CMS-6061-ANPRM

DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 411 [CMS-6061-ANPRM] RIN 0938-AR88 Medicare Program; Medicare Secondary Payer and Certain Civil Money Penalties AGENCY: Centers for Medicare & Medi caid Services (CMS), HHS. ACTION: Advance notice of proposed rulemaking. SUMMARY: This advance notice of proposed rulemaking (ANPRM) solicits public comment on specific practices for which civ il money penalties (CMPs) may or may not be imposed for failure to comply with Me dicare Secondary Payer reporting requirements for certain group health and non-gro up health plans arrangements. DATES: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on [ OFR--insert date 60 da ys after date of publication in the Federal Register]

. ADDRESSES: In commenting, please refer to file code CMS-6061-ANPRM. Because of staff and resource lim itations, we cannot accept co mments by facsimile (FAX) transmission. You may submit comments in one of four ways (please choose only one of the ways listed) 1. Electronically. You may submit elec tronic comments on this regulation to http://www.regulations.gov . Follow the instructions under the "More Search Options" tab. 2. By regular mail. You may mail writt en comments to the following addressCMS-6061-ANPRM

ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-6061-ANPRM, P.O. Box 8013, Baltimore, MD 21244-8013. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. By express or overnight mail . You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-6061-ANPRM, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. 4. By hand or courier . If you prefer, you may deliver (by hand or courier) your written comments before the close of the comment period to either of the following addresses: a. For delivery in Washington, D.C.-- Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW,CMS-6061-ANPRM Washington, D.C. 20201. (Because access to the interior of the Hube rt H. Humphrey Building is not readily available to persons without Federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available fo r persons wishing to re tain a proof of filing by stamping in and retaining an extra copy of the comments being filed.) b. For delivery in Baltimore, MD-- Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850. If you intend to deliver your comments to the Baltimore address, please call telephone number (410) 786-9994 in advance to schedul e your arrival with one of our staff members. Comments mailed to the addresses indicat ed as appropriate for hand or courier delivery may be delayed and rece ived after the comment period. For information on viewing public co mments, see the beginning of the “SUPPLEMENTARY INFORMATION” section. FOR FURTHER INFORMATION CONTACT: Suzanne Mattes, (410) 786-2536. SUPPLEMENTARY INFORMATION: Inspection of Public Comments : All comments received before the close of the comment period are available for viewi ng by the public, including any personally identifiable or confidential business informa tion that is included in a comment. We postCMS-6061-ANPRM

all comments received before the close of the comment period on the following Web site as soon as possible after th ey have been received: http://www.regulations.gov/

. Comments received timely will be also available for pub lic inspection as they are received, generally beginning approximately 3 weeks after publicati on of a document, at the headquarters of the Centers for Medicare & Medicaid Serv ices, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view pub lic comments, please phone 1-800-743-3951. I. Background A. Imposition of Civil Money Penalties (CMPs) In 1981, the Congress added s ection 1128A to the Social Security Act (the Act) (section 2105 of Pub. L. 97-35) to authorize the Secretary of Health and Human Services (Secretary) to impose civil money penalties (CMPs) and assessments on certain health care facilities, health care practitioners, and other supplie rs for noncompliance with rules of the Medicare and Medicaid programs. CMPs and assessmen ts provide an alternative enforcement tool for agencies use to ensu re compliance with statutory and regulatory requirements and are in addition to pote ntial criminal or civil penalties. Since 1981, the Congress has significantly increased both the number and the types of circumstances under which the Secretary may impose CMPs. Some CMP authorities address fraud, mi srepresentation, or falsific ation, while others address noncompliance with programmatic or regul atory requirements. The Secretary has delegated the authority for certain provisions to either the Office of Inspector General (OIG) or CMS (See the October 20, 1994 (58 FR 52967) notice titled “Office of Inspector General; Health Care Financing Administration; Statement of Organization, Functions, and Delegations of Authority”).CMS-6061-ANPRM

