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<amendment-doc dms-id="HAFBC0925B0914107874C4928637C898B" amend-stage="proposed" amend-type="house-amendment" amend-degree="first" key="H"> 
<pre-form><meta-house><holc-filename>G:\CMTE\RU\15\RCP\RCP6082.XML</holc-filename><holc-attorney>XXXXXXX</holc-attorney><holc-last-author>XXXXXXXX</holc-last-author><holc-last-saved>6/13/2018 15:02</holc-last-saved><holc-creator>XXXXXXXX</holc-creator><holc-creation-date>06/13/2018 14:51</holc-creation-date><version><version-filename>XXXXXXXXXXXXXXXXXXXXXXXXXXXXX</version-filename><version-date>XXXXXXXXXXXXXXXXXXX</version-date><version-creator>XXXXXXXX</version-creator></version> <holc-job-number/><holc-doc-number>699068|1</holc-doc-number> </meta-house> 
<author-note display="no"><?xm-replace_text {author-note}?></author-note> 
<running-header display="no">[Discussion Draft]</running-header> 
<legis-counsel/> 
<first-page-header display="no">[Discussion Draft]</first-page-header> 
<first-page-date display="yes">June 13, 2018</first-page-date> 
<first-page-desc display="no"><?xm-replace_text {first-page-desc}?></first-page-desc> 
</pre-form> 
<amendment-form> 
<purpose display="no"><?xm-replace_text {purpose}?></purpose> 
<congress display="no">115th CONGRESS</congress> <session display="no">2d Session</session> 
<legis-num>Rules Committee Print 115–75</legis-num> 
<action> 
<action-desc>Text of H.R. 6082, Overdose Prevention and Patient Safety Act</action-desc> 
<action-desc blank-lines-after="1" display="no">Offered by M_. ______</action-desc> 
<action-instruction>[Showing the text of H.R. 6082, as introduced]</action-instruction> 
</action> 
</amendment-form> 
<amendment-body> <amendment> 
<amendment-instruction line-numbers="off"><text><?xm-replace_text {amendment-instruction}?></text></amendment-instruction> 
<amendment-block style="OLC" id="H9F93CF6122CB4EA1A432B3B1C7681A45"> 
<section id="H05F3E5449D15418FA9952404421F4EC6" section-type="section-one"><enum>1.</enum><header>Short title</header><text display-inline="no-display-inline">This Act may be cited as the <quote>Overdose Prevention and Patient Safety Act</quote>. </text></section> 
<section id="H16CD2A1CB98E45CAB6B8590C27267553"><enum>2.</enum><header>Confidentiality and disclosure of records relating to substance use disorder</header> 
<subsection id="H301FEE558BDA4B7F94BB6B4D6778C60E" commented="no"><enum>(a)</enum><header>Conforming changes relating to substance use disorder</header><text>Subsections (a) and (h) of section 543 of the Public Health Service Act (42 U.S.C. 290dd–2) are each amended by striking <quote>substance abuse</quote> and inserting <quote>substance use disorder</quote>.</text></subsection> 
<subsection id="H1DE9B80A03BF4A84A09DFA6554BAC6A7"><enum>(b)</enum><header>Disclosures to covered entities consistent with HIPAA</header><text display-inline="yes-display-inline">Paragraph (2) of section 543(b) of the Public Health Service Act (42 U.S.C. 290dd–2(b)) is amended by adding at the end the following:</text> 
<quoted-block style="OLC" id="H0CD0845FA1FA4D45ADA0E08E3A02A92A" display-inline="no-display-inline"> 
<subparagraph id="H9FEA05BB0D7D49599B7BB0CC8964986B" commented="no"><enum>(D)</enum><text display-inline="yes-display-inline">To a covered entity or to a program or activity described in subsection (a), for the purposes of treatment, payment, and health care operations, so long as such disclosure is made in accordance with HIPAA privacy regulation. Any redisclosure of information so disclosed may only be made in accordance with this section.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection> 
<subsection id="H6564B0609A7546D684C9DE6A690370A2"><enum>(c)</enum><header>Disclosures of de-identified health information to public health authorities</header><text>Paragraph (2) of section 543(b) of the Public Health Service Act (42 U.S.C. 290dd–2(b)), as amended by subsection (b), is further amended by adding at the end the following:</text> 
<quoted-block style="OLC" id="H5D2BAC3FE1E44F52AA648C9A0DD4C01D" display-inline="no-display-inline"> 
<subparagraph id="H632FB2B5079F44B3B40FE218ED9CAEDA"><enum>(E)</enum><text display-inline="yes-display-inline">To a public health authority, so long as such content meets the standards established in section 164.514(b) of title 45, Code of Federal Regulations (or successor regulations) for creating de-identified information.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection> 
