TASK DEFINITION: In this task, you are given text for US Congressional and California state bills, your task is to generate a summary for this bill.
PROBLEM: SECTION 1. SHORT TITLE.

This Act may be cited as the ''Medicare Spending Transparency Act
of 2011''.

SEC. 2. PUBLIC AVAILABILITY OF AGGREGATE DATA ON MEDICARE PROVIDERS OF
SERVICES AND SUPPLIERS.

(a) Purpose.--The purpose of this section is to make aggregate
information about providers of services and suppliers under the
Medicare program under title XVIII of the Social Security Act (42
U.S.C. 1395 et seq.) publicly available and to provide a new level of
transparency in such program.
(b) Public Availability.--Section 1128J of the Social Security Act
(42 U.S.C. 1320a-7k) is amended by adding at the end the following new
subsection:
''(f) Public Availability of Certain Medicare Data.--
''(1) In general.--The Secretary shall, to the extent
consistent with applicable information, privacy, security, and
disclosure laws, including the regulations promulgated under
the Health Insurance Portability and Accountability Act of 1996
and section 552a of title 5, United States Code, make available
to the public on the Internet website of the Centers for
Medicare & Medicaid Services the following data with respect to
title XVIII:
''(A) A complete list of the providers of services
and suppliers participating in the program under such
title, including the business address of such providers
of services and suppliers.
''(B) Aggregate information about each such
provider of services and supplier, including--
''(i) the total number of individuals
furnished items or services by the provider of
services or supplier for which payment was made
under such title during the preceding year;
''(ii) the number of unique patient
encounters conducted by the provider of
services or supplier for which payment was made
under such title during the preceding year;
''(iii) the average number of codes billed
under such title by the provider of services of
supplier per patient encounter during the
preceding year;
''(iv) the total amount paid to such
provider of services or supplier under such
title during the preceding year;
''(v) the top 50 billing codes on claims
paid under such title to the provider of
services or supplier during the preceding year,
as determined by volume, including a
description of such codes;
''(vi) the top 50 billing codes on such
claims paid during such year, as determined by
dollar amount, including a description of such
codes; and
''(vii) the top 50 diagnosis and procedure
code pairs on such claims paid during such
year, as determined by volume, including a
description of such codes.
''(2) Implementation.--Not later than 1 year after the date
of enactment of the Medicare Spending Transparency Act of 2011,
the Secretary shall promulgate regulations to carry out this
subsection.''.

SEC. 3. ACCESS TO MEDICARE CLAIMS AND PAYMENT DATA BY QUALIFIED
INDIVIDUALS AND GROUPS.

(a) Purpose.--The purpose of this section is to allow qualified
individuals and groups access to information on claims and payment data
under the Medicare program for purposes of conducting health research
and detecting fraud under such program.
(b) Access to Medicare Claims and Payment Data by Qualified
Individuals and Groups.--Section 1128J of the Social Security Act (42
U.S.C. 1320a-7k), as amended by section 2, is amended by adding at the
end the following new subsection:
''(g) Access to Medicare Claims and Payment Data by Qualified
Individuals and Groups.--
''(1) In general.--For purposes of conducting health
research and detecting fraud under title XVIII, and to the
extent consistent with applicable information, privacy,
security, and disclosure laws, including the regulations
promulgated under the Health Insurance Portability and
Accountability Act of 1996 and section 552a of title 5, United
States Code, and subject to any information systems security
requirements under such laws or otherwise required by the
Secretary, a qualified individual or group shall have access to
claims and payment data of the Department of Health and Human
Services and its contractors related to title XVIII.
Notwithstanding any other provision of law, such data shall
include the identity of individual providers of services and
suppliers under such title.
''(2) Definition of qualified individual or group.--
''(A) In general.--In this subsection, the term
'qualified individual or group' means an individual or
entity that the Secretary has determined, in accordance
with subparagraph (B), has relevant experience,
knowledge, and technical expertise in medicine,
statistics, health care billing, practice patterns,
health care fraud detection, and analysis to use data
provided to the individual or the entity under this
subsection in an appropriate, responsible, and ethical
manner and for the purposes described in paragraph (1).
''(B) Procedures.--The Secretary shall establish
procedures for determining, in a timely manner, whether
an individual or entity is a qualified individual or
group.
''(3) Procedures.--The Secretary shall establish procedures
for the storage and use of data provided to a qualified
individual or group under this subsection. Such procedures
shall ensure that, in the case where the qualified individual
or group publishes an analysis of such data (or any analysis
using such data), the qualified individual or group discloses
the following information (in a form and manner, and at a time,
specified by the Secretary):
''(A) The name of the qualified individual or
group.
''(B) The sources of any funding for the qualified
individual or group.
''(C) Any employer or other relevant affiliations
of the qualified individual or group.
''(D) The data analysis methods used by the
qualified individual or group in the analysis
involved.''.

