SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Separation of Powers Restoration
Act''.

SEC. 2. FINDINGS.

    The Congress finds the following:
            (1) As a limit on governmental power, Constitutional
        framers vested Federal powers in three coequal branches of
        government, each with unique and limited powers and each with a
        coequal duty to uphold and sustain the Constitution of the
        United States.
            (2) A Supreme Court justice stated, ``The doctrine of the
        separation of powers was adopted by the convention of 1787 not
        to promote efficiency but to preclude the exercise of arbitrary
        power. The purpose was not to avoid friction, but, by means of
        the inevitable friction incident to the distribution of the
        governmental powers among three departments, to save the people
        from autocracy.'' Myers v. United States, 272 U.S. 52, 293
        (1926) (Brandeis, J., dissenting).
            (3) James Madison, quoting Montesquieu, stated in
        Federalist 47, ```There can be no liberty where the legislative
        and executive powers are united in the same person, or body of
        magistrates.'''
            (4) Article I of the Constitution provides, ``All
        legislative powers herein granted shall be vested in a Congress
        of the United States.''
            (5) A congressional committee print has noted that,
        ``[b]ecause the President has no power or authority over
        individual citizens and their rights except where he is granted
        such power and authority by a provision in the Constitution or
        by statute, the President's proclamations are not legally
        binding and are at best hortatory unless based on such grants
        of authority.'' 85th Cong., 1st Sess., Executive Orders and
        Proclamations: A Study of a Use of Presidential Powers (Comm.
        Print 1957).
            (6) The Supreme Court has stated that, even if Presidents
        have, without congressional authority, taken actions only the
        Congress may take, ``Congress has not thereby lost its
        exclusive constitutional authority to make laws necessary and
        proper to carry out the powers vested by the Constitution `in
        the Government of the United States, or any Department of
        Officer thereof.''' (Youngstown Sheet and Tube Co. v. Sawyer,
        343 U.S. 579 (1952)).
            (7) Treaties or Executive Agreements which purport to
        assign powers not amongst those specifically granted to the
        Federal Government by the Constitution are non-binding and
        cannot constitute law.

SEC. 3. EFFECT OF PRESIDENTIAL ORDERS.

    (a) Limited Effect of Presidential Orders.--A Presidential order
neither constitutes nor has the force of law and is limited in its
application and effect to the executive branch.
    (b) Exceptions.--Subsection (a) does not apply to--
            (1) a reprieve or pardon for an offense against the United
        States, except in cases of impeachment;
            (2) an order given to military personnel pursuant to duties
        specifically related to actions taken as Commander in Chief of
        the Armed Forces; or
            (3) a Presidential order citing the specific congressional
        enactment relied upon for the authority exercised in such order
        and--
                    (A) issued pursuant to such authority;
                    (B) commensurate with the limit imposed by the
                plain language of such authority; and
                    (C) not issued pursuant to a ratified or unratified
                treaty or bilateral or multilateral agreement which--
                            (i) violates the ninth or tenth amendments
                        to the Constitution; or
                            (ii) makes a delegation of power to a
                        foreign government or international body when
                        no such delegating authority exists under the
                        Constitution.

SEC. 4. REQUIREMENT OF STATEMENT OF AUTHORITY FOR PRESIDENTIAL ORDERS.

    (a) Statement of Authority.--The President shall provide for each
Presidential order a statement of the specific statutory or
constitutional provision which in fact grants the President the
authority claimed for such action.
    (b) Invalidity of Nonconforming Orders.--A Presidential order which
does not include the statement required by subsection (a) is invalid,
to the extent such Presidential order is issued under authority granted
by a congressional enactment. This subsection applies to Presidential
orders in effect on or after the date that is 180 days after the date
of enactment of this Act.

SEC. 5. STANDING TO CHALLENGE PRESIDENTIAL ORDERS WHICH IMPACT
              SEPARATION OF POWERS INTEGRITY.

    The following persons may bring an action in an appropriate United
States court to challenge the validity of any Presidential order which
exceeds the power granted to the President by the relevant authorizing
statute or the Constitution:
            (1) Congress and its members.--The Congress, the House of
        Representatives, the Senate, any Senator, and any
        Representative to the House of Representatives, if the
        challenged Presidential order--
                    (A) infringes on any power of Congress;
                    (B) exceeds any power granted by a congressional
                enactment; or
                    (C) violates section 4 because it does not state
                the statutory authority which in fact grants the
                President the power claimed for the action taken in
                such Presidential order.
            (2) State and local governments.--The highest governmental
        official of any State, commonwealth, district, territory, or
        possession of the United States, or any political subdivision
        thereof, or the designee of such person, if the challenged
        Presidential order infringes on a power of such State or on a
        power afforded to such commonwealth, district, territory, or
        possession under any congressional enactment or relevant treaty
        of the United States.
            (3) Aggrieved persons.--Any person aggrieved in a liberty
        or property interest adversely affected directly by the
        challenged Presidential order.

SEC. 6. NATIONAL EMERGENCY POWER DIVESTED TO CONGRESS.

    (a) Divestiture of Authority To Declare Emergency.--To the extent
that any Act of Congress in effect on the date of enactment of this Act
grants to the President or any other officer or employee of the
executive branch the power to declare a national emergency, such power
is hereby divested to the Congress alone.
    (b) Termination of Powers Under Existing States of Emergency.--
            (1) In general.--All powers and authorities possessed by
        the President, any other officer or employee of the Federal
        Government, or any executive agency (as defined in section 105
        of title 5, United States Code) as a result of the existence of
        any declaration of national emergency in effect on the date of
        enactment of this Act are terminated 90 days after the date of
        enactment of this Act. Such termination shall not affect--
                    (A) any action taken or proceeding pending that is
                not finally concluded or determined before such date of
                termination;
                    (B) any action or proceeding based on any act
                committed before such date termination; or
                    (C) any rights or duties that matured or penalties
                that were incurred prior to such date of termination.
            (2) National emergency defined.--For the purpose of this
        subsection, the term ``national emergency'' means a general
        declaration of emergency made by the President or any other
        officer or employee of the executive branch.

SEC. 7. PRESIDENTIAL ORDER DEFINED.

    In this Act, the term ``Presidential order'' means--
            (1) any Executive order, Presidential proclamation, or
        Presidential directive; and
            (2) any other Presidential or Executive action by whatever
        name described purporting to have normative effect outside the
        executive branch which is issued under the authority of the
        President or any other officer or employee of the executive
        branch.

Summary: Separation of Powers Restoration Act - States that a presidential order, with specific exceptions, neither constitutes nor has the force of law and is limited in application and effect to the executive branch. Directs the President to provide with each presidential order a statement of the specific statutory or constitutional authority for such action. Authorizes both Houses of Congress, a Senator or Representative, certain State and local officials, and certain aggrieved persons to bring an action to challenge the validity of any presidential order which exceeds the power granted to the President by the relevant authorizing statute or the Constitution. States that, to the extent that any Act of Congress grants to the President or any other executive officer or employee the power to declare a national emergency, such power is divested to Congress alone. Terminates after 90 days all powers and authorities possessed by the President or any other Federal officer or employee or executive agency as a result of the existence of a declaration of national emergency in effect on the date of enactment of this Act.

To restore the separation of powers between the Congress and the President.


SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Health Care Consumer Protection Act
of 1995''.

SEC. 2. NOTIFICATION OF COVERAGE PROVIDED BY THE INSURER.

    (a) Notification to Current Enrollees.--An insurer providing health
insurance coverage under a health plan shall provide annual notice to
each current enrollee under such plan regarding the extent of the
coverage of the plan. Such notice shall be in writing and shall include
a copy of the contract between the insurer and enrollee, in addition to
information regarding the terms and conditions of the policy and the
rights and obligations of the parties including--
            (1) covered and excluded services, equipment, and devices;
            (2) copayments, deductibles, and premiums;
            (3) enrollee satisfaction statistics;
            (4) financial responsibility of the enrollee;
            (5) utilization review requirements;
            (6) a list of the usual, customary, and reasonable costs
        for procedures, tests, and examinations;
            (7) physician credentialing standards; and
            (8) the percentage of total annual premiums used to
        reimburse practitioners for health care provided to enrollees
        and the percentage used for administration and other costs
        incurred in administering the plan.
    (b) Notification to Potential Enrollees.--An insurer providing
health insurance coverage under a health plan shall, upon request,
provide notice to each potential enrollee under such plan regarding the
extent of the coverage of the plan. Such notice shall be in writing and
shall include a copy of the potential contract between the insurer and
potential enrollee, in addition to information regarding the terms and
conditions of the policy and the rights and obligations of the parties
information including the items listed in paragraphs (1) through (8) of
subsection (a).
    (c) Regulations for Failure To Provide Notification.--The Secretary
of Health and Human Services shall promulgate regulations to ensure
that an insurer providing health insurance coverage under a health plan
provide notification to current and potential enrollees as described in
subsections (a) and (b).

SEC. 3. DETERMINATION OF MEDICALLY NECESSARY AND APPROPRIATE TREATMENT.