B. Section 111 of the MMSEA Amendments to MSP Provisions Under the Medicare law, as enacted in 1965, Medicare was the primary payer for certain designated health care services excep t those covered by workers' compensation. In 1980, Congress added section 1862(b) of the Act which defined when Medicare is the secondary payer to certain primary plans. These provisions are known as the Medicare Secondary Payer (MSP) provision s. Section 1862(b) of the Act prohibits Medicare from making payment if payment has been made or can reasonably be expected to be made by the following primary plans when certain c onditions are satisfied: group health plans; workers’ compensation plans; liability insura nce (including self-ins urance); or no-fault insurance For workers’ compensation, liability insurance (including self-insurance), or no-fault insurance for which payment has not been made or cannot be expected to be made promptly, Medicare may make a condi tional payment subject to Medicare payment rules. Any conditional payments made by Me dicare are subject to repayment once the primary plan makes payment. Section 111 of the Medicare, Medica id, and SCHIP Extension Act of 2007 (MMSEA) (Pub. L. 110-173) added paragraphs (7 ) and (8) to section 1862(b) of the Act which established new mandatory reporting requirements for certain group health plan (GHP) arrangements and for liability insu rance (including self-insurance), no-fault insurance, and workers' compensation (collect ively referred to as “non-GHP” or NGHP) arrangements. Section 1862(b)(7) of the Act (42 U.S.C. 1395y(b)(7)) added new reporting rules for GHP, but did not eliminate any existing statutory provisi ons or regulations. Section 1862(b)(7) of the Act also includes, in pa rt, authority for Medicare to impose CMPs against GHPs responsible reporting entities whic h are determined to be noncompliant.CMS-6061-ANPRM An entity serving as an insurer or third party administrator for a GHP, and, in the case of a GHP that is self-insured and self-administe red, a plan administrator or fiduciary, must report under these requirements. Secti on 1862(b)(7) of the Act provides that, notwithstanding any other pr ovision of law, the reporting requirement may be implemented by program instruction or otherwise. Section 1862(b)(8) of the Act (42 U.S.C. 1395y(b)(8)) added new reporting rules for NGHP arrangements (applicab le plans), but did not elim inate any existing statutory provisions or regulations. Sec tion 1862(b)(8) of the Act also includes, in part, authority for CMS to impose CMPs against NGHPs which are determined to be noncompliant. Section 1862(b)(8) of the Act defines the term “applicable plan” to mean the following laws, plans, or other arrangements, including th e fiduciary or administrator for such law, plan, or arrangement: (1) liability insu rance (including sel f-insurance); (2) no fault-insurance; and (3) workers' compensation laws or plans. Sec tion 1862(b)(8) of the Act also requires applicable plans to notify CMS when they pay liability insurance (including self-insurance), no-fault insurance, and/or workers’ compensation claims on behalf of Medicare beneficiar ies. Information shall be submitted within a time specified by the Secretary after the claim is addresse d or resolved (or partially addressed or resolved) through a set tlement, judgment, award, or other payment, regardless of whether or not there is a determination or admission of liability. C. Medicare IVIG (Intravenous Immunogl obulin) Access and Strengthening Medicare and Repaying Taxpayers Act of 2012 Section 1862(b)(8)(E) of the Act describe s the enforcement provisions for NGHPs that fail to comply with the reporting re quirements. On January 10, 2013, the Medicare IVIG (Intravenous Immunoglobulin) Access and Strengthening Medicare and RepayingCMS-6061-ANPRM Taxpayers Act of 2012 (SMART Act) was enacted (Pub. L. 112-242). The SMART Act amended section 1862(b)(8)(E) of the Act to stat e that applicable plan s that fail to comply with the reporting requirements may be subj ect to a civil money penalty of up to $1,000 for each day of noncompliance with respect to each claimant (revising the prior mandatory nature of this CMPS provision) . Section 1862(b)(8)(E) of the Act only applies to NGHPs. II. Provisions of the Advanced Notice of Proposed Rulemaking We are issuing this ANPRM to solici t public comments and proposals for the specification of practices for which CMPs woul d or would not be imposed in accordance with sections 1862(b)(7)(B) and (b)(8)(E ) of the Act (42 U.S.C. 1395y(b)(7)(B) and(8)(E)). We are interested in comm ents and proposals to specifically define “noncompliance” in the context of the phras e, “...for each day of noncompliance with respect to each claimant...” in sections 1862(b)(7 ) or (b)(8) of the Act. We are seeking public comment and proposals on mechanisms and criteria that we would employ to evaluate whether and when the agency would impose CMPs. In addition, we are we are soliciting comments and proposals for methods to determine the dollar amount of a CMP that w ould be levied for each day that NGHP is a responsible reporting entity noncompliance under section 1862(b)(8) of the Act. We are also soliciting comments on how we might devise a method(s) and criteria to determine which actions would constitute “g ood faith effort(s)” taken by an entity to identify a Medicare beneficiary for the pur poses of reporting unde r section 1862(b)(8) of the Act. We are specifically soliciting comments and proposals from insurers, third party administrators for GHPs, other applicable plans, and the public. When submittingCMS-6061-ANPRM comments regarding this issue, we ask that commenters specifically identify to which provision their comments relate (that is, section 1862(b)(7) or (b)(8) of the Act).CMS-6061-ANPRM Catalog of Federal Domestic Assist ance Program No. 93.773, Medicare--Hospital Insurance; and Program No. 93.774, Medica re--Supplementary Medical Insurance Program)

Dated: May 28, 2013

________________________________ Marilyn Tavenner, Administrator, Centers for Medicare & Medicaid Services.

Approved: July 30, 2013

___________________________________ Kathleen Sebelius, Secretary, Department of Health and Human Services. BILLING CODE 4120-01-PCMS-6061-ANPRM

[FR Doc. 2013-29473 Filed 12/10/2013 at 8: 45 am; Publication Date: 12/11/2013]