SOLUTION: Medicare Spending Transparency Act of 2011 - Amends title XI of the Social Security Act (SSA) to direct the Secretary of Health and Human Services (HHS), consistent with applicable information, privacy, security, and disclosure laws, to make public on the Internet website of the Centers for Medicare and Medicaid Services the following data with respect to SSA title XVIII (Medicare): (1) a complete list of service providers and suppliers participating in the Medicare program, including their business addresses; and (2) certain aggregate information about each provider and supplier.

Entitles a qualified individual or group, for health research and fraud detection purposes, to access to Medicare claims and payment data of both HHS and its contractors. Directs the Secretary to establish procedures for the storage and use of data provided to such an individual or group.

PROBLEM: SECTION 1. SHORT TITLE.

This Act may be cited as the ''Medical Devices Technical
Corrections Act''.

SEC. 2. TECHNICAL CORRECTIONS REGARDING PUBLIC LAW 107-250.

(a) Title I; Fees Relating to Medical Devices.--Part 3 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379i et seq.), as added by section 102 of Public Law 107-250
(116 Stat. 1589), is amended--
(1) in section 737--
(A) in paragraph (4)(B), by striking ''and for which
clinical data are generally necessary to provide a reasonable
assurance of safety and effectiveness'' and inserting ''and for
which substantial clinical data are necessary to provide a
reasonable assurance of safety and effectiveness'';
(B) in paragraph (4)(D), by striking ''manufacturing,'';
(C) in paragraph (5)(J), by striking ''a premarket
application'' and all that follows and inserting ''a premarket
application or premarket report under section 515 or a
premarket application under section 351 of the Public Health
Service Act.''; and
(D) in paragraph (8), by striking ''The term 'affiliate'
means a business entity that has a relationship with a second
business entity'' and inserting ''The term 'affiliate' means a
business entity that has a relationship with a second business
entity (whether domestic or international)''; and
(2) in section 738--
(A) in subsection (a)(1)--
(i) in subparagraph (A)--

(I) in the matter preceding clause (i) by striking
''subsection (d),'' and inserting ''subsections (d) and
(e),'';
(II) in clause (iv), by striking ''clause (i),''
and all that follows and inserting ''clause (i).''; and
(III) in clause (vii), by striking ''clause (i),''
and all that follows and inserting ''clause (i),
subject to any adjustment under subsection
(e)(2)(C)(ii).''; and

(ii) in subparagraph (D), in each of clauses (i) and
(ii), by striking ''application'' and inserting
''application, report,'';
(B) in subsection (d)(2)(B), beginning in the second
sentence, by striking ''firms. which show'' and inserting
''firms, which show'';
(C) in subsection (e)--
(i) in paragraph (1), by striking ''Where'' and
inserting ''For fiscal year 2004 and each subsequent fiscal
year, where''; and
(ii) in paragraph (2)--

(I) in subparagraph (B), beginning in the second
sentence, by striking ''firms. which show'' and
inserting ''firms, which show''; and
(II) in subparagraph (C)(i), by striking ''Where''
and inserting ''For fiscal year 2004 and each
subsequent fiscal year, where'';

