to expend in
locating and obtaining appropriate IVIG products and in
scheduling patient infusions.
(10) Approximately 10,000 Medicare beneficiaries receive
IVIG treatment for their primary immunodeficiency disease in a
variety of different settings. They have no other effective
treatment for their condition.
(11) The Medicare Modernization Act of 2003 (MMA)
established an IVIG home infusion benefit for persons with
primary immunodeficiency disease (PIDD), paying only for IVIG
and specifically excluding coverage of items and services
related to administration of the product.
(12) The ASPE report, Analysis of Supply, Distribution,
Demand, and Access Issues Associated with Immune Globulin
Intravenous (IGIV), found that Medicare's IVIG home infusion
benefit is not designed to reimburse for more than the cost of
IVIG and does not cover the cost of infusion services (for
example, nursing and clinical services and supplies) in the
home. As a consequence, the report found that home infusion
providers generally do not accept new PIDD patients with only
Medicare coverage. These limitations in service are caused by
health care providers (A) not being able to acquire IVIG at
prices at or below the Medicare part B reimbursement level, and
(B) not being reimbursed for the infusion services provided by
a nurse.
(13) Access to home infusion of IVIG for PIDD patients, who
have a genetic or intrinsic defect in their human immune
system, will reduce their exposure to infections at a time when
their antibodies are compromised and will improve the quality
of their care and their health.

SEC. 3. MEDICARE PAYMENT FOR IMMUNE GLOBULINS.

(a) In General.--Section 1842(o)(1)(E) of the Social Security Act
(42 U.S.C. 1395u(o)(1)(E)) is amended--
(1) in paragraph (1)(E)(ii), by inserting before the period
the following: '', plus an additional amount (if applicable)
under paragraph (7)'';
(2) in paragraph (7), by striking ''(6)'' and inserting
''(7)'' and by redesignating it as paragraph (8); and
(3) by inserting after paragraph (6) the following new
paragraph:
''(7)(A) Not later than 6 months after the date of the
enactment of the Medicare IVIG Access Act of 2007, the
Secretary shall--
''(i) collect data on the differences, if any,
between payments to physicians for immune globulins
under paragraph (1)(E)(ii) and costs incurred by
physicians for furnishing these products; and
''(ii) review available data, including survey data
presented by members of the IVIG community on the
access of individuals eligible for services under this
part to immune globulins.
''(B) Upon completion of the review and collection of data
under subparagraph (A), and not later than 7 months after the
date of the enactment of this paragraph, the Secretary shall
provide, if appropriate, to physicians furnishing immune
globulins, a payment, in addition to the payment provided for
in paragraph (1)(E)(ii), for all items related to the
furnishing of immune globulins, in an amount that the Secretary
determines to be appropriate.
''(C) In the case of immune globulins furnished on or after
January 1, 2007, the Secretary shall continue the
preadministration-related services payment established under
the Final Physician Fee Schedule Rule issued by the Centers for
Medicare & Medicaid Services on November 1, 2006 (CMS-1321-FC),
until such time as the Secretary determines that payment for
immune globulins is adequate or until a new payment methodology
is implemented.''.
(b) As Part of Hospital Outpatient Services.--Section 1833(t)(14)
of such Act (42 U.S.C. 1395l(t)(14)) is amended--
(1) in subparagraph (A)(iii), by striking ''subparagraph
(E)'' and inserting ''subparagraphs (E) and (I)''; and
(2) by adding at the end the following new subparagraph:
''(I) Additional payment for immune globulins.--
''(i) Data collection and review.--Not
later than 6 months after the date of the
enactment of the Medicare IVIG Access Act of
2007, the Secretary shall--
''(I) review available data,
including survey data presented by
members of the IVIG community, on the
access of individuals eligible for
services under this part to immune
globulins; and
''(II) collect data on the
differences, if any, between payments
for immune globulins under subparagraph
(A)(iii) and costs incurred for
furnishing these products.
''(ii) Additional payment authority.--Upon
completion of the review and collection of data
under clause (i), and not later than 7 months
after the date of the enactment of this
subparagraph, the Secretary shall provide, if
appropriate, to hospitals furnishing immune
globulins as part of a covered OPD service, a
payment, in addition to the payment provided
for under subparagraph (A)(iii), for all items
related to the furnishing of immune globulins,
in an amount that the Secretary determines to
be appropriate.
''(iii) Continuation of special payment
rule.--In the case of immune globulins
furnished on or after January 1, 2007, the
Secretary shall continue the preadministration-
related services payment established under the
Final Hospital Outpatient Rule issued by the
Centers for Medicare & Medicaid Services
November 1, 2006 (CMS-1506-FC), until such time
as the Secretary determines that payment for
immune globulins is adequate or until a new
payment methodology is implemented.''.

