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<dc:title>117 S1123 IS: Preserving Innovation for the Next Generation Act</dc:title>
<dc:publisher>U.S. Senate</dc:publisher>
<dc:date>2021-04-14</dc:date>
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<dc:language>EN</dc:language>
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<distribution-code display="yes">II</distribution-code><congress>117th CONGRESS</congress><session>1st Session</session><legis-num>S. 1123</legis-num><current-chamber>IN THE SENATE OF THE UNITED STATES</current-chamber><action><action-date date="20210414">April 14, 2021</action-date><action-desc><sponsor name-id="S396">Mrs. Blackburn</sponsor> introduced the following bill; which was read twice and referred to the <committee-name committee-id="SSFI00">Committee on Finance</committee-name></action-desc></action><legis-type>A BILL</legis-type><official-title>To preserve non-interference under the Medicare part D Prescription Drug Benefit program.</official-title></form><legis-body><section id="S1" 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><short-title>Preserving Innovation for the Next Generation Act</short-title></quote> or the <quote><short-title>PING Act</short-title></quote>.</text></section><section id="idDD4F1E8D7A9A4D559F28BCA63C92AB5E"><enum>2.</enum><header>Findings</header><text display-inline="no-display-inline">Congress makes the following findings:</text><paragraph id="id442c0203df3f4adcbe86abc5e0c40ae6"><enum>(1)</enum><text>Since implementation, the Medicare Prescription Drug Benefit program under part D of title XVIII of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-101">42 U.S.C. 1395w–101</external-xref> et seq.) (referred to in this section as <term>Medicare part D</term>) has succeeded beyond expectations in providing affordable prescription drug coverage for more than 45,000,000 seniors and disabled individuals.</text></paragraph><paragraph id="idfc554095d32d44e08de6987fde18005a"><enum>(2)</enum><text>The competitive market has kept total Medicare part D costs below original estimates, while still offering beneficiaries steady premiums and a variety of alternative formularies and benefit design.</text></paragraph><paragraph id="id864307faf33a4d7b966e11a0c361600d"><enum>(3)</enum><text>This competitive pricing structure works, in large part, due to the <quote>non-interference clause</quote> under Medicare part D which provides for robust private market negotiation without undue government interference.</text></paragraph><paragraph id="id0309c9c946ba41ab976c40a37b23684d"><enum>(4)</enum><text>The Congressional Budget Office repeatedly has said that government negotiation would have a negligible impact on Medicare part D spending unless the government also restricted access to medications.</text></paragraph><paragraph id="id0436548b33694341bdc22c3f1e81488d"><enum>(5)</enum><text>To achieve any significant savings, the government would need to impose access or coverage restrictions on medications. In fact, limiting options will likely result in costs shifting to higher spending for other Medicare services and negatively impact the health of seniors without helping to reduce government spending.</text></paragraph><paragraph id="id8cf6a4014b3d45998ac0e99d976f1238"><enum>(6)</enum><text>Having a broad range of treatment options is fundamental to providing good care to all patients, but particularly so for the Medicare population, who are more likely to be affected by multiple chronic conditions. With the advent of personalized medicines and targeted therapies—where the underlying molecular drivers of disease help identify and direct precise, targeted treatment choices—limiting access reduces the vast potential of breakthrough science to revolutionize care. Therefore, it is imperative to ensure beneficiaries have access to a broader range of medicines to best meet their health needs.</text></paragraph><paragraph id="id45a554b9a4e747efb26e786f89bb7784"><enum>(7)</enum><text>Medicare beneficiaries would not be better off if Medicare part D drug coverage were administered by the Federal Government in the same way as the Veterans Administration. Many veterans rely on other sources to supplement their Veterans Administration drug coverage due to restrictions that limit their access to needed medications. More than half of all veterans supplement their Veterans Administration benefits with other sources of drug coverage, including Medicare part D. A recent Veterans Administration survey shows that approximately 80.4 percent of veterans had both Veterans Administration and non-Veterans Administration health coverage and, among those in Medicare, 33.2 percent have Medicare part D for prescription drug coverage.</text></paragraph><paragraph id="id4ffb5fbc63154a6cab9da22d386c2f81"><enum>(8)</enum><text>Imposing a restrictive Veterans Administration-type formulary on Medicare part D is unlikely to work for the diverse group of more than 45,000,000 beneficiaries enrolled in Medicare part D. Evidence show that seniors would have limited choices and fewer medicines available to them. A recent analysis by Xcenda found that of the top 200 part D brand name drugs, 74 percent or more were covered across stand-alone prescription drug plans and Medicare Advantage prescription drug plans, compared with 52 percent that could be covered by the Veterans Administration formulary.</text></paragraph><paragraph id="id64b7c65708774ef285c3bf32545131c9"><enum>(9)</enum><text>A national formulary would restrict access to affordable and vital prescriptions many Medicare beneficiaries rely on. Robust patient access to a full range of medicines has been a cornerstone of Medicare part D. Restricting access to medicines can significantly reduce adherence. Poorer medication adherence, in turn, can lead to worse health outcomes and higher overall spending.</text></paragraph><paragraph id="idd2f195647a6a4bd7b3ebe03adb5290d6"><enum>(10)</enum><text>Price controls or large penalties to force companies to comply with so-called <quote>negotiations</quote> have resulted in restricted access abroad and threaten similar restrictions on access in the United States. Research demonstrates that government price setting reduces access for patients and results in fewer or delayed treatment options—nearly 90 percent of new medicines launched globally in the past decade are currently available to patients in the United States, only about half are available to patients in other countries like France and Canada.</text></paragraph><paragraph id="idbbad56133d7e4c0ba4aacdecaa31c2ba"><enum>(11)</enum><text>Limiting patient access to medicines contradicts the foundational principles of Medicare part D and the value beneficiaries derive from the program—a recent survey shows that more than 90 percent of Medicare beneficiaries are satisfied with their drug coverage and more than 80 percent said it is important to them to have a variety of prescription drug plans under Medicare part D from which to choose. </text></paragraph></section><section id="id63FA5892FEF340F3AA70E4F0F0A37DEA"><enum>3.</enum><header>Sense of the Senate</header><text display-inline="no-display-inline">It is the sense of the Senate that non-interference in the Medicare part D Prescription Drug Benefit program under section 1860D–11(i) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-111">42 U.S.C. 1395w–111(i)</external-xref>) should not be repealed. </text></section><section id="id2ED7B4FC98F94B808E1D28C8199EDADC"><enum>4.</enum><header>Prohibition on CMI testing of models that would repeal noninterference</header><text display-inline="no-display-inline">Section 1115A(b) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1315a">42 U.S.C. 1315a(b)</external-xref>) is amended by adding at the end the following new paragraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="idC2A6F3836FDA477A8011158FC7927D6C"><paragraph id="idA9959562F2B7495493D6AE3F0C9E4DB5"><enum>(5)</enum><header>Prohibition on testing of models that would repeal noninterference</header><text display-inline="yes-display-inline">The CMI shall not test any model that would repeal or require a waiver of section 1860D–11(i).</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></section></legis-body></bill> 