(D) in subsection (f), by striking ''for filing''; and
(E) in subsection (h)(2)(B)--
(i) in clause (ii), by redesignating subclauses (I) and
(II) as items (aa) and (bb), respectively;
(ii) by redesignating clauses (i) and (ii) as
subclauses (I) and (II), respectively;
(iii) by striking ''The Secretary'' and inserting the
following:
''(i) In general.--The Secretary''; and
(iv) by adding at the end the following:
''(ii) More than 5 percent.--To the extent such costs
are more than 5 percent below the specified level in
subparagraph (A)(ii), fees may not be collected under this
section for that fiscal year.''.
(b) Title II; Amendments Regarding Regulation of Medical Devices.--
(1) Inspections by accredited persons.--Section 704(g) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(g)), as added
by section 201 of Public Law 107-250 (116 Stat. 1602), is amended--
(A) in paragraph (1), in the first sentence, by striking
''conducting inspections'' and all that follows and inserting
''conducting inspections of establishments that manufacture,
prepare, propagate, compound, or process class II or class III
devices, which inspections are required under section 510(h) or
are inspections of such establishments required to register
under section 510(i).'';
(B) in paragraph (5)(B), in the first sentence, by striking
''or poses'' and all that follows through the period and
inserting ''poses a threat to public health, fails to act in a
manner that is consistent with the purposes of this subsection,
or where the Secretary determines that there is a financial
conflict of interest in the relationship between the accredited
person and the owner or operator of a device establishment that
the accredited person has inspected under this subsection.'';
(C) in paragraph (6)(A)--
(i) in clause (i), by striking ''of the establishment
pursuant to subsection (h) or (i) of section 510'' and
inserting ''described in paragraph (1)'';
(ii) in clause (ii)--

(I) in the matter preceding subclause (I)--

(aa) by striking ''each inspection'' and
inserting ''inspections''; and
(bb) by inserting ''during a 2-year period''
after ''person''; and

(II) in subclause (I), by striking ''such a
person'' and inserting ''an accredited person'';

(iii) in clause (iii)--

(I) in the matter preceding subclause (I), by
striking ''and the following additional conditions are
met:'' and inserting ''and 1 or both of the following
additional conditions are met:'';
(II) in subclause (I), by striking ''accredited''
and all that follows through the period and inserting
''(accredited under paragraph (2) and identified under
clause (ii)(II)) as a person authorized to conduct such
inspections of device establishments.''; and
(III) in subclause (II), by inserting ''or by a
person accredited under paragraph (2)'' after ''by the
Secretary'';

(iv) in clause (iv)(I)--

(I) in the first sentence--

(aa) by striking ''the two immediately
preceding inspections of the establishment'' and
inserting ''inspections of the establishment during
the previous 4 years''; and
(bb) by inserting ''section'' after ''pursuant
to'';

(II) in the third sentence--

(aa) by striking ''the petition states a
commercial reason for the waiver;''; and
(bb) by inserting ''not'' after ''the Secretary
has not determined that the public health would'';
and

(III) in the fourth sentence, by striking ''granted
until'' and inserting ''granted or deemed to be granted
until''; and

(v) in clause (iv)(II)--

(I) by inserting ''of a device establishment
required to register'' after ''to be conducted''; and
(II) by inserting ''section'' after ''pursuant
to'';

(D) in paragraph (6)(B)(iii)--
(i) in the first sentence, by striking '', and data
otherwise describing whether the establishment has
consistently been in compliance with sections 501 and 502
and other'' and inserting ''and with other''; and
(ii) in the second sentence--

(I) by striking ''inspections'' and inserting
''inspectional findings''; and
(II) by inserting ''relevant'' after ''together
with all other'';