    (a) In General.--Under a health plan, the determination of what is
medically necessary and appropriate for the health of a patient may be
made only by a health care practitioner who is--
            (1) licensed and practicing within the scope of the State
        practice act of the State in which the practitioner practices;
        and
            (2) directly involved in the care of such patient.
    (b) Insurance Coverage.--An insurer must pay for a service
determined, as described in subsection (a), to be medically necessary
and appropriate if the service is covered by the health plan.
    (c) Regulations To Deter Rewards, Penalties or Inducements.--The
Secretary of Health and Human Services shall promulgate regulations to
ensure that an insurer not offer monetary rewards, penalties, or
inducements to a licensed health care practitioner, or condition the
continued participation of a licensed health care practitioner in a
plan on the basis of the health care practitioner's decisions to limit
the availability of appropriate medical tests, services, or treatments.

SEC. 4. ENFORCEMENT AND PENALTIES.

    (a) Penalties.-- Any entity that offers a health plan that violates
the provisions of this Act shall be subject to a civil money penalty in
an amount to be determined by the Secretary of Health and Human
Services.
    (b) Process.--The provisions of section 1128A of the Social
Security Act (42 U.S.C. 1320a-7a) (other than subsections (a) and (b))
shall apply to civil money penalties under this section in the same
manner as they apply to a penalty or proceeding under section 1128A(a)
of such Act.

SEC. 5. PROHIBITION OF HOLD HARMLESS PROVISIONS.

    An insurer may not include provisions in a health plan to hold
itself harmless for any liability.

SEC. 6. PREEMPTION.

    A State may not establish or enforce standards for insurers or
health insurance coverage with respect to the subject matter of this
Act that are weaker than the standards established under this Act.

SEC. 7. DEFINITIONS.--

    For purposes of this Act:
            (1) Insurer.--The term ``insurer'' means an insurance
        company, insurance service, or insurance organization licensed
        to engage in the business of insurance in a State, and a health
        maintenance organization.
            (2) Health care practitioner.--The term ``health care
        practitioner'' has the meaning provided by section 11151 of
        title 42, United States Code.
            (3) Health insurance coverage.--The term ``health insurance
        coverage'' means any hospital or medical service policy or
        certificate, hospital or medical service plan contract, or
        health maintenance organization contract offered by an insurer.
            (4) Health plan.--The term ``health plan'' means a plan
        that provides health insurance coverage.
            (5) State.--The term ``State'' means any State, the
        District of Columbia, Puerto Rico, the Northern Mariana
        Islands, the Virgin Islands, American Samoa, and Guam.

SEC. 8. EFFECTIVE DATE.

    The provisions of this Act shall apply to all health plans offered,
sold, issued, or renewed after the date of the enactment of this Act.

Summary: Health Care Consumer Protection Act of 1995 - Requires health insurers to provide notice regarding the extent of plan coverage to enrollees annually and to potential enrollees on request. Requires that, under a health plan, the determination of what is medically necessary and appropriate for a patient be made only by a health care practitioner directly involved in the patient's care. Requires an insurer to pay for a service that is so determined if the service is covered by the plan. Mandates regulations to ensure against insurers offering monetary rewards, penalties, or inducements to a practitioner, or conditioning continued practitioner participation in the plan, on the basis of the practitioner's decisions to limit the availability of appropriate tests, services, or treatments. Imposes a civil monetary penalty for violations of this Act. Prohibits insurers from including provisions in a plan to hold itself harmless for liability. Prohibits States from establishing or enforcing standards weaker than those of this Act.


SECTION 1. CONTINUATION OF SURVIVOR ANNUITIES FOR REMARRIED SPOUSES OF
              FEDERAL PUBLIC SAFETY OFFICERS KILLED IN THE LINE OF
              DUTY.

    (a) Short Title.--This Act may be cited as the ``Federal Public
Safety Officer Surviving Spouse Protection Act of 2005''.
    (b) Civil Service Retirement System.--Section 8341 of title 5,
United States Code, is amended--
            (1) in subsection (b)(3)(B) by striking ``subsection (k)''
        and inserting ``subsection (j)'';
            (2) in subsection (d) in clause (ii) of the last
        undesignated sentence by striking ``subsection (k)'' and
        inserting ``subsection (j)'';
            (3) in subsection (h)(3)(B)(i) by striking ``subsection
        (k)'' and inserting ``subsection (j)''; and
            (4) by striking subsection (k) and inserting the following:
    ``(j)(1) In this subsection, the term `Federal public safety
officer' means--
            ``(A) a law enforcement officer; or
            ``(B) an employee participating under this chapter who is--
                    ``(i) a public safety officer as defined under
                section 1204 of the Omnibus Crime Control and Safe
                Streets Act of 1968 (42 U.S.C. 3796b); or
                    ``(ii) an employee of the Department of the
                Treasury who is performing official duties of the
                Department in an area, if those official duties--
                            ``(I) are related to a major disaster or
                        emergency that has been, or is later, declared
                        to exist with respect to the area under the
                        Robert T. Stafford Disaster Relief and
                        Emergency Assistance Act (42 U.S.C. 5121 et
                        seq.); and
                            ``(II) are determined by the Secretary of
                        the Treasury to be hazardous duties.
    ``(2) Subsections (b)(3)(B), (d)(ii), and (h)(3)(B)(i) (to the
extent that they provide for termination of a survivor annuity because
of a remarriage before the age of 55 years) shall not apply if--
            ``(A) the widow, widower, or former spouse was married for
        at least 30 years to the individual on whose service the
        survivor annuity is based; or
            ``(B) in the case of a widow or widower the individual on
        whose service the survivor annuity is based was a Federal
        public safety officer who was killed in the line of duty.
    ``(3) A remarriage described under paragraph (2) shall not be taken
into account for purposes of section 8339(j)(5) (B) or (C) or any other
provision of this chapter which the Office may by regulation identify
in order to carry out the purposes of this subsection.''.
    (c) Federal Employees Retirement System.--Section 8442(d) of title
5, United States Code, is amended by striking paragraph (3) and
inserting the following:
            ``(3)(A) In this paragraph, the term `Federal public safety
        officer' means--
                    ``(i) a law enforcement officer; or
                    ``(ii) an employee participating under this chapter
                who is--
                            ``(I) a public safety officer as defined
                        under section 1204 of the Omnibus Crime Control
                        and Safe Streets Act of 1968 (42 U.S.C. 3796b);
                        or
                            ``(II) an employee of the Department of the
                        Treasury who is performing official duties of
                        the Department in an area, if those official
                        duties--
                                    ``(aa) are related to a major
                                disaster or emergency that has been, or
                                is later, declared to exist with
                                respect to the area under the Robert T.
                                Stafford Disaster Relief and Emergency
                                Assistance Act (42 U.S.C. 5121 et
                                seq.); and
                                    ``(bb) are determined by the
                                Secretary of the Treasury to be
                                hazardous duties.
            ``(B) Paragraph (1)(B) (relating to termination of a
        survivor annuity because of a remarriage before the age of 55
        years) shall not apply if--
                    ``(i) the widow or widower was married for at least
                30 years to the individual on whose service the
                survivor annuity is based; or
                    ``(ii) the individual on whose service the survivor
                annuity is based was a Federal public safety officer
                who was killed in the line of duty.''.
    (d) Effective Date.--The amendments made by this Act shall take
effect on January 1, 1988, and apply only to remarriages which occur on
or after that date.

Summary: Federal Public Safety Officer Surviving Spouse Protection Act of 2005 - Revises the Civil Service Retirement System (CSRS) and the Federal Employees' Retirement System (FERS) to permit, effective as of January 1, 1988, and only for remarriages occurring on or after that date, remarried widows and widowers of Federal public safety officers who are killed in the line of duty to continue to receive a survivor annuity.

A bill to amend chapters 83 and 84 of title 5, United States Code, to provide that spouses of Federal public safety officers who are killed in the line of duty, may remarry and continue to receive a survivor annuity, and for other purposes.


SECTION 1. LEGAL ASSISTANCE FOR FINANCIALLY NEEDY VETERANS IN
              CONNECTION WITH COURT OF VETERANS APPEALS PROCEEDINGS.

