Stark Administrative Simplification Act of 2018

Bill: 115-s-3054
Sponsor: full_name: Sen. Perdue, David [R-GA]
Introduced: 2018-06-12
Policy area: Health
Subjects: Business ethics

Civil actions and liability

Health personnel

Medical ethics

Medicare
Latest action: action_date: 2018-06-12
text: Read twice and referred to the Committee on Finance.

Summaries:
action_date: 2018-06-12
action_desc: Introduced in Senate
text: <p><strong>Stark Administrative Simplification Act of </strong><b>2018</b></p> <p>This bill establishes alternative protocols and sanctions for inadvertent technical noncompliance with the Stark Rule against self-referral under Medicare. "Technical noncompliance" means, with respect to a compensation arrangement, that: (1) the agreement is not signed by one or more parties to the arrangement, (2) the arrangement was a holdover arrangement for a period longer than is allowed by the Centers for Medicare &amp; Medicaid Services, or (3) documentation of the arrangement&nbsp;contains specified identifying information&nbsp;but is otherwise insufficient to satisfy the writing requirement of an applicable exception. </p>

tv_txt: II 115th CONGRESS 2d Session S. 3054 IN THE SENATE OF THE UNITED STATES June 12, 2018 Mr. Perdue introduced the following bill; which was read twice and referred to the Committee on Finance A BILL To amend title XVIII of the Social Security Act to create alternative sanctions for technical noncompliance with the Stark rule under Medicare, and for other purposes.