(E) in paragraph (6)(B)(iv)--
(i) by inserting ''(I)'' after ''(iv)''; and
(ii) by adding at the end the following:
''(II) If, during the two-year period following clearance under
subparagraph (A), the Secretary determines that the device
establishment is substantially not in compliance with this Act, the
Secretary may, after notice and a written response, notify the
establishment that the eligibility of the establishment for the
inspections by accredited persons has been suspended.'';
(F) in paragraph (6)(C)(ii), by striking ''in accordance
with section 510(h), or has not during such period been
inspected pursuant to section 510(i), as applicable'';
(G) in paragraph (10)(B)(iii), by striking ''a reporting''
and inserting ''a report''; and
(H) in paragraph (12)--
(i) by striking subparagraph (A) and inserting the
following:
''(A) the number of inspections conducted by accredited persons
pursuant to this subsection and the number of inspections conducted
by Federal employees pursuant to section 510(h) and of device
establishments required to register under section 510(i);''; and
(ii) in subparagraph (E), by striking ''obtained by the
Secretary'' and all that follows and inserting ''obtained
by the Secretary pursuant to inspections conducted by
Federal employees;''.
(2) Other corrections.--
(A) Prohibited acts.--Section 301(gg) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331(gg)), as amended by
section 201(d) of Public Law 107-250 (116 Stat. 1609), is
amended to read as follows:
''(gg) The knowing failure to comply with paragraph (7)(E) of
section 704(g); the knowing inclusion by a person accredited under
paragraph (2) of such section of false information in an inspection
report under paragraph (7)(A) of such section; or the knowing failure
of such a person to include material facts in such a report.''.
(B) Electronic labeling.--Section 502(f) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 352(f)), as amended by
section 206 of Public Law 107-250 (116 Stat. 1613), is amended,
in the last sentence--
(i) by inserting ''or by a health care professional and
required labeling for in vitro diagnostic devices intended
for use by health care professionals or in blood
establishments'' after ''in health care facilities'';
(ii) by inserting a comma after ''means'';
(iii) by striking ''requirements of law and, that'' and
inserting ''requirements of law, and that'';
(iv) by striking ''the manufacturer affords health care
facilities the opportunity'' and inserting ''the
manufacturer affords such users the opportunity''; and
(v) by striking ''the health care facility''.
(c) Title III; Additional Amendments.--
(1) Effective date.--Section 301(b) of Public Law 107-250 (116
Stat. 1616), is amended by striking ''18 months'' and inserting
''36 months''.
(2) Premarket notification.--Section 510(o) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360(o)), as added by
section 302(b) of Public Law 107-250 (116 Stat. 1616), is amended--
(A) in paragraph (1)(B), by striking '', adulterated'' and
inserting ''or adulterated''; and
(B) in paragraph (2)--
(i) in subparagraph (B), by striking '', adulterated''
and inserting ''or adulterated''; and
(ii) in subparagraph (E), by striking ''semicritical''
and inserting ''semi-critical''.
(d) Miscellaneous Corrections.--
(1) Certain amendments to section 515.--
(A) In general.--
(i) Technical correction.--Section 515(c) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(c)),
as amended by sections 209 and 302(c)(2)(A) of Public Law
107-250 (116 Stat. 1613, 1618), is amended by redesignating
paragraph (3) (as added by section 209 of such Public Law)
as paragraph (4).
(ii) Modular review.--Section 515(c)(4)(B) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360e(c)(4)(B)) is amended by striking ''unless an issue of
safety'' and inserting ''unless a significant issue of
safety''.
(B) Conforming amendment.--Section 210 of Public Law 107-
250 (116 Stat. 1614) is amended by striking
'', as amended'' and all that follows through ''by adding'' and
inserting ''is amended in paragraph (3), as redesignated by
section 302(c)(2)(A) of this Act, by adding''.
(2) Certain amendments to section 738.--
(A) In general.--Section 738(a) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j(a)), as amended by subsection
(a), is amended--
(i) in the matter preceding paragraph (1)--

(I) by striking ''(a) Types of Fees.--Beginning
on'' and inserting the following:

''(a) Types of Fees.--
''(1) In general.--Beginning on''; and

(II) by striking ''this section as follows:'' and
inserting ''this section.''; and

(ii) by striking ''(1) Premarket application,'' and
inserting the following: ''(2) Premarket application,''.
(B) Conforming amendments.--Section 738 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j), as amended by
subparagraph (A), is amended--
(i) in subsection (d)(1), in the last sentence, by
striking ''subsection (a)(1)(A)'' and inserting
''subsection (a)(2)(A)'';
(ii) in subsection (e)(1), by striking ''subsection
(a)(1)(A)(vii)'' and inserting ''subsection
(a)(2)(A)(vii)'';
(iii) in subsection (e)(2)(C)--