    (a) In General.--(1) Subchapter III of chapter 72 of title 38,
United States Code, is amended by adding at the end the following:
``Sec. 7287. Legal assistance for certain veterans in Court
              proceedings; use of funds for assistance
    ``(a)(1) The Court may, in accordance with this section, provide
funds (in advance or by way of reimbursement) to nonprofit
organizations, under such terms and conditions consistent with this
section as the Court considers appropriate, in order to permit such
organizations to provide financial assistance by grant or contract to
such legal assistance entities as the organizations consider
appropriate for purposes of permitting such entities to carry out
programs described in subsection (b).
    ``(2) Notwithstanding any other provision of law, if the Court
determines that there exists no nonprofit organization that would be an
appropriate recipient of funds under this section for the purposes
referred to in paragraph (1) and that it is consistent with the mission
of the Court, the Court may provide financial assistance, by grant or
contract, directly to such legal assistance entities as the Court
considers appropriate for purposes of permitting such entities to carry
out programs described in subsection (b).
    ``(b)(1) A program referred to in subsection (a) is any program
under which a legal assistance entity utilizes financial assistance
under this section to provide assistance or carry out activities
(including assistance, services, or activities referred to in paragraph
(3)) in order to ensure that individuals described in paragraph (2)
receive, without charge, legal assistance in connection with decisions
to which section 7252(a) of this title may apply or with other
proceedings before the Court.
    ``(2) An individual referred to in paragraph (1) is any veteran or
other person who--
            ``(A) is or seeks to be a party to an action before the
        Court; and
            ``(B) cannot, as determined by the Court or the entity
        concerned, afford the costs of legal advice and representation
        in connection with that action.
    ``(3) Assistance, services, and activities under a program
described in this subsection may include the following for individuals
described in paragraph (2) in connection with proceedings before the
Court:
            ``(A) Financial assistance to defray the expenses of legal
        advice or representation (other than payment of attorney fees)
        by attorneys, clinical law programs of law schools, and
        veterans service organizations.
            ``(B) Case screening and referral services for purposes of
        referring cases to pro bono attorneys and such programs and
        organizations.
            ``(C) Education and training of attorneys and other legal
        personnel who may appear before the Court by attorneys and such
        programs and organizations.
            ``(D) Encouragement and facilitation of the pro bono
        representation by attorneys and such programs and
        organizations.
    ``(4) A legal assistance entity that receives financial assistance
described in subsection (a) to carry out a program under this
subsection shall make such contributions (including in-kind
contributions) to the program as the nonprofit organization or the
Court, as the case may be, shall specify when providing the assistance.
    ``(5) A legal assistance entity that receives financial assistance
under subsection (a) to carry out a program described in this
subsection may not require or request the payment of a charge or fee in
connection with the program by or on behalf of any individual described
in paragraph (2).
    ``(c)(1) The Court may, out of the funds appropriated to the Court
for such purpose, provide funds to a nonprofit organization described
in subsection (a)(1), in advance or by way of reimbursement, to cover
some or all of the administrative costs of the organization in
providing financial assistance to legal assistance entities carrying
out programs described in subsection (b).
    ``(2) Funds shall be provided under this subsection pursuant to a
written agreement entered into by the Court and the nonprofit
organization receiving the funds.
    ``(d) Notwithstanding any other provision of law, a nonprofit
organization may--
            ``(1) accept funds, in advance or by way of reimbursement,
        from the Court under subsection (a)(1) in order to provide the
        financial assistance referred to in that subsection;
            ``(2) provide financial assistance by grant or contract to
        legal assistance entities under this section for purposes of
        permitting such entities to carry out programs described in
        subsection (b);
            ``(3) administer any such grant or contract; and
            ``(4) accept funds, in advance or by way of reimbursement,
        from the Court under subsection (c) in order to cover the
        administrative costs referred to in that subsection.
    ``(e)(1) Not later than February 1 each year, the Court shall
submit to Congress a report on the funds and financial assistance
provided under this section during the preceding fiscal year. Based on
the data provided the Court by entities receiving such funds and
assistance, each report shall--
            ``(A) set forth the amount, if any, of funds provided to
        nonprofit organizations under paragraph (1) of subsection (a)
        during the fiscal year covered by the report;
            ``(B) set forth the amount, if any, of financial assistance
        provided to legal assistance entities pursuant to paragraph (1)
        of subsection (a) or under paragraph (2) of that subsection
        during that fiscal year;
            ``(C) set forth the amount, if any, of funds provided to
        nonprofit organizations under subsection (c) during that fiscal
        year; and
            ``(D) describe the programs carried out under this section
        during that fiscal year.
    ``(2) The Court may require that the nonprofit organization and
legal assistance entities to which funds or financial assistance are
provided under this section provide the Court with such data on the
programs carried out under this section as the Court determines
necessary to prepare a report under this subsection.
    ``(g) For the purposes of this section:
            ``(1) The term `legal assistance entity' means a not-for-
        profit organization or veterans service organization capable of
        providing legal assistance to persons with respect to matters
        before the Court.
            ``(2) The term `Legal Services Corporation' means the
        corporation established under section 1003(a) of the Legal
        Services Corporation Act (42 U.S.C. 2996b(a)).
            ``(3) The term `nonprofit organization' means the Legal
        Services Corporation or any other similar not-for-profit
        organization that is involved with the provision of legal
        assistance to persons unable to afford such assistance.
            ``(4) The term `veterans service organization' means an
        organization referred to in section 5902(a)(1) of this title,
        including an organization approved by the Secretary under that
        section.''.
    (2) The table of sections at the beginning of such chapter is
amended by inserting after the item relating to section 7286 the
following new item:

``7287. Legal assistance for financially needy veterans in Court
                            proceedings; use of funds for
                            assistance.''.

Summary: Authorizes the United States Court of Veterans Appeals to provide funds to nonprofit organizations to permit such organizations to provide financial assistance to legal assistance entities, which will in turn provide legal advice or representation to veterans before the Court who cannot afford the costs of such advice and representation. Outlines the legal services to be included as part of such advice and representation. Prohibits the legal assistance entity from also charging the individual a fee for such advice or representation. Provides administrative authority for nonprofit organizations to accept funds for the purposes of this Act. Directs the Court to report annually to the Congress on the funds and financial assistance provided under this Act.

A bill to amend title 38, United States Code, to authorize the provision of financial assistance in order to ensure that financially needy veterans receive legal assistance in connection with proceedings before the United States Court of Veterans Appeals.


SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Janey Ensminger Act of 2016''.

SEC. 2. REVIEW OF ILLNESSES AND CONDITIONS RELATING TO VETERANS
              STATIONED AT CAMP LEJEUNE, NORTH CAROLINA, AND THEIR
              FAMILY MEMBERS.

    (a) Review and Publication of Illness or Condition.--Part P of
title III of the Public Health Service Act (42 U.S.C. 280g et seq.) is
amended by adding at the end the following:

``SEC. 399V-6. REVIEW AND PUBLICATION OF ILLNESSES AND CONDITIONS.

    ``(a) In General.--Consistent with section 104(i) of the
Comprehensive Environmental Response, Compensation, and Liability Act
of 1980, not later than 1 year after the date of enactment of this
section, and not less frequently than once every 3 years thereafter,
the Secretary, acting through the Administrator of the Agency for Toxic
Substances and Disease Registry, shall--
            ``(1)(A) review the scientific literature relevant to the
        relationship between the employment or residence of individuals
        at Camp Lejeune, North Carolina, for not fewer than 30 days
        during the period beginning on August 1, 1953, and ending on
        December 21, 1987, and specific illnesses or conditions
        incurred by those individuals;
            ``(B) determine each illness or condition for which there
        is evidence that exposure to a toxic substance at Camp Lejeune,
        North Carolina, during the period specified in subparagraph (A)
        may be a cause of the illness or condition; and
            ``(C) with respect to each illness or condition for which a
        determination has been made under subparagraph (B), categorize
        the evidence of the connection of the illness or condition to
        exposure described in that subparagraph as--
                    ``(i) sufficient to conclude with reasonable
                confidence that the exposure is a cause of the illness
                or condition;
                    ``(ii) modest supporting causation, but not
                sufficient to conclude with reasonable confidence that
                exposure is a cause of the illness or condition; or
                    ``(iii) no more than limited supporting causation;
            ``(2) publish in the Federal Register and on the Internet
        website of the Department of Health and Human Services--
                    ``(A) a list of each illness or condition for which
                a determination has been made under paragraph (1)(B),
                including the categorization of the evidence of causal
                connection relating to the illness or condition under
                paragraph (1)(C); and
                    ``(B) the bibliographic citations for all
                literature reviewed under paragraph (1) for each
                illness or condition listed under such paragraph; and
            ``(3) update the list under paragraph (2), as applicable,
        to add an illness or condition for which a determination has
        been made under paragraph (1)(B), including the categorization
        of the evidence of causal connection relating to the illness or
        condition under paragraph (1)(C), since such list was last
        updated consistent with the requirements of this subsection.''.
    (b) Eligibility for Health Care From Department of Veterans
Affairs.--
            (1) In general.--Section 1710(e)(1)(F) of title 38, United
        States Code, is amended--
                    (A) by redesignating clauses (i) through (xv) as
                subclauses (I) through (XV), respectively;
                    (B) by striking ``(F) Subject to'' and inserting
                ``(F)(i) Subject to'';
                    (C) by striking ``any of the following'' and
                inserting ``any of the illnesses or conditions for
                which the evidence of connection of the illness or
                condition to exposure to a toxic substance at Camp
                Lejeune, North Carolina, during such period is
                categorized as sufficient or modest in the most recent
                list published under section 399V-6(a)(2) of the Public
                Health Service Act, which may include any of the
                following''; and
                    (D) by adding at the end the following new clause:
    ``(ii) For the purposes of ensuring continuation of care, any
veteran who has been furnished hospital care or medical services under
this subparagraph for an illness or condition shall remain eligible for
hospital care or medical services for such illness or condition
notwithstanding that the evidence of connection of such illness or
condition to exposure to a toxic substance at Camp Lejeune, North
Carolina, during the period described in clause (i) is not categorized
as sufficient or modest in the most recent list published under section
399V-6(a)(2) of the Public Health Service Act.''.
            (2) Family members.--Section 1787 of such title is amended
        by adding at the end the following new subsection:
    ``(c) Continuation of Care.--For the purposes of ensuring
continuation of care, any individual who has been furnished hospital
care or medical services under this section for an illness or condition
shall remain eligible for hospital care or medical services for such
illness or condition notwithstanding that the illness or condition is
no longer described in section 1710(e)(1)(F) of this title.''.
            (3) Transfer of amounts for program.--Notwithstanding any
        other provision of law, for each of fiscal years 2017 and 2018,
        the Secretary of Veterans Affairs shall transfer $2,000,000
        from amounts made available to the Department of Veterans
        Affairs for medical support and compliance to the Chief
        Business Office and Financial Services Center of the Department
        to be used to continue building and enhancing the claims
        processing system, eligibility system, and web portal for the
        Camp Lejeune Family Member Program of the Department.

