II 114th CONGRESS 1st Session S. 2409 IN THE SENATE OF THE UNITED STATES December 16, 2015 Mr. Wyden introduced the following bill; which was read twice and referred to the Committee on Finance A BILL To amend titles XVIII and XIX of the Social Security Act to improve payments for hospital outpatient department services and complex rehabilitation technology and to improve program integrity, and for other purposes.

1. Short title; table of contents (a) Short title This Act may be cited as the Medicare and Medicaid Improvements and Adjustments Act of 2015 . (b) Table of contents The table of contents of this Act is as follows: Sec. 1. Short title; table of contents. Title I—Corrections to Outpatient Provision Sec. 101. Continuing Medicare payment under HOPD prospective payment system for services furnished by off-campus outpatient departments of providers under development. Sec. 102. Maintaining cancer hospital adjustment under Medicare off-campus outpatient departments of a provider payment policy. Title II—Provisions Protecting People with Disabilities and Chronic Care Needs Sec. 201. Non-application of Medicare fee schedule adjustments for wheelchair accessories and seat and back cushions when furnished in connection with complex rehabilitative power wheelchairs. Sec. 202. Treatment of infusion drugs furnished through durable medical equipment. Sec. 203. Transitional payment rules for certain radiation therapy services under the Medicare physician fee schedule. Sec. 204. Fairness in Medicaid supplemental needs trusts. Title III—Program Integrity, Payment Efficiency, and Additional Medicare Policies Sec. 301. Strengthening penalties for the illegal distribution of a Medicare, Medicaid, or CHIP beneficiary identification or billing privileges. Sec. 302. Civil monetary penalties for violations related to grants, contracts, and other agreements. Sec. 303. Authorizing a blanket meaningful use significant hardship exception. Sec. 304. Limiting Federal Medicaid reimbursement to States for durable medical equipment (DME) to Medicare payment rates. Sec. 305. Treatment of patient encounters in ambulatory surgical centers in determining meaningful EHR use. I Corrections to Outpatient Provision 101. Continuing Medicare payment under HOPD prospective payment system for services furnished by off-campus outpatient departments of providers under development Section 1833(t) of the Social Security Act ( 42 U.S.C. 1395l(t) ) is amended— (1) in paragraph (1)(B)(v), by inserting , subject to subparagraph (E) of such paragraph, after 2017, by ; and (2) in paragraph (21)— (A) in subparagraph (C) by striking that are described in paragraph (1)(B)(v) shall be made and inserting to which paragraph (1)(B)(v) applies shall be the amount determined ; (B) by redesignating subparagraph (E) as subparagraph (F); and (C) by inserting after subparagraph (D) the following new subparagraph: (E) Non-application with respect to departments under development (i) In general Paragraph (1)(B)(v) shall not apply to an off-campus outpatient department of a provider that is determined by the Secretary to be under development as of the date of the enactment of the Bipartisan Budget Act of 2015. (ii) Application For purposes of paragraph (1)(B)(v) and this paragraph, in determining whether an off-campus outpatient department of a provider was under development, the Secretary shall require that as of the date of the enactment of such Act the department met— (I) at least one of the requirements described in clause (iii); and (II) any additional requirements the Secretary determines would indicate whether such off-campus outpatient department of a provider was under development as of such date. (iii) Requirements described The following requirements are described in this clause: (I) Architectural plans were completed. (II) Zoning requirements were met or a request for approval of meeting such zoning requirements was submitted to appropriate agencies. (III) Necessary approvals from appropriate State agencies were applied for or received. . 102. Maintaining cancer hospital adjustment under Medicare off-campus outpatient departments of a provider payment policy Section 1833(t) of the Social Security Act ( 42 U.S.C. 1395l(t) ) is amended— (1) in paragraph (1)(B)(v), as amended by section 101(1), by striking subparagraph (E) and inserting subparagraph (F) ; and (2) in paragraph (21), as added by section 603 of the Bipartisan Budget Act of 2015 and as amended by section 101(2)— (A) by redesignating subparagraphs (D), (E), and (F) as subparagraphs (E), (F), and (G), respectively; (B) by inserting after subparagraph (C) the following new subparagraph: (D) Application of cancer hospital adjustment The Secretary shall apply the adjustment under paragraph (18) to applicable items and services furnished on or after January 1, 2017, by an off-campus outpatient department of a provider (as defined in subparagraph (B)) of a hospital described in section 1886(d)(1)(B)(v)— (i) as if this paragraph (other than this subparagraph) and paragraph (1)(B)(v) were not applicable to such applicable items and services and such applicable items and services were covered OPD services and paid under this subsection; and (ii) without application of paragraphs (2)(E) and (9)(B). ; and (C) in subparagraph (G)(iii), as redesignated by subparagraph (A) of this paragraph, by striking subparagraph (D) and inserting subparagraph (E) . II Provisions Protecting People with Disabilities and Chronic Care Needs 201. Non-application of Medicare fee schedule adjustments for wheelchair accessories and seat and back cushions when furnished in connection with complex rehabilitative power wheelchairs (a) Non-Application (1) In general