June 16, 2009 | Judith Kares | Comments 2
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Never Events—CMS issues surgical error NCDs and related guidance

In 2002, the National Quality Forum (NQF) published a list of 27 events identified as “serious, largely preventable and of concern to both the public and health care providers.”  These events have become more popularly known as “never events”—events that should never occur in a well-run health care facility with appropriate quality controls.  The updated list currently contains 28 adverse events, including the following surgical errors:

  • Wrong surgical or other invasive procedure performed on a patient;
  • Surgical or other invasive procedure performed on the wrong body part; and
  • Surgical or other invasive procedure performed on the wrong patient.

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Such errors could result in serious injury and/or death to Medicare beneficiaries, as well as significant additional costs to correct adverse outcomes arising from these medical mistakes.

On Friday, June 12, 2009, CMS published two related transmittals:

  • R101NCD, which sets out national coverage determinations (NCDs) for these three adverse events; and
  • R1755CP, which contains related updates to the Medicare Claims Processing Manual.

Under the new NCDs, effective for services performed on and after January 15, 2009, CMS will not cover surgical or other invasive procedures performed in error (e.g., wrong surgery/other invasive procedure, wrong body part, wrong patient), as described above.  In addition, Medicare will also not cover hospitalizations and other procedures “related” to these non-covered services.

For purposes of these NCDs, “related” services include, but are not limited to (1) all services provided in the operating room when an error occurs, even though the services would otherwise be individually billable by those providers present; and (2) all related services provided during the same hospitalization in which the error occurred. Related services, however, do not include performance of the correct procedure, nor do they include reasonable and necessary services performed following discharge from the hospital, even if related to the surgical error.

Hospitals and other providers and practitioners are encouraged to read both of these transmittals carefully.  Key definitions, specific billing and coding instructions, and details regarding the applicability of prior beneficiary notice in the form of ABNs and HINNs are included.

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Judith Kares About the Author: Judith Kares is an instructor for HCPro's Medicare Boot Camp - Hospital Version. Judith has also been involved in the following:

  • Development of comprehensive compliance programs
  • Initial and follow-up risk assessments
  • Development and implementation of compliance training programs
  • Compliance audits and internal investigations
  • Research/advice regarding specific risk areas
  • Development of corrective action programs
Prior to beginning her current legal/consulting practice, Judith spent a number of years in private law practice, representing hospitals and other health care clients, and then as in-house legal counsel. In that capacity, she served first as Assistant General Counsel and Director of the Legal Department for Blue Cross and Blue Shield of Arizona (BCBSAZ) and then as Deputy General Counsel, Regulatory and Contract Compliance, with Blue Cross and Blue Shield of the National Capital Area (BCBSNCA) in Washington, D.C.

In both in-house positions, Judith had primary responsibility for contracting and regulatory compliance. The latter included oversight of federal and state health care programs. BCBSAZ was a fiscal intermediary, a Medicare risk and AHCCCS (Arizona's managed care alternative to traditional Medicaid) contractor, as well as a participating contractor under the national Blue Cross/Blue Shield Federal Employee Program.

Judith is also an adjunct faculty member at the University of Phoenix, where she teaches courses in business and health care law and ethics. She is an advocate for the use of alternatives to traditional dispute resolution, having participated in the volunteer mediation program in the Justice Courts of Maricopa County, Arizona. Judith is a frequent speaker at healthcare-related seminars. In addition to her membership in the State Bar of Arizona and the Tennessee Bar Association, Judith is a member of the American Health Lawyers Association, the Health Care Compliance Association, and the Arizona Association of Health Care Lawyers.

Judith earned her Juris Doctor degree (with high distinction) from The University of Iowa, College of Law and her B.A. (with highest distinction) from Purdue University.

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  1. Judith
    Could you provide a citation to the federal law that authorized CMS to refuse reimbursement of never events and the implementing regulations?

    Thanks

  2. Judith Kares

    Hi Phil

    I don’t have a specific statutory or regulatory cite, but the transmittals cited in the Note (R1755CP and R101NCD) provide background information regarding the identification of the three specific surgical events that have been determined to be “serious, largely preventable, and of concern to both the public and health care providers,” as well as the specific coverage rules that apply to these three events (R1755CP).

    Presumably, CMS’ authority for identifying these three events as non-covered arises under their general authority to determine what services are covered under Medicare. The primary coverage requirement established under Medicare law is that services be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. (See §1862(a)(1)(A) of the Social Security Act). It would be difficult to make the argument that the never events meet this threshold coverage requirement.

    Judith

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