Summary: Janey Ensminger Act of 2016 This bill amends the Public Health Service Act to direct the Agency for Toxic Substances and Disease Registry, at least every three years, to: review the scientific literature relevant to the relationship between the employment or residence of individuals at Camp Lejeune, North Carolina, for at least 30 days during the period of August 1, 1953, to December 21, 1987, and specific illnesses or conditions incurred by those individuals and determine whether and to what extent the evidence shows that toxic substance exposure is a cause of an illness or condition. And publish and update a list of each illness and the categorization of evidence for which a determination of cause has been made. A veteran who served on active duty at Camp Lejeune for at least 30 days during such period is eligible for hospital care and medical services for any of the illnesses or conditions for which the evidentiary connection between toxic exposure and the illness or condition is categorized in such list as sufficient or modest. Such a veteran who has been furnished hospital care or medical services shall remain eligible for such care or services for such illness or condition even if the evidentiary connection is not categorized as sufficient or modest. A family member of such veteran who has been furnished hospital care or medical services shall remain eligible for hospital care or medical services for such illness or condition. The Department of Veterans Affairs shall transfer for each of FY2017 and FY2018 specified finds to enhance the claims processing system, eligibility system, and web portal for the Camp Lejeune Family Member Program.

Janey Ensminger Act of 2016


SECTION 1. SHORT TITLE AND PURPOSES.

    (a) Short Title.--This Act may be cited as the ``Character
Development Act''.
    (b) Purposes.--The purposes of this Act are--
            (1) to reduce the school dropout rate for at-risk youth;
            (2) to improve the academic performance of at-risk youth;
        and
            (3) to reduce juvenile delinquency and gang participation.

SEC. 2. DEFINITIONS.

    For the purposes of this Act--
            (1) the term ``at-risk youth'' means a youth at risk of--
                    (A) educational failure;
                    (B) dropping out of school; or
                    (C) involvement in delinquent activities;
            (2) the term ``eligible local educational agency'' means a
        local educational agency that has entered into a partnership,
        with a community-based organization that provides one-to-one
        mentoring services, to carry out the authorized activities
        described in section 5 in accordance with this Act;
            (3) the terms ``elementary school'', ``local educational
        agency'', and ``secondary school'', have the meanings given
        such terms in section 14101 of the Elementary and Secondary
        Education Act of 1965 (20 U.S.C. 8801);
            (4) the term ``mentor'' means a person who works with an
        at-risk youth on a one-to-one basis, to establish a supportive
        relationship with the youth and to provide the youth with
        academic assistance and exposure to new experiences that
        enhance the youth's ability to become a better student and a
        responsible citizen; and
            (5) the term ``Secretary'' means the Secretary of
        Education.

SEC. 3. MENTORING PROGRAMS.

    (a) Grant Authority.--The Secretary is authorized to award grants
to eligible local educational agencies to enable such agencies to
establish mentoring programs that--
            (1) are designed to link--
                    (A) individual at-risk youth; with
                    (B) responsible, individual adults who serve as
                mentors; and
            (2) are intended to--
                    (A) increase at-risk youth participation in, and
                enhance the ability of such youth to benefit from,
                elementary and secondary education;
                    (B) discourage at-risk youth from--
                            (i) using illegal drugs;
                            (ii) violence;
                            (iii) using dangerous weapons;
                            (iv) criminal activity not described in
                        clauses (i), (ii), and (iii); and
                            (v) involvement in gangs;
                    (C) promote personal and social responsibility
                among at-risk youth;
                    (D) encourage at-risk youth participation in
                community service and community activities; or
                    (E) provide general guidance to at-risk youth.
    (b) Amount and Duration.--Each grant under this section shall be
awarded in an amount not to exceed a total of $200,000 over a period of
not more than three years.
    (c) Priority.--The Secretary shall give priority to awarding a
grant under this section to an application submitted under section 7
that--
            (1) describes a mentoring program in which 60 percent or
        more of the at-risk youth to be served are eligible for
        assistance under part A of title I of the Elementary and
        Secondary Education Act of 1965 (20 U.S.C. 6311 et seq.);
            (2) describes a mentoring program that serves at-risk youth
        who are--
                    (A) at risk of dropping out of school; or
                    (B) involved in delinquent activities; and
            (3) demonstrates the ability of the eligible local
        educational agency to continue the mentoring program after the
        termination of the Federal funds provided under this section.
    (d) Other Considerations.--In awarding grants under this section,
the Secretary shall give consideration to--
            (1) providing an equitable geographic distribution of such
        grants, including awarding such grants for mentoring programs
        in both rural and urban areas;
            (2) the quality of the mentoring program described in the
        application submitted under section 7, including--
                    (A) the resources, if any, that will be dedicated
                to providing participating at-risk youth with
                opportunities for job training or postsecondary
                education; and
                    (B) the degree to which parents, teachers,
                community-based organizations, and the local community
                participate in the design and implementation of the
                mentoring program; and
            (3) the capability of the eligible local educational agency
        to effectively implement the mentoring program.

SEC. 4. IMPLEMENTATION AND EVALUATION GRANTS.

    The Secretary is authorized to award grants to national
organizations or agencies serving youth to enable such organizations or
agencies--
            (1) to conduct a multisite demonstration project, involving
        5 to 10 project sites, that--
                    (A) provides an opportunity to compare various one-
                to-one mentoring models for the purpose of evaluating
                the effectiveness and efficiency of such models;
                    (B) allows for innovative programs designed under
                the oversight of a national organization or agency
                serving youth, which programs may include--
                            (i) technical assistance;
                            (ii) training; and
                            (iii) research and evaluation; and
                    (C) disseminates the results of such demonstration
                project to allow for the determination of the best
                practices for various mentoring programs;
            (2) to develop and evaluate screening standards for school-
        linked mentoring programs; and
            (3) to develop and evaluate volunteer recruitment
        activities for school-linked mentoring programs.

SEC. 5. AUTHORIZED ACTIVITIES.

    (a) Permitted Uses.--Grant funds awarded under this Act (other than
grant funds awarded under section 4) shall be used for--
            (1) hiring of mentoring coordinators and support staff;
            (2) recruitment, screening and training of adult mentors;
            (3) reimbursement of mentors for reasonable incidental
        expenditures, such as transportation, that are directly
        associated with mentoring, except that such expenditures shall
        not exceed $500 per mentor per calendar year; or
            (4) such other purposes as the Secretary determines may be
        reasonable.
    (b) Prohibited Uses.--Grant funds awarded under this Act shall not
be used--
            (1) to directly compensate a mentor, except as provided
        under subsection (a)(3);
            (2) to obtain educational or other materials or equipment
        that would otherwise be used in the ordinary course of the
        grant recipient's operations;
            (3) to support litigation; or
            (4) for any other purposes that the Secretary determines
        are prohibited.
SEC. 6. REGULATIONS AND GUIDELINES.

    (a) Regulations.--The Secretary, after consultation with the
Secretary of Health and Human Services, the Attorney General, and the
Secretary of Labor, shall provide for the promulgation of regulations
to implement this Act.
    (b) Guidelines.--The Secretary shall develop and distribute to
eligible local educational agencies receiving a grant under section 3
specific model guidelines for the screening of mentors.

SEC. 7. APPLICATIONS.

    (a) In General.--Each entity desiring a grant under this Act shall
submit an application to the Secretary at such time, in such manner,
and accompanied by such information as the Secretary may reasonably
require.
    (b) Mentoring Programs.--Each application submitted under
subsection (a) for a grant under section 3 shall contain--
            (1) information on the at-risk youth expected to be served;
            (2) a provision describing the mechanism for matching at-
        risk youth with mentors based on the needs of the at-risk
        youth;
            (3) an assurance that no mentor will be assigned to more
        than one at-risk youth, so as to ensure a one-to-one mentoring
        relationship;
            (4) an assurance that a mentoring program operated in a
        secondary school will provide at-risk youth with a variety of
        experiences and support, including--
                    (A) an opportunity to spend time in a work
                environment and, when possible, participate in the work
                environment;
                    (B) an opportunity to witness the job skills that
                will be required for the at-risk youth to obtain
                employment upon graduation;
                    (C) assistance with homework assignments; and
                    (D) exposure to experiences that the at-risk youth
                might not otherwise encounter;
            (5) an assurance that the mentoring program operated in
        elementary schools will provide at-risk youth with--
                    (A) academic assistance;
                    (B) exposure to new experiences and activities that
                at-risk youth might not encounter on their own; and
                    (C) emotional support;
            (6) an assurance that the mentoring program will be
        monitored to ensure that each at-risk youth participating in
        the mentoring program benefits from a mentor relationship,
        including providing a new mentor assignment if the original
        mentoring relationship is not beneficial to the at-risk youth;
            (7) the methods by which mentors and at-risk youth will be
        recruited to the mentoring program;
            (8) the method by which prospective mentors will be
        screened; and
            (9) the training that will be provided to mentors.