Notwithstanding any other provision of law, the Secretary of Health and Human Services shall not, prior to January 1, 2017, use information on the payment determined under the competitive acquisition programs under section 1847 of the Social Security Act ( 42 U.S.C. 1395w–3 )) to adjust the payment amount that would otherwise be recognized under section 1834(a)(1)(B)(ii) of such Act ( 42 U.S.C. 1395m(a)(1)(B)(ii) ) for wheelchair accessories (including seating systems) and seat and back cushions when furnished in connection with Group 3 complex rehabilitative power wheelchairs. (2) Implementation Notwithstanding any other provision of law, the Secretary may implement this subsection by program instruction or otherwise. (b) GAO study and report (1) Study (A) In general The Comptroller General of the United States shall conduct a study on wheelchair accessories (including seating systems) and seat and back cushions furnished in connection with Group 3 complex rehabilitative power wheelchairs. Such study shall include an analysis of the following with respect to such wheelchair accessories and seat and back cushions in each of the groups described in clauses (i) through (iii) of subparagraph (B): (i) The item descriptions and associated HCPCS codes for such wheelchair accessories and seat and back cushions. (ii) A breakdown of utilization and expenditures for such wheelchair accessories and seat and back cushions under title XVIII of the Social Security Act. (iii) A comparison of the payment amount under the competitive acquisition program under section 1847 of such Act ( 42 U.S.C. 1395w–3 ) with the payment amount that would otherwise be recognized under section 1834 of such Act ( 42 U.S.C. 1395m ), including beneficiary cost sharing, for such wheelchair accessories and seat and back cushions. (iv) The aggregate distribution of such wheelchair accessories and seat and back cushions furnished under such title XVIII within each of the groups described in subparagraph (B). (v) Other areas determined appropriate by the Comptroller General. (B) Groups described The following groups are described in this subparagraph: (i) Wheelchair accessories and seat and back cushions furnished predominantly with Group 3 complex rehabilitative power wheelchairs. (ii) Wheelchair accessories and seat and back cushions furnished predominantly with power wheelchairs that are not described in clause (i). (iii) Other wheelchair accessories and seat and back cushions furnished with either power wheelchairs described in clause (i) or (ii). (2) Report Not later than June 1, 2016, the Comptroller General of the United States shall submit to Congress a report containing the results of the study conducted under paragraph (1), together with recommendations for such legislation and administrative actions as the Comptroller General determines to be appropriate. 202. Treatment of infusion drugs furnished through durable medical equipment Section 1842(o)(1) of the Social Security Act ( 42 U.S.C. 1395u(o)(1) ) is amended— (1) in subparagraph (C), by inserting (and including a drug or biological described in subparagraph (D)(i) furnished during the 6-year period beginning on January 1, 2017) after 2005 ; and (2) in subparagraph (D)— (A) by striking infusion drugs and inserting infusion drugs or biologicals each place it appears; and (B) in clause (i)— (i) by striking 2004 and inserting 2004 (other than during the 6-year period beginning on January 1, 2017) ; and (ii) by striking for such drug . 203. Transitional payment rules for certain radiation therapy services under the Medicare physician fee schedule (a) In general Section 1848 of the Social Security Act ( 42 U.S.C. 1395w–4 ) is amended— (1) in subsection (b), as amended by section 502 of division O of the Consolidated Appropriations Act, 2016, by adding at the end the following new paragraph: (11) Special rule for certain radiation therapy services The code definitions, the work relative value units under subsection (c)(2)(C)(i), and the direct inputs for the practice expense relative value units under subsection (c)(2)(C)(ii) for radiation treatment delivery and related imaging services (identified in 2016 by HCPCS G-codes G6001 through G6015) for the fee schedule established under this subsection for services furnished in 2017 and 2018 shall be the same as such definitions, units, and inputs for such services for the fee schedule established for services furnished in 2016. ; and (2) in subsection (c)(2)(K), by adding at the end the following new clause: (iv) Treatment of certain radiation therapy services Radiation treatment delivery and related imaging services identified under subsection (b)(11) shall not be considered as potentially misvalued services for purposes of this subparagraph and subparagraph (O) for 2017 and 2018. . (b) Report to Congress on alternative payment model Not later than 18 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit to Congress a report on the development of an episodic alternative payment model for payment under the Medicare program under title XVIII of the Social Security Act for radiation therapy services furnished in nonfacility settings. 