<subsection id="H5252936A5EAE4624A5B13B5AFAB317F4"><enum>(d)</enum><header>Definitions</header><text display-inline="yes-display-inline">Subsection (b) of section 543 of the Public Health Service Act (42 U.S.C. 290dd–2) is amended by adding at the end the following:</text> 
<quoted-block style="OLC" id="HCA3D15ED160640D0B8C1358D13962BB5" display-inline="no-display-inline"> 
<paragraph id="H11E106DF55BB4DC68F97A5EAC9D940F0"><enum>(3)</enum><header>Definitions</header><text>For purposes of this subsection:</text> 
<subparagraph id="H1B2BF385808D4ADBBF0A3E5987FC4B1D"><enum>(A)</enum><header>Covered entity</header><text>The term <quote>covered entity</quote> has the meaning given such term for purposes of HIPAA privacy regulation.</text></subparagraph> 
<subparagraph id="H9A570FE23CEA4F35947F282965AC6B17" commented="no"><enum>(B)</enum><header>Health care operations</header><text>The term <quote>health care operations</quote> has the meaning given such term for purposes of HIPAA privacy regulation.</text></subparagraph> 
<subparagraph id="H15ADB2642DB7422EB2BC3C668379BFB0"><enum>(C)</enum><header>HIPAA privacy regulation</header><text>The term <quote>HIPAA privacy regulation</quote> has the meaning given such term under section 1180(b)(3) of the Social Security Act.</text></subparagraph> 
<subparagraph id="H12B47F53D0A0400DAC647CCDD7C1B99D"><enum>(D)</enum><header>Individually identifiable health information</header><text>The term <quote>individually identifiable health information</quote> has the meaning given such term for purposes of HIPAA privacy regulation.</text></subparagraph> 
<subparagraph id="H261B0D8C86AE42A6B6A1B8A2ADECD5F8" commented="no"><enum>(E)</enum><header>Payment</header><text>The term <quote>payment</quote> has the meaning given such term for purposes of HIPAA privacy regulation.</text></subparagraph> 
<subparagraph id="H2BB924DBABD447E4A8393AA26CC50671"><enum>(F)</enum><header>Public health authority</header><text display-inline="yes-display-inline">The term <quote>public health authority</quote> has the meaning given such term for purposes of HIPAA privacy regulation. </text></subparagraph> 
<subparagraph id="HACDF11B46CAA41CA9739816651DB3204" commented="no"><enum>(G)</enum><header>Treatment</header><text display-inline="yes-display-inline">The term <quote>treatment</quote> has the meaning given such term for purposes of HIPAA privacy regulation.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection> 
<subsection id="H58D31E16502C48E6AB2949C90896FEC6"><enum>(e)</enum><header>Use of records in criminal, civil, or administrative investigations, actions, or proceedings</header><text display-inline="yes-display-inline">Subsection (c) of section 543 of the Public Health Service Act (42 U.S.C. 290dd–2) is amended to read as follows:</text> 
<quoted-block style="OLC" id="HE0A613E70C854BC8984200B9E02FBEE1" display-inline="no-display-inline"> 
<subsection id="H8C76F5C2D2454125A4E3D955773EBEF0"><enum>(c)</enum><header>Use of records in criminal, civil, or administrative contexts</header><text>Except as otherwise authorized by a court order under subsection (b)(2)(C) or by the consent of the patient, a record referred to in subsection (a) may not—</text> 
<paragraph id="H2174F1E6E92541BE889CB07DF117BF73"><enum>(1)</enum><text>be entered into evidence in any criminal prosecution or civil action before a Federal or State court; </text></paragraph> 
<paragraph id="HFBBF16ED61EA4B7087BDBAE294282C74"><enum>(2)</enum><text>form part of the record for decision or otherwise be taken into account in any proceeding before a Federal agency; </text></paragraph> 
<paragraph id="H0829A53124C1478B93DE15E278A4E371" commented="no"><enum>(3)</enum><text>be used by any Federal, State, or local agency for a law enforcement purpose or to conduct any law enforcement investigation of a patient; or</text></paragraph> 
<paragraph id="HC6E6FC24798D4EFCBEDB24F0709D0D1D"><enum>(4)</enum><text>be used in any application for a warrant.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection> 
<subsection id="H850B6507A08546FABA5A8225176B9EA8"><enum>(f)</enum><header>Penalties</header><text>Subsection (f) of section 543 of the Public Health Service Act (42 U.S.C. 290dd–2) is amended to read as follows:</text> 
<quoted-block style="OLC" id="HC3A93B27538E44F8AF14DAEDCA1E019D" display-inline="no-display-inline"> 