SEC. 8. EVALUATION.

    (a) Evaluation.--The Comptroller General of the United States shall
enter into a contract, with an evaluating organization that has
demonstrated experience in conducting evaluations, for the conduct of
an ongoing rigorous evaluation of the programs and activities assisted
under this Act.
    (b) Evaluation Criteria.--The Comptroller General of the United
States, in consultation with the Secretary, shall establish minimum
criteria for evaluating the programs and activities assisted under this
Act. Such criteria shall provide for a description of the
implementation of each program or activity assisted under this Act and
such program or activity's effect on all participants, schools,
communities, and youth served by such program or activity.

SEC. 9. REPORTS.

    (a) Report by Grant Recipients.--Each entity receiving a grant
under this Act shall submit to the evaluating organization entering
into the contract under section 8(a)(1) an annual report regarding any
program or activity assisted under this Act. Each such report shall be
submitted at such a time, in such a manner, and accompanied by such
information, as such evaluating organization may require.
    (b) Reports by Comptroller General.--The Comptroller General shall
submit to Congress not later than September 30, 1999, a report
regarding the success and effectiveness of grants awarded under this
Act in reducing the school dropout rate, improving academic performance
of at-risk youth, and reducing juvenile delinquency and gang
participation.

SEC. 10. AUTHORIZATION OF APPROPRIATIONS.

    (a) Mentoring Programs.--There is authorized to be appropriated
$35,000,000 for each of the fiscal years 1996, 1997, 1998, 1999, and
2000 to carry out section 3.
    (b) Implementation and Evaluation Grants.--There is authorized to
be appropriated $5,000,000 for each of the fiscal years 1996, 1997,
1998, 1999, and 2000 to carry out section 4.

Summary: Character Development Act - Authorizes the Secretary of Education to award: (1) mentor program grants to eligible local educational agencies to establish mentoring programs designed to link individual at-risk youth with responsible, individual adults who serve as mentors. And (2) implementation and evaluation grants to national organizations or agencies serving youth to conduct a multisite demonstration project, involving five to ten project sites, develop and evaluate screening standards for school-linked mentoring programs, and develop and evaluate volunteer recruitment activities for school-linked mentoring programs. Sets forth permitted and prohibited uses of grant funds awarded under this Act. Directs the Secretary to develop and distribute to eligible local educational agencies receiving a mentor program grant specific model guidelines for the screening of mentors. Sets forth requirements for grant applications, program evaluations and reports by the Comptroller General, and reports by grant recipients. Authorizes appropriations for Mentoring Program Grants and Implementation and Evaluation Grants.

Character Development Act


SECTION 1. SHORT TITLE AND REFERENCE.

    (a) Short Title.--This Act may be cited as the ``Orphan Drug Act
Amendments of 1994 ''.
    (b) Reference.--Whenever in this Act (other than sections 5 and 6)
an amendment or repeal is expressed in terms of an amendment to, or
repeal of, a section or other provision, the reference shall be
considered to be made to a section or other provision of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 201 et seq.).

SEC. 2. PERIOD OF EXCLUSIVITY.

    (a) Initial Period.--Subsection (a) of section 527 (21 U.S.C.
360cc) is amended--
            (1) by inserting ``(1)'' after ``(a)'';
            (2) by redesignating paragraphs (1), (2), and (3) as
        subparagraphs (A), (B), and (C), respectively;
            (3) by striking ``seven years'' and inserting ``4 years'';
        and
            (4) by striking ``505(c)(2)'' and inserting
        ``505(c)(1)(B)''.
    (b) Additional Period.--Subsection (a) of section 527 (21 U.S.C.
360cc) (as amended by subsection (a)) is amended by adding at the end
the following new paragraphs:
    ``(2) The holder of the approved application, certification, or
license of a drug to which the 4-year period of exclusivity applies
under paragraph (1) may, after the expiration of 3\1/2\ years of such
period but not later than 90 days before the expiration of such period,
apply to the Secretary for a 3-year extension of such period. Such an
application shall contain such information as the Secretary determines
is necessary to evaluate such application.
    ``(3) The Secretary shall approve an application submitted under
paragraph (2) if the applicant--
            ``(A) demonstrates that the drug has a limited commercial
        potential as determined under regulations of the Secretary,
        taking into account sales information respecting such drug and
        any other factor identified by the Secretary in such
        regulations that is relevant to the commercial potential of
        such drug, and
            ``(B) makes such demonstration on the basis of the
        regulations of the Secretary referred to in subparagraph (A)
        that were in effect--
                    ``(i) on the date--
                            ``(I) such drug received its designation
                        under section 526(a), or
                            ``(II) such applicant applied for an
                        exemption for such drug under section 505(i) or
                        507(d),
                whichever first occurs, or
                    ``(ii) if the date under clause (i) occurred before
                the date such regulations were in effect, on the date
                such regulations were in effect.''.
    (c) Conforming Amendment.--Section 527(b) (21 U.S.C. 360cc(b)) is
amended--
            (1) by striking ``during the seven-year period beginning on
        the date of the application approval'' and inserting ``during
        the applicable period of exclusivity under subsection (a)'';
        and
            (2) by striking ``such seven year period'' and inserting
        ``the applicable period of exclusivity under subsection (a)''.
    (d) Effective Date.--The amendments made by subsections (a) and (b)
shall not apply to a drug--
            (1) for which an application under section 505 or 507 of
        the Federal Food, Drug, and Cosmetic Act or section 351 of the
        Public Health Service Act was submitted before March 1, 1994;
        or
            (2) for which an exemption under section 505(i) or 507(d)
        of the Federal Food, Drug, and Cosmetic Act was in effect
        before March 1, 1994, for which human clinical trials were
        actively being conducted before such date, and for which an
        application for designation under section 526 of such Act was
        submitted before the date of enactment of the Orphan Drug Act
        Amendments of 1994.
The 7 year period of exclusivity provided by section 527(a) of the
Federal Food, Drug, and Cosmetic Act before the date of the enactment
of this Act shall, after such date, apply to a drug described in
paragraph (1) or (2).
    (e) Regulations.--The Secretary shall issue final regulations to
implement paragraphs (2) and (3) of section 527(a) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360cc) (as amended by subsection (b))
not later than 6 months after the date of the enactment of this Act.

SEC. 3. DESIGNATIONS.

    (a) In General.--Section 526(a)(2) (21 U.S.C. 360bb(a)(2)) is
amended to read as follows:
    ``(2) For purposes of paragraph (1), the term `rare disease or
condition' means any disease or condition that--
            ``(A) affects fewer than 200,000 persons in the United
        States determined on the basis of--
                    ``(i) the facts and circumstances as of the date
                the request for designation of the drug under this
                subsection is made, and
                    ``(ii) projections as to the number of persons who
                will be affected by the disease or condition on a date
                which is 3 years from date such request was made, or
            ``(B) affects more than 200,000 persons in the United
        States and for which there is no reasonable expectation that
        the cost of developing and making available in the United
        States a drug for such disease or condition will be recovered
        from sales in the United States of such drug.''.
    (b) Exclusivity.--Section 527(b) (21 U.S.C. 360cc(b)) is amended--
            (1) in paragraph (1), by striking ``or'' at the end of such
        paragraph;
            (2) by striking the period at the end of paragraph (2) and
        inserting ``; or'', and
            (3) by adding at the end the following new paragraph:
            ``(3) a drug has been designated under section 526 for a
        rare disease or condition described in section 526(a)(2)(A) and
        if after such designation it is determined that--
                    ``(A) such disease or condition affects more than
                200,000 persons in the United States; and
                    ``(B) such drug does not meet the requirement of
                section 526(a)(2)(B).''.

SEC. 4. SIMULTANEOUS DEVELOPMENT.