204. Fairness in Medicaid supplemental needs trusts (a) In general Section 1917(d)(4)(A) of the Social Security Act ( 42 U.S.C. 1396p(d)(4)(A) ) is amended by inserting the individual, after for the benefit of such individual by . (b) Effective date The amendment made by subsection (a) shall apply to trusts established on or after the date of the enactment of this Act. III Program Integrity, Payment Efficiency, and Additional Medicare Policies 301. Strengthening penalties for the illegal distribution of a Medicare, Medicaid, or CHIP beneficiary identification or billing privileges Section 1128B(b) of the Social Security Act (42 U.S.C. 1320a–7b(b)) is amended by adding at the end the following: (4) Whoever without lawful authority knowingly and willfully purchases, sells or distributes, or arranges for the purchase, sale, or distribution of a beneficiary identification number or unique health identifier for a health care provider under title XVIII, title XIX, or title XXI shall be imprisoned for not more than 10 years or fined not more than $500,000 ($1,000,000 in the case of a corporation), or both. . 302. Civil monetary penalties for violations related to grants, contracts, and other agreements (a) In general Section 1128A of the Social Security Act ( 42 U.S.C. 1320a–7a ) is amended by adding at the end the following new subsection: (o) Any person (including an organization, agency, or other entity, but excluding a program beneficiary, as defined in subsection (r)(4)) that, with respect to a grant, contract, or other agreement for which the Secretary of Health and Human Services provides funding— (1) knowingly presents or causes to be presented a specified claim (as defined in subsection (r)(6)) under such grant, contract, or other agreement that the person knows or should know is false or fraudulent; (2) knowingly makes, uses, or causes to be made or used any false statement, omission, or misrepresentation of a material fact in any application, proposal, bid, progress report, or other document that is required to be submitted in order to directly or indirectly receive or retain funds provided in whole or in part by such Secretary pursuant to such grant, contract, or other agreement; (3) knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent specified claim under such grant, contract, or other agreement; (4) knowingly makes, uses, or causes to be made or used, a false record or statement material to an obligation to pay or transmit funds or property to such Secretary with respect to such grant, contract, or other agreement, or knowingly conceals or knowingly and improperly avoids or decreases an obligation to pay or transmit funds or property to such Secretary with respect to such grant, contract, or other agreement; or (5) fails to grant timely access, upon reasonable request (as defined by such Secretary in regulations), to the Inspector General of the Department, for the purpose of audits, investigations, evaluations, or other statutory functions of such Inspector General in matters involving such grants, contracts, or other agreements, shall be subject, in addition to any other penalties that may be prescribed by law, to a civil money penalty in cases under paragraph (1), of not more than $10,000 for each specified claim; in cases under paragraph (2), not more than $50,000 for each false statement, omission, or misrepresentation of a material fact; in cases under paragraph (3), not more than $50,000 for each false record or statement; in cases under paragraph (4), not more than $50,000 for each false record or statement or $10,000 for each day that the person knowingly conceals or knowingly and improperly avoids or decreases an obligation to pay; or in cases under paragraph (5), not more than $15,000 for each day of the failure described in such paragraph. In addition, in cases under paragraphs (1) and (3), such a person shall be subject to an assessment of not more than 3 times the amount claimed in the specified claim described in such paragraph in lieu of damages sustained by the United States or a specified State agency because of such specified claim, and in cases under paragraphs (2) and (4), such a person shall be subject to an assessment of not more than 3 times the total amount of the funds described in paragraph (2) or (4), respectively (or, in the case of an obligation to transmit property to the Secretary Health and Human Services described in paragraph (4), of the value of the property described in such paragraph) in lieu of damages sustained by the United States or a specified State agency because of such case. In addition, the Secretary of Health and Human Services may make a determination in the same proceeding to exclude the person from participation in the Federal health care programs (as defined in section 1128B(f)(1)) and to direct the appropriate State agency to exclude the person from participation in any State health care program. (p) The provisions of subsections (c), (d), and (g) shall apply to a civil money penalty or assessment under subsection (o) in the same manner as such provisions apply to a penalty, assessment, or proceeding under subsection (a). (q) With respect to a penalty or assessment under subsection (o), the Inspector General of the Department is authorized to receive, and to retain for current use, such amounts of such penalty or assessment as are necessary to provide reimbursement for the costs of conducting investigations and audits with respect to such subsection and for monitoring compliance plans with respect to such subsection when such penalty or assessment is ordered by a court, voluntarily agreed to by the payor, or otherwise. Funds received by such Inspector General as reimbursement under the preceding sentence shall be deposited to the credit of the appropriations from which initially paid, or to appropriations for similar purposes currently available at the time of deposit, and shall remain available for obligation for 1 year from the date of the deposit of such funds. (r) For purposes of this subsection and subsections (o), (p), and (q): (1) The term Department means the Department of Health and Human Services. (2) The term material means having a natural tendency to influence, or be capable of influencing, the payment or