<subsection id="H05838A3AE4A04A20876D55D7461FCAA2"><enum>(f)</enum><header>Penalties</header><text display-inline="yes-display-inline">The provisions of sections 1176 and 1177 of the Social Security Act shall apply to a violation of this section to the extent and in the same manner as such provisions apply to a violation of part C of title XI of such Act. In applying the previous sentence—</text> 
<paragraph id="H5D3BCE6BCD244728A98B32C190B8DD47"><enum>(1)</enum><text>the reference to <quote>this subsection</quote> in subsection (a)(2) of such section 1176 shall be treated as a reference to <quote>this subsection (including as applied pursuant to section 543(f) of the Public Health Service Act)</quote>; and</text></paragraph> 
<paragraph id="HAC5652E844734FA9AEDCDB03934BF883"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (b) of such section 1176—</text> 
<subparagraph id="HD2059C36F72B4622AE022E55D88AD016"><enum>(A)</enum><text>each reference to <quote>a penalty imposed under subsection (a)</quote> shall be treated as a reference to <quote>a penalty imposed under subsection (a) (including as applied pursuant to section 543(f) of the Public Health Service Act)</quote>; and</text></subparagraph> 
<subparagraph id="H36E2874240EB4D8ABE2EECE0D53A8DFF"><enum>(B)</enum><text>each reference to <quote>no damages obtained under subsection (d)</quote> shall be treated as a reference to <quote>no damages obtained under subsection (d) (including as applied pursuant to section 543(f) of the Public Health Service Act)</quote>.</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection> 
<subsection id="HD21D944D3DB74A64B229616AC9D8F29B"><enum>(g)</enum><header>Antidiscrimination</header><text display-inline="yes-display-inline">Section 543 of the Public Health Service Act (42 U.S.C. 290dd–2) is amended by adding at the end the following:</text> 
<quoted-block style="OLC" id="H238E7E6738EF45A5B3A647A304459FDC" display-inline="no-display-inline"> 
<subsection id="H0E9EF71C699C424B8199C0BDD600F992"><enum>(i)</enum><header>Antidiscrimination</header> 
<paragraph id="H45718002285146DD80DC14F8E21C145D"><enum>(1)</enum><header>In general</header><text>No entity shall discriminate against an individual on the basis of information received by such entity pursuant to a disclosure made under subsection (b) in—</text> 
<subparagraph id="HC110B6F4EDE84852B2A115A60C7C2875"><enum>(A)</enum><text>admission or treatment for health care;</text></subparagraph> 
<subparagraph id="H6746602D14474B789C1B37EBDCFF4649"><enum>(B)</enum><text>hiring or terms of employment;</text></subparagraph> 
<subparagraph id="H5EA3E83DE2B54F8488A2A1048C87BB1A"><enum>(C)</enum><text>the sale or rental of housing; or</text></subparagraph> 
<subparagraph id="H1B943A31C7214B87A8348E1ABD7A5623"><enum>(D)</enum><text>access to Federal, State, or local courts.</text></subparagraph></paragraph> 
<paragraph id="HA92CA191EB0B453ABDF317DC4C3F7E25"><enum>(2)</enum><header>Recipients of Federal funds</header><text display-inline="yes-display-inline">No recipient of Federal funds shall discriminate against an individual on the basis of information received by such recipient pursuant to a disclosure made under subsection (b) in affording access to the services provided with such funds.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection> 
<subsection id="H05C92C0D98A44E348C9FF7246643B4C0" commented="no"><enum>(h)</enum><header>Notification in case of breach</header><text display-inline="yes-display-inline">Section 543 of the Public Health Service Act (42 U.S.C. 290dd–2), as amended by subsection (g), is further amended by adding at the end the following:</text> 
<quoted-block style="OLC" id="H83B20A3FB89A4AA3BC06FA9E660280F6" display-inline="no-display-inline"> 
<subsection id="H04CE0D2FCFC04AA9B83B5753241B46F9" commented="no"><enum>(j)</enum><header>Notification in case of breach</header> 
<paragraph id="HF32CA44ADC5F4B3C8641CE7FCD487B07" commented="no"><enum>(1)</enum><header>Application of HITECH notification of breach provisions</header><text>The provisions of section 13402 of the HITECH Act (42 U.S.C. 17932) shall apply to a program or activity described in subsection (a), in case of a breach of records described in subsection (a), to the same extent and in the same manner as such provisions apply to a covered entity in the case of a breach of unsecured protected health information.</text></paragraph> 