(I) in each of clauses (i) and (ii), by striking
''subsection (a)(1)(A)(vii)'' and inserting
''subsection (a)(2)(A)(vii)''; and
(II) in clause (ii), by striking ''subsection
(a)(1)(A)(i)'' and inserting ''subsection
(a)(2)(A)(i)''; and

(iv) in subsection (j), by striking ''subsection
(a)(1)(D),'' and inserting ''subsection (a)(2)(D),''.
(C) Additional conforming amendment.--Section 102(b)(1) of
Public Law 107-250 (116 Stat. 1600) is amended, in the matter
preceding subparagraph (A), by striking ''section
738(a)(1)(A)(ii)'' and inserting ''section 738(a)(2)(A)(ii)''.
(3) Public law 107-250.--Public Law 107-250 is amended--
(A) in section 102(a) (116 Stat. 1589), by striking ''(21
U.S.C. 379F et seq.)'' and inserting ''(21 U.S.C. 379f et
seq.)'';
(B) in section 102(b) (116 Stat. 1600)--
(i) by striking paragraph (2);
(ii) in paragraph (1), by redesignating subparagraphs
(A) and (B) as paragraphs (1) and (2), respectively; and
(iii) by striking:
''(b) Fee Exemption for Certain Entities Submitting Premarket
Reports.--
''(1) In general.--A person submitting a premarket report'' and
inserting:
''(b) Fee Exemption for Certain Entities Submitting Premarket
Reports.--A person submitting a premarket report''; and
(C) in section 212(b)(2) (116 Stat. 1614), by striking '',
such as phase IV trials,''.
SEC. 3. REPORT ON BARRIERS TO AVAILABILITY OF DEVICES INTENDED FOR
CHILDREN.
Not later than 180 days after the date of enactment of this Act,
the Secretary of Health and Human Services shall submit to the
Committee on Health, Education, Labor, and Pensions of the Senate and
the Committee on Energy and Commerce of the House of Representatives a
report on the barriers to the availability of devices intended for the
treatment or diagnosis of diseases and conditions that affect children.
The report shall include any recommendations of the Secretary of Health
and Human Services for changes to existing statutory authority,
regulations, or agency policy or practice to encourage the invention
and development of such devices.

Speaker of the House of Representatives.

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

SOLUTION: Medical Devices Technical Corrections Act - Amends the Federal Food, Drug, and Cosmetic Act (as amended by the Medical Device User Fee and Modernization Act of 2002) to revise provisions concerning medical devices user fees.

Prohibits the Secretary of Health and Human Services from collecting fees to defray costs in any fiscal year where the amount appropriated is more than five percent below the costs of the resources allocated for the review of device applications.

Allows the Secretary to withdraw accreditation to inspect from any person where the Secretary determines that there is a conflict of interest between the company and the accredited inspector.

Permits a company that markets at least one medical device in the United States and one medical device in another country to use an accredited third party inspector if the company certifies that the foreign country recognizes inspections by: (1) the Food and Drug Administration (FDA); and/or (2) the third party inspector. (Current law requires a country to recognize both types of inspections.)

Allows the Secretary to withdraw eligibility for third party inspections from a company if the Secretary determines that the company is substantially not in compliance with the Act.

Allows electronic labeling for prescription devices intended for use by health care professionals and for in vitro diagnostic devices intended for use by health care professionals or in blood establishments.

Delays by 18 additional months the effective date of the provision deeming a device misbranded if the identification of the manufacturer is not conspicuously displayed.

Directs the Secretary to submit a report to the relevant committees on the barriers to the availability of devices intended for treatment or diagnosis of diseases or conditions that affect children.

PROBLEM: SECTION 1. SHORT TITLE.

This Act may be cited as the ''HHS Women Scientist Employment
Opportunity Act''.

SEC. 2. WOMEN'S SCIENTIFIC EMPLOYMENT.

The Public Health Service Act (42 U.S.C. 201 et seq.) is amended by
adding at the end the following title:

''TITLE XXVIII--WOMEN'S SCIENTIFIC EMPLOYMENT WITH DEPARTMENT OF HEALTH
AND HUMAN SERVICES

''SEC. 2801. WOMEN'S SCIENTIFIC EMPLOYMENT.