receipt of money or property. (3) The term other agreement includes a cooperative agreement, scholarship, fellowship, loan, subsidy, payment for a specified use, donation agreement, award, or sub-award (regardless of whether one or more of the persons entering into the agreement is a contractor or sub-contractor). (4) The term program beneficiary means, in the case of a grant, contract, or other agreement designed to accomplish the objective of awarding or otherwise furnishing benefits or assistance to individuals and for which the Secretary of Health and Human Services provides funding, an individual who applies for, or who receives, such benefits or assistance from such grant, contract, or other agreement. Such term does not include, with respect to such grant, contract, or other agreement, an officer, employee, or agent of a person or entity that receives such grant or that enters into such contract or other agreement. (5) The term recipient includes a sub-recipient or subcontractor. (6) The term specified claim means any application, request, or demand under a grant, contract, or other agreement for money or property, whether or not the United States or a specified State agency has title to the money or property, that is not a claim (as defined in subsection (i)(2)) and that— (A) is presented or caused to be presented to an officer, employee, or agent of the Department or agency thereof, or of any specified State agency; or (B) is made to a contractor, grantee, or any other recipient if the money or property is to be spent or used on the Department’s behalf or to advance a Department program or interest, and if the Department— (i) provides or has provided any portion of the money or property requested or demanded; or (ii) will reimburse such contractor, grantee or other recipient for any portion of the money or property which is requested or demanded. (7) The term specified State agency means an agency of a State government established or designated to administer or supervise the administration of a grant, contract, or other agreement funded in whole or in part by the Secretary of Health and Human Services. (s) For purposes of subsection (o), the term obligation means an established duty, whether or not fixed, arising from an express or implied contractual, grantor-grantee, or licensor-licensee relationship, for a fee-based or similar relationship, from statute or regulation, or from the retention of any overpayment. . (b) Conforming amendments Section 1128A of the Social Security Act ( 42 U.S.C. 1320a–7a ) is amended— (1) in subsection (d)— (A) in paragraph (1), by inserting or specified claims after claims ; and (B) in paragraph (2), by inserting or specified claims after claims ; (2) in subsection (e), by inserting or specified claim after claim ; and (3) in subsection (f)— (A) by inserting or specified claim (as defined in subsection (r)(6)) after district where the claim ; (B) by inserting (or, with respect to a person described in subsection (o), the person) after claimant ; (C) by inserting that are not received by the Inspector General of the Department of Health and Human Services under subsection (q) as reimbursement after amounts recovered ; and (D) by inserting (or, in the case of a penalty or assessment under subsection (o), by a specified State agency (as defined in subsection (r)(7)) after or a State agency . 303. Authorizing a blanket meaningful use significant hardship exception (a) Physicians’ services Section 1848(a)(7)(B) of the Social Security Act ( 42 U.S.C. 1395w–4(a)(7)(B) ) is amended by inserting (or through a blanket exception with respect to the payment adjustment for 2017, but only if a request for such exception is filed no later than June 30, 2016) after on a case-by-case basis . (b) Hospital services Section 1886(b)(3)(B)(ix)(II) of the Social Security Act ( 42 U.S.C. 1395ww(b)(3)(B)(ix)(II) ) is amended by inserting (or through a blanket exception with respect to the payment adjustment for fiscal year 2017, but only if a request for such exception is filed no later than June 30, 2016) after on a case-by-case basis . (c) Implementation authority The Secretary of Health and Human Services may implement the amendments made by this section by interim final rule with comment period. 304. Limiting Federal Medicaid reimbursement to States for durable medical equipment (DME) to Medicare payment rates Section 1903(i)(27) of the Social Security Act ( 42 U.S.C. 1396b(i)(27) ), as added by section 503(a)(1) of division O of the Consolidated Appropriations Act, 2016, is amended by striking January 1, 2019 and inserting October 1, 2018 . 305. Treatment of patient encounters in ambulatory surgical centers in determining meaningful EHR use Section 1848(o)(2) of the Social Security Act ( 42 U.S.C. 1395w–4(o)(2) ) is amended by adding at the end the following new subparagraph: (E) Treatment of patient encounters at ambulatory surgical centers (i) In general Subject to clause (ii), with respect to a payment adjustment applied under subsection (a)(7)(A), for 2017 or a subsequent year, any patient encounter of an eligible professional occurring at an ambulatory surgical center (described in section 1833(i)(1)(A)) shall not be treated as a patient encounter in determining whether an eligible professional qualifies as a meaningful EHR user. Notwithstanding any other provision of law, the Secretary may implement this clause by program instruction or otherwise. (ii) Sunset Clause (i) shall no longer apply as of the first payment year that begins more than 3 years after the date the Secretary determines, through notice and comment rulemaking, that certified EHR technology is applicable to the ambulatory surgical center setting. .