<paragraph id="HBC002410D0FB4701B08B890D001E86C8" commented="no"><enum>(2)</enum><header>Definitions</header><text>In this subsection, the terms <quote>covered entity</quote> and <quote>unsecured protected health information</quote> have the meanings given to such terms for purposes of such section 13402.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection> 
<subsection id="H4C2EF4051B6844AA8150F681CC6EDAB4"><enum>(i)</enum><header>Sense of Congress</header><text display-inline="yes-display-inline">It is the sense of the Congress that any person treating a patient through a program or activity with respect to which the confidentiality requirements of section 543 of the Public Health Service Act (42 U.S.C. 290dd–2) apply should access the applicable State-based prescription drug monitoring program as a precaution against substance use disorder.</text></subsection> 
<subsection id="H092AB905E5554392A031AA0F19CF9413"><enum>(j)</enum><header>Regulations</header> 
<paragraph id="H336588C1611C496EB87CBC83656E8538"><enum>(1)</enum><header>In general</header><text>The Secretary of Health and Human Services, in consultation with appropriate Federal agencies, shall make such revisions to regulations as may be necessary for implementing and enforcing the amendments made by this section, such that such amendments shall apply with respect to uses and disclosures of information occurring on or after the date that is 12 months after the date of enactment of this Act.</text></paragraph> 
<paragraph id="HBE11C3D57B5140BFB4F32BA9DB91F635"><enum>(2)</enum><header>Easily understandable notice of privacy practices</header><text display-inline="yes-display-inline">Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, in consultation with appropriate experts, shall update section 164.520 of title 45, Code of Federal Regulations, so that covered entities provide notice, written in plain language, of privacy practices regarding patient records referred to in section 543(a) of the Public Health Service Act (42 U.S.C. 290dd–2(a)), including—</text> 
<subparagraph id="H4D9C80F9D98647108B32C2C7FD97F5D7"><enum>(A)</enum><text display-inline="yes-display-inline">a statement of the patient’s rights, including self-pay patients, with respect to protected health information and a brief description of how the individual may exercise these rights (as required by paragraph (b)(1)(iv) of such section 164.520); and</text></subparagraph> 
<subparagraph id="H5AAF02872A814EC6AC4288CC0F83A7B8"><enum>(B)</enum><text display-inline="yes-display-inline">a description of each purpose for which the covered entity is permitted or required to use or disclose protected health information without the patient’s written authorization (as required by paragraph (b)(2) of such section 164.520).</text></subparagraph></paragraph></subsection> 
<subsection id="HA6062B9AD6074379ADB143A05B67D1D7"><enum>(k)</enum><header>Development and dissemination of model training programs for substance use disorder patient records</header><text display-inline="yes-display-inline"/> 
<paragraph id="HBFF65CCAE3CC4BAB8B6F4FD0BB421095"><enum>(1)</enum><header>Initial programs and materials</header><text display-inline="yes-display-inline">Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services (referred to in this subsection as the <quote>Secretary</quote>), in consultation with appropriate experts, shall identify the following model programs and materials (or if no such programs or materials exist, recognize private or public entities to develop and disseminate such programs and materials):</text> 
<subparagraph id="HB038C0BE8E454269A36BC6F7750C5054" commented="no"><enum>(A)</enum><text display-inline="yes-display-inline">Model programs and materials for training health care providers (including physicians, emergency medical personnel, psychiatrists, psychologists, counselors, therapists, nurse practitioners, physician assistants, behavioral health facilities and clinics, care managers, and hospitals, including individuals such as general counsels or regulatory compliance staff who are responsible for establishing provider privacy policies) concerning the permitted uses and disclosures, consistent with the standards and regulations governing the privacy and security of substance use disorder patient records promulgated by the Secretary under section 543 of the Public Health Service Act (42 U.S.C. 290dd–2), as amended by this section, for the confidentiality of patient records.</text></subparagraph> 