SEC. 4. COVERAGE AND PAYMENT OF INTRAVENOUS IMMUNE GLOBULIN IN THE
HOME.

(a) Including Coverage of Administration.--
(1) In general.--Section 1861 of the Social Security Act
(42 U.S.C. 1395x) is amended--
(A) in subsection (s)(2)(Z), by inserting before
the semicolon at the end the following: '', regardless
of whether the individual receiving the globulin is
eligible to receive home health services under this
title''; and
(B) in subsection (zz), by striking ''but not
including items or services related to the
administration of the derivative''.
(2) Conforming home health amendment.--Section 1814(a) of
such Act (42 U.S.C. 1395f(a)) is amended by adding at the end
the following: ''An individual eligible for intravenous immune
globulin under section 1861(s)(2)(Z) shall not be considered
eligible for home health services under paragraph (2)(C) or
section 1835(a)(2)(A) solely on the basis of meeting the
requirements of such subsection or section 1861(zz).''.
(b) Payment for Intravenous Immune Globulin Administration in the
Home.--Section 1834 of such Act (42 U.S.C. 1395m) is amended by adding
at the end the following new subsection:
''(n) Payment for Intravenous Immune Globulin in the Home.--The
Secretary shall review available published and unpublished data and
information, including the Study of Intravenous Immune Globulin
Administration Options: Safety, Access, and Cost Issues (CMS Contract
#500-95-0059), on confirming the appropriateness of administration of
intravenous immune globulin in the home setting, and (as appropriate)
calculate the amount, in addition to that made under section
1842(o)(1)(E)(ii) for immune globulins, that should be paid to
providers for clinical, compliance, and complication management
services for ensuring safe and efficacious delivery of immune globulins
in the home setting under 1861(s)(2)(Z). The Secretary shall pay such
amounts no later than January 1, 2008.''.
(c) Application of Criminal Record Request Provisions to IVIG In-
Home Providers.--Section 124(i)(1) of the Departments of Commerce,
Justice, State, the Judiciary, and Related Agencies Appropriations Act,
1999 (as contained in section 1(b) of Public Law 105-277; 112 Stat.
2681-74) is amended by adding at the end the following: ''Such term
includes an entity providing intravenous immune globulin under part B
of title XVIII of the Social Security Act in a home.''.
(d) Effective Date.--The amendments made by subsections (a) and (b)
shall apply to intravenous immune globulin administered on or after
January 1, 2008.

SEC. 5. PATIENT ACCESS SURVEYS AND REPORTS.

(a) Surveys.--The Secretary of Health and Human Services shall
conduct, not later than 3 years after the date of the enactment of this
Act, two surveys of Medicare and non-Medicare patients who need immune
globulins for the purpose of measuring changes in patient access to
those products (and providers furnishing those products), as well as
changes in the health care status of those patients. The Secretary may
enter into contracts with organizations or entities qualified to
conduct such surveys.
(b) Survey Reports.--Each of the surveys shall include a report to
the Secretary and the Committees on Energy and Commerce and Ways and
Means of the House of Representatives and the Committee on Finance of
the Senate on findings from the survey, as well as a discussion of
reasons for observed changes, if any.
(c) Congressional Reports.--On the basis of findings from such
surveys, the Secretary shall submit to Congress reports that include
recommendations on necessary adjustments in payments for immune
globulins under the Medicare program in order to assure beneficiary
access to those products and providers that furnish those products. The
first such report shall be submitted no later than 2 years after the
date of the enactment of this Act and the second report no later than
four years after such date.
A:
Medicare IVIG Access Act of 2007 - Amends title XVIII (Medicare) of the Social Security Act to direct the Secretary of Health and Human Services to collect and review data on the differences, if any, between: (1) payments to physicians for immune globulins using average sales price payment methodology; and (2) costs incurred by physicians for furnishing these products.

Requires the Secretary, after completion of the review, to provide, if appropriate, an additional payment to such physicians for all items related to the furnishing of immune globulins as part of hospital outpatient services.

Provides for Medicare coverage of and payment for intravenous immune globulin (IVIG) administered in the home.

Directs the Secretary to conduct two surveys, for reports to Congress, of Medicare and non-Medicare patients who need immune globulins in order to measure changes in patient access to those products (and providers furnishing them), as well as changes in the health care status of those patients.