1. Short title This Act may be cited as the Stark Administrative Simplification Act of 2018 . 2. Alternative sanctions for technical noncompliance with Stark rule under Medicare Section 1877 of the Social Security Act ( 42 U.S.C. 1395nn ) is amended by adding at the end the following new subsection: (j) Self-Disclosure protocols (1) In general Beginning one year after the date of the enactment of this subsection— (A) an entity or individual may voluntarily disclose a compensation arrangement with actual or potential inadvertent technical noncompliance with subsection (a)(1) (as defined in paragraph (3)(H)) pursuant to either the self-referral disclosure protocol (defined in paragraph (2)) or the alternative protocol for technical noncompliance under paragraph (3); (B) disclosures voluntarily withdrawn from the alternative protocol for technical noncompliance may be submitted to the self-referral disclosure protocol; and (C) an entity that, prior to the establishment of the alternative protocol for technical noncompliance, disclosed to the self-referral disclosure protocol a compensation arrangement that was in inadvertent technical noncompliance with subsection (a)(1), may elect, not later than one year after such alternative protocol is established, to withdraw such disclosure from the self-referral disclosure protocol and instead submit the disclosure to such alternative protocol. (2) Self-referral disclosure protocol The term self-referral disclosure protocol or SRDP means the protocol specified in section 6409 of Public Law 111–148 . (3) Alternative protocol for inadvertent technical noncompliance (A) In general The Secretary shall establish, not later than one year after the date of the enactment of this subsection, an alternative protocol for technical noncompliance (in this subsection referred to as the APTN ) to enable entities to disclose arrangements that were previously in inadvertent technical noncompliance with subsection (a)(1) and, upon the Secretary’s acceptance of the disclosure, make payment of a civil monetary penalty. Payment of such civil monetary penalty for an arrangement shall resolve only overpayments due and owing as a result of such arrangement’s inadvertent technical noncompliance with subsection (a)(1). The provisions of section 6409 of Public Law 111–148 shall not apply to this subsection. (B) Disclosure requirements Arrangements disclosed to the APTN must— (i) involve only inadvertent technical noncompliance with subsection (a)(1) that was ended by termination or expiration of the arrangement, or by action of the parties to the arrangement to resolve the technical noncompliance, prior to the date of submission of the disclosure to the APTN; (ii) be made in the form and manner specified by the Secretary on the public Internet website of the Centers for Medicare & Medicaid Services and include descriptions of— (I) the compensation arrangement that was in technical noncompliance with subsection (a)(1); (II) how and when the technical noncompliance with subsection (a)(1) was ended or the arrangement was otherwise terminated; and (III) how the remuneration paid under the compensation arrangement being disclosed was— (aa) consistent with the fair market value of the items and services that were provided under the compensation arrangement; and (bb) not determined in a manner that directly or indirectly takes into account the volume or value of referrals or other business generated between the parties; (iii) include a form settlement agreement provided by the Secretary signed by the entity; and (iv) include a certification from the entity that, to the best of the entity’s knowledge, the information provided is truthful information and is based on a good faith effort to bring the matter to the Secretary’s attention. (C) Acceptance or rejection of disclosure by the secretary The following rules shall apply to the acceptance or rejection of a disclosure under the APTN: (i) The Secretary shall accept or reject a complete, accurate, and timely disclosure. (ii) Upon receipt of a disclosure, the Secretary shall notify the disclosing party of such receipt. (iii) The Secretary may request additional information from the disclosing party. (iv) Upon acceptance by the Secretary, the Secretary shall notify the disclosing party in writing of such acceptance. (v) The disclosure shall be rejected if— (I) the disclosing party fails to furnish the additional information requested by the Secretary in such form and manner as the Secretary may specify; or (II) in the Secretary’s sole determination, the noncompliance disclosed did not meet the disclosure requirements specified in subparagraph (B). (vi) The disclosure shall be accepted if— (I) the Secretary has issued a written notice to the disclosing party that the disclosure is determined to satisfy the requirements for disclosures under this section; or (II) the disclosure is complete, accurate, and timely and satisfies each of the requirements for disclosures under this section, 180 calendar days have passed since notification of receipt by the Secretary of the disclosure, and the Secretary has not rejected the disclosure during that period. (vii) In determining whether to accept a disclosure, the Secretary may reasonably rely on the information and certifications included in the disclosure. (D) Rule for withdrawal of disclosure Prior to acceptance or rejection of a disclosure by the Secretary, an entity may voluntarily withdraw such disclosure from the APTN. (E) Civil monetary penalties pursuant to the alternative protocol for technical noncompliance (i) In general Subject to clause (ii), for each arrangement disclosed under this subsection and accepted under subparagraph (C), the Secretary shall impose a single civil monetary penalty of— (I) $5,000, in the case in which disclosure of the inadvertent technical noncompliance with subsection (a)(1) was submitted to the Secretary not later than the date that is one year after the initial date of inadvertent technical noncompliance with subsection (a)(1); or (II) $10,000, in the case in which the disclosure of the inadvertent technically noncompliance with subsection (a)(1) was submitted to the Secretary— (aa) after the date that is more than one year after the initial date of the entity’s inadvertent technical noncompliance with subsection (a)(1); and (bb) not after the date that is 3 years (or, in the case of a disclosure submitted after the 5th year for which this subsection applies, the date that is 2 years) from the initial date of the entity’s inadvertent technical noncompliance with subsection (a)(1). (ii) Special rule for entities that disclosed to the aptn after withdrawing a disclosure from the srdp In the case of an entity that elects under paragraph (1)(C) to withdraw a disclosure from the self-referral disclosure protocol (as defined in paragraph (2)) and instead submit the disclosure to the APTN under this subsection, in determining the applicable civil monetary penalty under clause (i), the date of disclosure to the self-referral disclosure protocol shall be substituted for the date of disclosure to the APTN. (F) Relation to advisory opinions The APTN shall be separate from the advisory opinion process set forth in regulations implementing subsection (g) of this section. (G) Publication on internet website of aptn information Not later than one year after the date of the enactment of this subsection, the Secretary shall post information on the public Internet website of the Centers for Medicare & Medicaid Services to inform relevant stakeholders of how to disclose and make payment of a civil monetary penalty for inadvertent technical noncompliance with subsection (a)(1). (H) Definitions In this subsection: (i) Technical noncompliance The term technical noncompliance with subsection (a)(1) means, with respect to a compensation arrangement, that— (I) the arrangement is not signed by one or more parties to the arrangement; (II) following the expiration of the arrangement, the arrangement was a holdover arrangement for a period longer than permitted in regulations issued by the Secretary; or (III) the contemporaneous written documentation evidencing the terms of the arrangement identifies the parties to the arrangement and the items, services, space, or equipment, as applicable, but is not sufficient to satisfy the writing requirement of an applicable exception. (ii) Inadvertent The term inadvertent means, with respect to a compensation arrangement that is in technical noncompliance with subsection (a)(1), that an entity that is a party to the compensation arrangement did not know or should not have known of the noncompliance. (I) Administration Chapter 35 of title 44, United States Code, shall not apply to this subsection. (J) Implementation Notwithstanding any other provision of law, the Secretary may implement the provisions of this paragraph by program instruction or otherwise. .