Title: Stark Administrative Simplification Act of 2018
Policy area: Health

Summary:
Stark Administrative Simplification Act of 2018
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 & Medicaid Services, or (3) documentation of the arrangement contains specified identifying information but is otherwise insufficient to satisfy the writing requirement of an applicable exception.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 3054 Introduced in Senate (IS)]

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115th CONGRESS
  2d Session
                                S. 3054

 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.


_______________________________________________________________________


                   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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Stark Administrative Simplification 
Act of 2018''.

SEC. 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.''.
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