<subparagraph id="H28F67DA90AE948C695ABE328CB7EE9DA" commented="no"><enum>(B)</enum><text display-inline="yes-display-inline">Model programs and materials for training patients and their families regarding their rights to protect and obtain information under the standards and regulations described in subparagraph (A).</text></subparagraph></paragraph> 
<paragraph id="HD973E9C304094EF68E7227F76DEA9566"><enum>(2)</enum><header>Requirements</header><text display-inline="yes-display-inline">The model programs and materials described in subparagraphs (A) and (B) of paragraph (1) shall address circumstances under which disclosure of substance use disorder patient records is needed to—</text> 
<subparagraph id="H335DE92B44304130A4C18869CED01B49"><enum>(A)</enum><text display-inline="yes-display-inline">facilitate communication between substance use disorder treatment providers and other health care providers to promote and provide the best possible integrated care;</text></subparagraph> 
<subparagraph id="HF43303C350364BE28E8660CF74591687"><enum>(B)</enum><text display-inline="yes-display-inline">avoid inappropriate prescribing that can lead to dangerous drug interactions, overdose, or relapse; and</text></subparagraph> 
<subparagraph id="HA33ADB2157F8448A8F995686E7027C20"><enum>(C)</enum><text display-inline="yes-display-inline">notify and involve families and caregivers when individuals experience an overdose.</text></subparagraph></paragraph> 
<paragraph id="H4FEB1BE8EF5949289AC18369A33DE4F4"><enum>(3)</enum><header>Periodic updates</header><text>The Secretary shall—</text> 
<subparagraph id="HBE6B9289006F4864A43DD04908E12851"><enum>(A)</enum><text display-inline="yes-display-inline">periodically review and update the model programs and materials identified or developed under paragraph (1); and</text></subparagraph> 
<subparagraph id="HDDB21AD3EF79421694241414403535F1"><enum>(B)</enum><text display-inline="yes-display-inline">disseminate such updated programs and materials to the individuals described in paragraph (1)(A).</text></subparagraph></paragraph> 
<paragraph id="HAB175F08576F4778AA8CA430376AE6C3"><enum>(4)</enum><header>Input of certain entities</header><text display-inline="yes-display-inline">In identifying, reviewing, or updating the model programs and materials under this subsection, the Secretary shall solicit the input of relevant stakeholders.</text></paragraph></subsection> 
<subsection id="HEC4525FC8C4748C38BE233FA3483BDE6"><enum>(l)</enum><header>Rules of construction</header><text display-inline="yes-display-inline">Nothing in this Act or the amendments made by this Act shall be construed to limit—</text> 
<paragraph id="H6609053358A24DB69A1619C6F97EAC18"><enum>(1)</enum><text display-inline="yes-display-inline">a patient’s right, as described in section 164.522 of title 45, Code of Federal Regulations, or any successor regulation, to request a restriction on the use or disclosure of a record referred to in section 543(a) of the Public Health Service Act (42 U.S.C. 290dd–2(a)) for purposes of treatment, payment, or health care operations; or</text></paragraph> 
<paragraph id="HC1B446D4D19B4333A49989F02A316E2D"><enum>(2)</enum><text>a covered entity’s choice, as described in section 164.506 of title 45, Code of Federal Regulations, or any successor regulation, to obtain the consent of the individual to use or disclose a record referred to in such section 543(a) to carry out treatment, payment, or health care operation.</text></paragraph></subsection> 
<subsection id="H346AC7C471CE4ACB8450A99BB7333EBB"><enum>(m)</enum><header>Sense of Congress</header><text display-inline="yes-display-inline">It is the sense of the Congress that—</text> 
<paragraph id="HCDAB7E04BF6442AB88B7DD7CBB3B5F38"><enum>(1)</enum><text>patients have the right to request a restriction on the use or disclosure of a record referred to in section 543(a) of the Public Health Service Act (42 U.S.C. 290dd–2(a)) for treatment, payment, or health care operations; and</text></paragraph> 
<paragraph id="H8AD34E8808FA419C835F67AA42A2037C"><enum>(2)</enum><text>covered entities should make every reasonable effort to the extent feasible to comply with a patient’s request for a restriction regarding such use or disclosure.</text></paragraph></subsection></section> 
</amendment-block></amendment> </amendment-body></amendment-doc>