    (a) In General.--Section 527(b) (21 U.S.C. 360cc(b)), as amended by
section 3(b), is amended by--
            (1) inserting ``(1)'' after ``(b)'';
            (2) by redesignating paragraphs (1), (2), and (3) as
        subparagraphs (A), (B), and (C), respectively;
            (3) by striking ``for a person who is not'' and inserting
        ``for an applicant who is not''; and
            (4) by adding at the end the following new subparagraphs:
            ``(D) the Secretary finds, after providing the holder, such
        applicant, and any other interested person an opportunity to
        present their views, that the drugs of the holder and such
        applicant were developed simultaneously.
The Secretary shall make a decision on a request for a finding under
subparagraph (D) not later than 60 days after the filing of the
request.
    ``(2) For purposes of paragraph (1)(D), drugs of a holder and an
applicant shall be considered to be developed simultaneously only if--
            ``(A) the applicant requested that its drug be designated
        under section 526 not later than 6 months after publication of
        the designation under section 526(c) of the holder's drug;
            ``(B) the applicant initiated the human clinical trials
        that the applicant relied on in its application for such
        approval, certification, or license not more than 12 months
        after the date the holder initiated the human clinical trials
        that the holder relied on in its application for such approval,
        certification, or license; and
            ``(C) the applicant submitted such application, including
        the reports of the clinical and animal studies necessary for
        approval, certification, or licensing, not more than 12 months
        after the holder submitted its application, including such
        reports, for such action.
    ``(3) Paragraph (1)(D) does not apply to a drug--
            ``(A) for which an application under section 505 or 507 or
        section 351 of the Public Health Service Act was submitted
        before March 1, 1994; or
            ``(B) for which an exemption under section 505(i) or 507(d)
        was in effect before March 1, 1994, for which human clinical
        trials were actively being conducted before such date, and for
        which an application for designation under section 526 was
        submitted before the date of enactment of the Orphan Drug Act
        Amendments of 1994.''.
    (b) Publication.--Section 526(c) (21 U.S.C. 360bb(c)) is amended--
            (1) by inserting ``for a rare disease or condition'' after
        ``(a)''; and
            (2) by striking ``shall be made available to the public''
        and inserting ``shall be promptly published in the Federal
        Register and otherwise made available to the public in a manner
        designed to notify persons who have such disease or
        condition''.

SEC. 5. OFFICE FOR ORPHAN DISEASES AND CONDITIONS.

    Section 227 of the Public Health Service Act (42 U.S.C. 236) is
amended--
            (1) in subsection (a), to read as follows:
    ``(a) There is established in the Department of Health and Human
Services an Office for Orphan Diseases and Conditions. Such Office
shall be established at a level within the Department with sufficient
authority to assure full implementation of the functions and
responsibilities established by this section.'';
            (2) by striking ``Board'' each place the term appears and
        inserting ``Office'';
            (3) in subsection (b), by striking ``drugs and devices''
        and inserting ``drugs, devices, and medical foods'';
            (4) in subsection (c)(1)(A), by inserting ``of chapter V''
        after ``subchapter B'';
            (5) by adding at the end the following new subsection:
    ``(f)(1) There is established in the Office an advisory committee
to advise the Office in carrying out the functions of the Office under
this section.
    ``(2) The advisory committee shall be comprised of 11 members
appointed by the Secretary, in consultation with the Office and the
Commissioner of the Food and Drug Administration, from persons
knowledgeable about rare diseases and conditions, including--
            ``(A) 5 representatives of organizations of persons with
        rare diseases or conditions;
            ``(B) 3 research scientists; and
            ``(C) 3 representatives of health-related companies.
    ``(3) The Secretary shall also appoint, as liaisons to the advisory
committee, individuals from the Food and Drug Administration, the
National Institutes of Health, and other appropriate Federal agencies.
    ``(4) Vacancies occurring in the membership of the advisory
committee shall be filled in the same manner as the original
appointment for the position being vacated. Vacancies shall not affect
the power of the remaining members to execute the duties of the
advisory committee.
    ``(5) Members of the advisory committee, and liaisons to the
advisory committee, shall not be compensated, but shall receive travel
expenses, including per diem in lieu of subsistence, at rates
authorized for employees of agencies under subchapter 1 of chapter 57
of title 5, United States Code, for each day the member or liaison is
engaged in the performance of duties away from the home or regular
place of business of the member or liaison.
    ``(6) Notwithstanding section 1342 of title 31, United States Code,
the advisory committee may accept the voluntary services provided by a
member of the advisory committee or a liaison to the advisory
committee.''; and
            (6) by amending the section heading to read as follows:

             ``office for orphan diseases and conditions''.

SEC. 6. AUTHORIZATION FOR ORPHAN DRUG ACT.

    Section 5(c) of the Orphan Drug Act (21 U.S.C. 360ee(c)) is amended
by striking ``$10,000,000'' and all that follows and inserting
``$20,000,000 for fiscal year 1995, $25,000,000 for fiscal year 1996,
and $30,000,000 for fiscal year 1997.''.

Summary: Orphan Drug Act Amendments of 1994 - Amends the Federal Food, Drug, and Cosmetic Act to change from seven to four years the period of market exclusivity guaranteed to any approved orphan drug. Specifies that orphan drugs of limited commercial potential, as defined by regulations to be issued by the Department of Health and Human Services, would qualify for an additional three years of exclusive marketing rights. Permits more than one company to put a particular orphan drug on the market in instances where both companies were working on the drug in roughly the same time frame. Provides for the withdrawal of exclusive marketing rights if the patient population for the approved treatment exceeds 200,000. Extends the authorization of the research grant program. Replaces the existing Orphan Products Board with an Office for Orphan Diseases and Conditions.

Orphan Drug Act Amendments of 1994


SECTION 1. SHORT TITLE.

    This Act may be cited as the ``E-Centives Act of 2009''.

SEC. 2. INCREASED MATCHING PAYMENTS UNDER MEDICAID FOR HEALTH
              INFORMATION TECHNOLOGY.

    Section 1903 of the Social Security Act (42 U.S.C. 1396b) is
amended--
            (1) in subsection (a)(3)(E), by inserting ``(other than
        costs attributable to programs described in subsection (bb))''
        after ``costs incurred during such quarter''; and
            (2) by adding at the end the following new subsections:
    ``(aa) Enhanced Payments for Certified Health Information
Technology Incentives.--
            ``(1) In general.--The Secretary shall provide for payments
        to each State that provides incentive payments to physicians,
        hospitals, community health centers, rural health clinics, and
        community mental health centers that exhibit meaningful use of
        health information technology certified under this subsection,
        as determined by the measures for meaningful use of health
        information technology under paragraph (5). No payment may be
        made to a State for incentive payments made by a State for
        meaningful use of health information technology that occurs
        before January 1, 2010.
            ``(2) Application.--To qualify for payments under paragraph
        (1), a State shall submit an application in a time and manner
        specified by the Secretary and containing the following:
                    ``(A) A description of the incentive payments.
                    ``(B) A description of the method the State will
                use to allocate such incentive payments among
                physicians, hospitals, community health centers, rural
                health clinics, and community mental health centers,
                including how the State will prioritize payments to
                providers serving a high percentage of Medicaid, SCHIP,
                and uninsured patients.
                    ``(C) A time line for implementing such payment
                incentives.
                    ``(D) A plan for disseminating information to
                physicians, hospitals, community health centers, rural
                health clinics, and community mental health centers
                about the availability of such payment incentives.
                    ``(E) An assessment of the current level of use of
                health information technology by physicians, hospitals,
                community health centers, rural health clinics, and
                community mental health centers in the State, using a
                standard assessment form developed by the Secretary.
                    ``(F) Any other information required by the
                Secretary.
            ``(3) Amount of payments to states.--
                    ``(A) In general.--Subject to subparagraph (B), the
                payment made to a State under this subsection for a
                quarter, with respect to sums expended by such State
                during such quarter that are attributable to providing
                incentive payments under paragraph (1), shall be in an
                amount equal to the following:
                            ``(i) For any quarter in 2010, the enhanced
                        FMAP (as defined in section 2105(b)) of such
                        sums.
                            ``(ii) For any quarter in 2011 or 2012,
                        such sums multiplied by a percentage equal to
                        such enhanced FMAP minus 1.5 percentage points.
                            ``(iii) For any quarter in 2013 or 2014,
                        such sums multiplied by a percentage equal to
                        such enhanced FMAP minus 3 percentage points.
                            ``(iv) For any quarter beginning after
                        2014, 0.
                    ``(B) Limitation.--
                            ``(i) Fiscal year limitation.--The total
                        amount of payments made under this subsection
                        shall not exceed $500,000,000 for any fiscal
                        year.
                            ``(ii) Allocation.--If the amounts
                        otherwise payable under this subsection for a
                        fiscal year exceed the amount specified in
                        clause (i), the Secretary shall reduce the
                        amounts payable under this subsection, in a
                        manner specified by the Secretary, to comply
                        with the limitation under such clause.
                            ``(iii) Duplicative payments prohibited.--
                        No payment shall be made under any other
                        provision of this title for expenditures for
                        which payment is made under this subsection.
                    ``(C) Manner of payment.--Payment to a State under
                this subsection shall be made in the same manner as
                payments under subsection (a).
            ``(4) Certification requirements for health information
        technology.--
                    ``(A) In general.--The Secretary, in consultation
                with the Office of the National Coordinator for Health
                Information Technology and the Certification Commission
                of Health Information Technology, shall determine the
                requirements for certification of health information
                technology under this subsection.
                    ``(B) Interim certification requirements.--During
                any period in which the Secretary has not determined
                such certification requirements, the Secretary, for
                purposes of this subsection, shall use the
                certification requirements for health information
                technology established by the Certification Commission
                for Health Information Technology.
            ``(5) Measures for meaningful use of health information
        technology.--
                    ``(A) In general.--For purposes of this subsection,
                the Secretary shall publish standard measures of
                meaningful use of health information technology to be
                used by providers to demonstrate meaningful use of
                certified health information technology. Such measures
                may include--
                            ``(i) self-certification of operational use
                        of such technology;
                            ``(ii) the submission of (or ability to
                        submit), in a form and manner specified by the
                        Secretary, such information on clinical
                        measures and data (that do not include
                        individually identifiable health information)
                        from such technology as indicates a meaningful
                        utilization of such technology; and
                            ``(iii) such other means as the Secretary
                        may specify.
                    ``(B) Alternative measures.--The Secretary may
                establish and apply different measures based on the
                stage of implementation or adoption of the certified
                health information technology involved.
    ``(bb) Payments for Electronic Information and Eligibility Systems
and Patient Registries.--
            ``(1) In general.--In addition to the payments provided
        under subsection (a), the Secretary shall provide for payments
        to each State that establishes a program to--
                    ``(A) design, develop, install, maintain, and
                operate--
                            ``(i) electronic information and
                        eligibility systems; and
                            ``(ii) patient registries for the purpose
                        of disease screening;
                    ``(B) coordinate benefits and services under this
                title and under title XVIII for individuals under the
                State plan who are full-benefit dual eligible
                individuals.
                    ``(C) train providers in the use of such systems
                and registries.
            ``(2) Application.--To qualify for payments under paragraph
        (1), a State shall submit an application in such time and
        manner as required by the Secretary and containing such
        information as the Secretary specifies and include, at a
        minimum, a description of the electronic information and
        eligibility systems and patient registries covered by the
        program described in paragraph (1).
            ``(3) Amount of payments to states.--
                    ``(A) In general.--The payments made a State under
                this subsection shall be an amount equal to--
                            ``(i) 90 percent of so much of the sums
                        expended by such State during any quarter
                        commencing on or after January 1, 2010, as are
                        attributable to--
                                    ``(I) the design, development, or
                                installation of electronic information
                                and eligibility systems and patient
                                registries under paragraph (1); and
                                    ``(II) training staff employed by
                                providers on the use of such system or
                                registry during the three-year period
                                beginning on the date such system or
                                registry is installed; and
                            ``(ii) 75 percent of so much of the sums
                        expended by such State during any quarter
                        commencing on or after January 1, 2010, as are
                        attributable to--
                                    ``(I) the maintenance of such
                                systems and registries; and
                                    ``(II) training for staff employed
                                by providers on the use of a system or
                                registry that occurs after the last day
                                of the end of the period described in
                                clause (i)(II).
                    ``(B) Manner of payment.--Payment to a State under
                this subsection shall be made in the same manner as
                payments under subsection (a).
            ``(4) Electronic information and eligibility system
        defined.--For purposes of this subsection, the term `electronic
        information and eligibility system' means a system for
        determining eligibility and exchanging information that meets
        such requirements as the Secretary shall specify. Such
        requirements for a system shall include a requirement that the
        system--
                    ``(A) be interconnected and interoperable with
                other electronic systems and registries, including--
                            ``(i) systems administered by the Centers
                        for Disease Control for disease reporting
                        purposes;
                            ``(ii) systems that exist for the purpose
                        of determining eligibility for the Medicare
                        program under title XVIII; and
                            ``(iii) systems that exist for the purpose
                        of determining eligibility for the Temporary
                        Assistance for Needy Families program under
                        title IV, free and reduced price lunches under
                        the Richard B. Russell National School Lunch
                        Act (42 U.S.C. 1751 et seq.), or other
                        federally funded programs targeted to low-
                        income populations; and
                    ``(B) can be used to automatically send, receive,
                and integrate data (including laboratory results and
                medical histories) from systems and registries
                administered by other providers or organizations or
                through a health information exchange.''.

