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    April 25, 2016

    Acting Administrator Andrew Slavitt, MBA
    Centers for Medicare & Medicaid Services
    Department of Health and Human Services
    Attention: CMS-6058-P
    P.O. Box 8013
    Baltimore, Maryland 21244-8013

    Dear Acting Administrator Slavitt:

    The Medical Group Management Association (MGMA) appreciates the opportunity to submit the following comments in response to the Centers for Medicare & Medicaid Services’ (CMS’) proposed rule (CMS-6058-P) implementing program integrity enhancements to the provider enrollment process for Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP).

    MGMA helps create successful medical practices that deliver the highest-quality patient care. As the leading association for medical practice administrators and executives since 1926, MGMA helps improve members’ practices and produces some of the most credible and robust medical practice economic data and data solutions in the industry. Through its national membership and 50 state affiliates, MGMA represents more than 33,000 medical practice administrators and executives in practices of all sizes, types, structures and specialties in which more than 280,000 physicians practice.

    While MGMA supports CMS’ efforts to protect its trust funds by ensuring that unqualified or potentially fraudulent individuals or entities are precluded from billing programs, we are concerned that provisions of this rule are overbroad and would significantly increase the administrative burden on group practices.

    Definition of Affiliation
    CMS proposes to define affiliation as: (1) a five percent or greater direct or indirect ownership interest that an individual or entity has in another organization; (2) a general or limited partnership interest (regardless of the percentage) that an individual or entity has in another organization; (3) an interest in which an individual or entity exercises operational or managerial control over or directly or indirectly conducts the day-to-day operations of another organization; (4) an interest in which an individual is acting as a n officer or director of a corporation; (5) any reassignment relationship under § 424.80. MGMA finds the first four to be reasonable and consistent with both CMS precedents in other contexts, and general usage of the term “affiliation” in other government programs. However, the fifth element of the definition greatly expands the scope of affiliation, in a manner so broad as to render largely irrelevant the first four elements of the definition. Under this fifth element, the current group, and any of its owning or managing employees is tainted by the problems of another group practice, or other provider or supplier, even if the reassigning physician had no ownership interest in, control over, or even awareness of the issues in the other entity which make that entity of concern to CMS.

    5 Year Look Back Period
    CMS proposes a five year look back period for previous affiliations. MGMA is concerned because the event triggering the disclosure is not subject to any look-back limitations which means the disclosable event could have occurred long ago and before the reporting physician had established an affiliation with that entity. MGMA suggests a finite look-back period for disclosable events, which should not precede the date that the physician established a covered affiliation with the relevant entity.

    If the owner or managing employee has committed the violation, it is understandable for them to be required to report it, however, if it is an innocent provider or supplier who had no knowledge or part in the deception, they should not be harmed.

    Uncollected debt
    CMS proposes that a disclosable event should be reported regardless of whether an appeal is pending or whether all parties have agreed to a repayment plan for uncollected debt. MGMA implores CMS to reconsider this proposal as it presumes wrongdoing and ignores any repayment plans, pending litigation or extenuating circumstances that could include any mitigating factors. Additionally, it would be a significant reporting burden, overlook due process, and require enrollees to report actions that may be overturned or unfounded. Requiring enrollees to report actions that have not been completed through the system would unfairly burden them and adversely affect providers or suppliers during the enrollment or revalidation process. By allowing this process to go forward even in the midst of an appeal, it sends the wrong message to providers or suppliers who are trying to pay back an uncollected debt, work through the legal or administrative process to resolve payment disputes, and does not allow for any mistakes on the agency’s or contractor’s part to be taken into account.

    New or Changed Information
    CMS proposes to require providers or suppliers to report new or changed information regarding existing and new affiliations. CMS has not laid out a plan on how the agency will track this type of information or how it should be reported. Since enrollment is highly automated, will there be a staff to check on this? Will the Provider Enrollment Chain and Ownership System (PECOS) recognize these changes? This has potential to be incredibly burdensome on group practices. MGMA urges CMS to provide additional guidance on how this will be implemented.

    Reasonableness
    CMS discusses incorporating a reasonableness standard for reporting disclosable events based on a “knew or should have known” standard. It is not necessary to develop a complex reasonableness test. The reasonableness test should be based on the principle of good faith, and providers or suppliers should not be required or expected to search out information about disclosable events relevant to prior affiliations which they would not be otherwise aware of in the general course of business. Providers or suppliers should not be required to know about disclosable events that occurred before the relevant affiliation commenced or terminated.

    Maximum Reenrollment Bar
    CMS is proposing to extend the maximum reenrollment bar from three years to 10 years, and up to 20 years for a second revocation. CMS asserts authority through precedent for this time frame in 42 CFR § 424.535(a)(3)(ii) – for providers or suppliers who have been convicted of multiple felonies. However, felony convictions involve substantially more due process than the largely administrative adjudications that take place here. It is important that due process be afforded to providers or suppliers before such a draconian bar is imposed. Additionally, under 48 CFR 9.406-4, the period of debarment for a government contractor generally should not exceed three years unless there is a violation of the Drug-Free Workplace Act of 1988 and even then may not exceed five years. We urge CMS to keep the three year maximum enrollment bar in place to maintain consistency and allow due process to providers or suppliers.

    We appreciate the opportunity to provide these comments in response to CMS’ solicitation. We urge CMS to adopt a less broad approach that minimizes administrative and regulatory burdens, and focuses on the sources of greatest risk. Should you or your staff have any questions concerning these matters, please contact Jennifer Pollack at jpollack@mgma.org or 202-293-3450.

    Sincerely,
    Anders Gilberg
    Senior Vice President, Government Affairs

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