''(a) In General.--
''(1) In general.--For each agency specified in paragraph
(2), the Secretary, in collaboration with the head of the
agency, shall--
''(A) establish policies for the agency on matters
relating to the employment by the agency of women as
scientists, and periodically review and as appropriate
revise such policies; and
''(B) monitor the extent of compliance with such
policies and take appropriate action in cases in which
the Secretary determines that the policies have been
violated.
''(2) Specified agencies.--The agencies referred to in
paragraph (1) are the National Institutes of Health, the
Centers for Disease Control and Prevention, the Food and Drug
Administration, and such other agencies or offices of the
Department of Health and Human Services as the Secretary
determines to be appropriate.
''(b) Certain Functions.--
''(1) In general.--In carrying out subsection (a) with
respect to a specified agency, the Secretary shall provide for
the following:
''(A) Determining the concerns of women scientists
employed at the agency.
''(B) Developing a policy defining the standard
tenure process for employment at the agency.
''(C) Determining the reason for departure from the
agency by interviewing women and men scientists as they
leave.
''(D) Distributing yearly to all employees of the
agency copies of the policy of the agency on flexible
family leave.
''(E) Monitoring the number of women, including
minority women, included on the committees, panels, and
other working groups (and in meetings) of the agency.
''(F) Making efforts to recruit minority women,
based on the small numbers of tenured minority women
scientists.
''(G) Developing additional goals related to women
and minority women scientists at the agency.
''(2) Agency-specific provisions.--With respect to the
National Institutes of Health, in carrying out subsection (a),
the Secretary shall (in addition to activities under paragraph
(1)) provide for the implementation of the recommendations of
the group known as the Task Force on the Status of NIH
Intramural Women Scientists.
''(c) Inclusion of Women on Intramural and Extramural Conferences
and Other Groups.--
''(1) In general.--The Secretary shall establish a policy
at each specified agency of requiring inclusion of women
scientists in greater numbers on or in conferences, workshops,
meetings, international congresses, and other groups funded or
sponsored by the agency. Such policy shall provide for the
inclusion of not less than one woman scientist in each such
group, except as provided in paragraph (2). This paragraph
applies whether such groups are held for employees of the
agency headquarters, for employees of field offices, or both.
''(2) Exclusion; written explanation.--The policy
established in paragraph (1) may provide that no woman
scientist will be included in a group for purposes of such
paragraph if the Secretary provides a waiver of the
requirement. The Secretary may grant such a waiver only if--
''(A) the individual with the chief responsibility
for the group involved submits to the Secretary a
written request for the waiver and the request provides
an explanation of the reasons underlying the need for
the waiver; and
''(B) the Secretary makes a determination that
extraordinary circumstances justify providing the
waiver.
''(d) Study on Pay Equity.--
''(1) In general.--For each specified agency, the Secretary
shall provide for a study to identify any pay differences among
men and women scientists employed by the agency, both tenured
and untenured. The study shall include recommendations on
measures to adjust any disparities or inequities, and shall
identify a program to communicate information on salary ranges
to all employees.
''(2) Report.--Not later than 240 days after the date of
the enactment of the HHS Women Scientist Employment Opportunity
Act, the Secretary shall complete the study required in
paragraph (1) and submit to the Committee on Commerce of the
House of Representatives, and to the Committee on Labor and
Human Resources of the Senate, a report describing the findings
made as a result of the study.
''(e) Definitions.--For purposes of this section, the term
'specified agency' means an agency specified in subsection (a)(2).
''(f) Authorization of Appropriations.--For the purpose of carrying
out this section, there are authorized to be appropriated such sums as
may be necessary for each of the fiscal years 2000 through 2002.''.

SOLUTION:
HHS Women Scientist Employment Opportunity Act - Directs the Secretary of Health and Human Services to: (1) establish policies for the Department of Health and Human Services on matters relating to the employment of women scientists; and (2) monitor compliance and take appropriate action if policies have been violated. Mandates implementation of the recommendations of the Task Force on the Status of NIH (National Institutes of Health) Intramural Women Scientists. Provides for a study and report on pay equity. Authorizes appropriations.