SEC. 3. MEDICAID TRANSFORMATION PAYMENTS REPORT.

    (a) In General.--Not later than June 30, 2009, the Secretary of
Health and Human Services shall submit to Congress a report on Medicaid
transformation payments under section 1903(z) of the Social Security
Act (42 U.S.C. 1396b(z)).
    (b) Contents.--The report under subsection (a) shall include--
            (1) a description--
                    (A) of the financial costs and benefits of the
                Medicaid transformation payments;
                    (B) of the entities to which such costs and
                benefits accrue; and
                    (C) of any reduction in duplicative or unnecessary
                care resulting from methods adopted by States and
                funded by such payments; and
            (2) an analysis of the information contained in the reports
        submitted to the Secretary by States under section
        1903(z)(3)(C) of the Social Security Act during the two-year
        period ending on December 31, 2008, including--
                    (A) the impact of the methods funded by the
                payments on--
                            (i) health care quality and safety; and
                            (ii) the privacy and security of
                        identifiable health information;
                    (B) the effect of such methods on furthering
                interconnectedness between--
                            (i) providers and State Medicaid programs;
                        and
                            (ii) State Medicaid programs and other
                        programs for low-income populations
                        administered by State and Federal entities;
                    (C) the extent to which such methods reduce the
                administrative burden on such programs; and
                    (D) the contribution of the payments to the goals
                of public health and public health reporting.

Summary: E-Centives Act of 2009 - Amends title XIX (Medicaid) of the Social Security Act to direct the Secretary of Health and Human Services to provide for payments to each state that provides incentive payments to physicians, hospitals, community health centers, rural health clinics, and community mental health centers that exhibit meaningful use of certified health information technology. Directs the Secretary to provide for payments to each state that establishes a program to: (1) design, develop, install, maintain, and operate electronic information and eligibility systems and patient registries for the purpose of disease screening. (2) coordinate benefits and services under Medicare and Medicaid for full-benefit dual eligible individuals under the state plan. And (3) train providers in the use of such systems and registries. Directs the Secretary of Health and Human Services to submit to Congress a report on Medicaid transformation payments to states for the adoption of innovative methods to improve effectiveness and efficiency in providing medical assistance.

A bill to amend title XIX of the Social Security Act to encourage the use of certified health information technology by providers in the Medicaid program and the Children's Health Insurance Program, and for other purposes.


SECTION 1. SHORT TITLE.

    This Act may be cited as the ``National Guard Investigations
Transparency and Improvement Act of 2014''.

SEC. 2. CODIFICATION IN LAW OF ESTABLISHMENT AND DUTIES OF THE OFFICE
              OF COMPLEX ADMINISTRATIVE INVESTIGATIONS IN THE NATIONAL
              GUARD BUREAU.

    (a) In General.--There is in the Office of the Chief of the
National Guard Bureau the Office of Complex Administrative
Investigations (in this section referred to as the ``Office'').
    (b) Direction and Supervision.--The Office shall be under the
direction and supervision of the Chief of the National Guard Bureau.
    (c) Duties.--
            (1) In general.--The duties of the Office shall be to
        undertake complex administrative investigations of matters
        relating to members of the National Guard when in State status,
        including investigations of sexual assault involving a member
        of the National Guard in such status, upon the request of any
        of the following:
                    (A) The Chief of the National Guard Bureau.
                    (B) An adjutant general of a State or territory or
                the District of Columbia.
                    (C) The governor of a State or territory, or the
                Commanding General of the National Guard of the
                District of Columbia.
            (2) Complex administrative investigations.--For purposes of
        this subsection, a complex administrative investigation is any
        investigation (as specified by the Chief of the National Guard
        Bureau for purposes of this section) involving factors giving
        rise to unusual complexity in investigation, including the
        following:
                    (A) Questions of jurisdiction between the United
                States and a State or territory.
                    (B) Matters requiring specialized training among
                investigating officers.
                    (C) Matters raising the need for an independent
                investigation in order to ensure fairness and
                impartiality in investigation.
            (3) Matters relating to members of the national guard in
        state status.--The determination whether or not a matter
        relates to a member of the National Guard when in State status
        for purposes of this section shall be made by the Chief of the
        National Guard Bureau in accordance with criteria specified by
        the Chief of the National Guard Bureau for purposes of this
        section.
    (d) Chief of National Guard Bureau Treatment of Final Reports.--The
Chief of the National Guard Bureau shall treat any final report of the
Office on a matter under this section as if such report were the report
of an Inspector General of the Department of Defense or a military
department on such matter.
    (e) Reports to Congress.--
            (1) Submittal of final reports to congressional
        delegations.--Upon the adoption by the Office of a final report
        on an investigation undertaken by the Office pursuant to this
        section, the Chief of the National Guard Bureau shall submit
        such report (with any personally identifying information
        appropriately redacted) to the members of Congress from the
        State or territory concerned.
            (2) Annual reports.--The Chief of the National Guard Bureau
        shall submit to Congress each year a report on the
        investigations undertaken by the Office pursuant to this
        section during the preceding year. Each report shall include,
        for the year covered by such report, the following:
                    (A) A summary description of the investigations
                undertaken during such year, including any trends in
                matters subject to investigation and in findings as a
                result of investigations.
                    (B) Information, set forth by State and territory,
                on the investigations undertaken during such year
                involving allegations of sexual assault involving a
                member of the National Guard.
                    (C) Such other information and matters on the
                investigations undertaken during such year as the Chief
                of the National Guard Bureau considers appropriate.
    (f) Personnel and Other Capabilities.--The Chief of the National
Guard Bureau shall ensure that the Office maintains the personnel and
other capabilities necessary for the discharge of the duties of the
Office under this section.
    (g) Procedures and Instructions.--The Chief of the National Guard
Bureau shall issue, and may from time to time update, procedures and
instructions necessary for the discharge of the duties of the Office
under this section.
    (h) Repeal of Superseded Instruction.--Chief of the National Guard
Bureau Instruction CNGBI 0400.01, dated July 30, 2012, shall have no
further force or effect.

Summary: National Guard Investigations Transparency and Improvement Act of 2014 - Codifies the establishment of the Office of Complex Administrative Investigations in the Office of the Chief of the National Guard Bureau. Requires the Office to undertake complex administrative investigations of matters relating to members of the National Guard when in state status, including investigations of sexual assault, upon the request of: (1) the Chief. (2) an adjutant general of a state, a territory, or the District of Columbia, (3) a governor of a state or territory. Or (4) the Commanding General of the National Guard of the District of Columbia. Defines quot, complex administrative investigationquot. As any investigation specified by the Chief involving factors giving rise to unusual complexity, including: (1) questions of jurisdiction between the United States and a state or territory, (2) matters requiring specialized training among investigating officers, or (3) matters raising the need for an independent investigation to ensure fairness and impartiality. Requires the Chief to treat any final report of the Office relating to such matters as if it were the report of an inspector general of the Department of Defense (DOD) or a military department. Directs the Chief to submit to Members of Congress from the state or territory concerned the final report adopted by the Office regarding such an investigation. Requires the Chief to submit to Congress an annual report regarding all investigations undertaken by the Office during the preceding year.


SECTION 1. SHORT TITLE.

     This Act may be cited as the ``Department of Veterans Affairs
Claims Backlog Reduction Act of 2002''.

SEC. 2. FINDINGS.

     Congress finds the following:
            (1) There are over 25,000,000 honorably discharged veterans
        of the Armed Forces of the United States.
            (2) There are over 500,000 veterans who have claims pending
        with the Department of Veterans Affairs for veterans' benefits,
        and approximately 100,000 of such claims are over one year old
        without resolution.
            (3) The Nation's veterans are dying at a rate of over 1,000
        veterans a day.
            (4) It is the responsibility of the United States
        Government to live up to the promises to the Nation's veterans
        that were made and accepted.
            (5) The National Association of County Veterans Service
        Officers is an organization that includes approximately 2,400
        full-time employees and whose members are present in 37 States.
            (6) Members of the National Association of County Veterans
        Service Officers stand ready to partner with the Department of
        Veterans Affairs in order to eliminate the backlog of claims
        for veterans' benefits.

SEC. 3. DEFINITIONS.

     In this Act:
            (1) The term ``claimant'' means an individual applying for,
        or submitting a claim for, any benefit under the laws
        administered by the Secretary of Veterans Affairs.
            (2) The term ``County Veterans Service Officer'' means any
        person employed by or funded by any county, parish, borough, or
        territory whose job it is to assist veterans and eligible
        dependents in the application for, administration of, or
        receipt of benefits under any Federal, State, or County
        veterans' benefit program.
            (3) The term ``injury or illness claim'' means a claim for
        benefits that is documented as being service-connected.
            (4) The term ``presumptive claim'' means a claim for
        benefits that is presumptively connected to a specific tour of
        duty or to specific types of military assignment.
            (5) The term ``statutory claims'' means those claims for
        benefits defined in section 5101 of title 38, United States
        Code.
            (6) The term ``specific claims'' includes statutory claims,
        presumptive claims, and injury or illness claims.
            (7) The term ``ready to be rated'' means that there is
        sufficient information to evaluate the claimed disability and
        to assign a rating based on degree of disability.
            (8) The term ``State'' has the meaning given that term in
        section 101(20) of title 38, United States Code.

SEC. 4. REDUCTION OF BACKLOG OF VETERANS' CLAIMS.

    (a) Referral of Claims to County Veterans Service Officers.--
            (1) The Secretary of Veterans Affairs shall identify the
        backlog of veterans' claims as of the date of the enactment of
        this Act and shall categorize those claims into types of
        specific claims. As part of such categorization, the Secretary
        shall identify the pending claims that require development. The
        Secretary shall refer those claims requiring development to a
        County Veterans Service Office for development.
            (2) The Secretary shall choose a County Veterans Service
        Office for development of a claim based upon the office's
        geographical proximity to the claimant.
            (3) A claim referred to a County Veterans Service Office
        for development shall be accompanied by specification from the
Secretary of the information that is required to develop the claim and
the information that is needed to make the claim ready to rate.
    (b) Filing of Claims With County Veterans Service Officers.--Claims
for benefits under laws administered by the Secretary of Veterans
Affairs may be submitted to County Veterans Service Officers. Receipt
of such a claim by a County Veterans Service Officer under this Act
shall be treated for all purposes as receipt of the claim by the
Secretary of Veterans Affairs.

SEC. 5. DEVELOPMENT OF CLAIMS.

    (a) Development of Claims by County Veterans Service Officer.--When
a County Veterans Service Officer receives a claim referred under
section 4(a) or receives a claim under section 4(b), that officer shall
make personal contact with the claimant, explain the situation, and
develop the claim.
    (b) Authority to Fully Develop Claim.--A County Veterans Service
Officer to whom a claim is referred under section 4(a) or receives a
claim under section 4(b) shall have the authority to fully develop the
claim and to transmit the claim to the Secretary of Veterans Affairs
when the claim is ready to be rated.
    (c) Procedure.--Once the claim has been fully developed, the claim
shall be transmitted back to the Secretary with the information
developed in accordance with the specification under section 3(a)(3)
and a statement from the County Veterans Service Officer indicating
that the claim is ready to rate.
    (d) Fully Developed Claims.--For purposes of this section, a claim
shall be considered to be fully developed when the County Veterans
Service Officer has obtained all items that that officer determines are
necessary to substantiate the claim and all items that the Secretary of
Veterans Affairs has specifically specified to be developed in
connection with the claim.

SEC. 6. INFORMATION SHARING.

     Veterans' information contained in the Benefits Delivery Network
of the Department of Veterans Affairs shall be accessible to County
Veterans Service Offices in order to provide County Veterans Service
Offices with online access to client information contained in the
Department of Veterans Affairs database. Such information shall be used
by such offices to develop veterans' claims under this Act and for no
other purpose.

SEC. 7. ALLOCATION OF FUNDS.

    (a) In General.--Funding for purposes of this Act shall be
allocated by grant to the States based on the population of veterans in
the respective States. Funds allocated to a State under this Act shall
be directed to County Veterans Service Offices within the State through
the State Department of Veterans Affairs (or the equivalent).
    (b) State Overhead.--A State Department of Veterans Affairs may
retain from any such grant for any fiscal year an amount equal to the
expenses incurred by that State for administrative overhead in
administering grants for that year, except that the amount so retained
in any fiscal year may not exceed 3 percent of the amount of the grant
to that State for that fiscal year.
    (c) Funds for Education and Training.--A portion of the funding
received by a State under this Act for any fiscal year, as determined
by the Secretary of Veterans Affairs in agreement with County Veterans
Service Offices, shall be used for County Veterans Service Officers to
attend educational programs sponsored by or equivalent to the National
Association of County Veterans Service Officers annual continuing
education and accreditation training.
    (d) Limitation on Federal Funding.--Federal funds under this Act
may not be used to provide more than 50 percent of the total costs for
County Veterans Service Offices and shall be used to expand existing
programs, not to supplant existing local government funding.
    (e) Establishment of New Cvso Programs.--(1) In the case of a State
that as of the date of the enactment of this Act does not have a County
Veterans Service Officer program, Federal funding under this Act may be
used by units of local government to establish such a program to assist
veterans and their dependents in filing applications for veterans
benefits and for the purposes specified in this Act.
    (2) In a State covered by paragraph (1), if a unit of local
government chooses not to establish a County Veterans Service Officers
program as described in that paragraph, the State department of
veterans affairs (or the equivalent) may elect to perform the services
as specified in this Act for that State.
    (3) In a State covered by paragraph (1), if both units of local
government and the State government elect not to use some or all of the
funds, the unused amount shall revert back to the Secretary of Veterans
Affairs and shall be reallocated to those State department of veterans
affairs (or the equivalent) in which County Veterans Service Officers
programs exist to further expand services to veterans in those States
in support of the veterans claims backlog reduction services under this
Act.

SEC. 8. AUTHORIZATION OF APPROPRIATIONS.

     There are authorized to be appropriated to the Secretary of
Veterans Affairs to carry out this Act $70,000,000 for each of fiscal
years 2003, 2004, and 2005.

Summary: Department of Veterans Affairs Claims Backlog Reduction Act of 2002 - Directs the Secretary of Veterans Affairs to: (1) identify the current backlog of veterans' claims for benefits through the Department of Veterans Affairs and to categorize those claims. And (2) identify claims that need further development and refer them to a geographically appropriate County Veterans Service Office. Allows veterans' claims to be submitted to County Veterans Service Officers and authorizes the Officers to fully develop such claims. Requires appropriate information sharing between the Department's Benefits Delivery Network and the Offices. Requires funding provided by this Act to be allocated to States based on their respective populations of veterans and allocates such funds to the appropriate Office. Prohibits Federal funding from exceeding 50 percent of the costs of Office operations. Allows funding to be used to establish Officer programs in States that do not have one.

To provide for reduction in the backlog of claims for benefits pending with the Department of Veterans Affairs.