Enrollment Screening
Under the Rule, all providers and suppliers would be placed in one of three risk levels (limited, moderate, and high), based on an assessment of their overall risk of fraud, waste and abuse. Screening procedures would differ for every risk level, with high risk providers and suppliers receiving the most attention.
Surgery centers, physicians and group practices are among providers that would be considered limited risk providers to government insurances programs. As a limited-risk entity, these providers would undergo the following screening procedures: (1) verification that a provider or supplier meets any applicable Federal regulations, or State requirements for the provider or supplier type prior to making an enrollment determination; (2) verification that a provider or supplier meets applicable licensure requirements; and (3) database checks on a pre- and post-enrollment basis to ensure that providers and suppliers continue to meet the enrollment criteria for their provider/supplier type.
Moderate risk entities would include community mental health centers, hospice organizations and independent diagnostic testing facilities (except those that are publicly traded). Moderate risk entities would undergo the same screening procedures as limited risk entities and will undergo unannounced pre- and/or post-enrollment site visits by Medicare contractors.
High risk entities would include prospective (newly enrolling) home health agencies and suppliers of DMEPOS (except those that are publicly traded). In addition to the screening tools applicable to limited and moderate risk entities, Medicare contractors would use the following screening tools in the enrollment process for high risk entities: (1) criminal background check; and (2) submission of fingerprints using the FD-258 standard fingerprint card.
The new screening procedures will be applicable to newly enrolling providers and suppliers, beginning on March 25, 2011. The new screening procedures will also be applicable beginning on March 25, 2011 for those providers and suppliers currently enrolled in Medicare, Medicaid and CHIP who revalidate their enrollment information. CMS is however delaying implementation of the fingerprint-based criminal history record check requirement until 60 days following the publication of additional regulatory guidance.
Judd Harwood is an associate in Balch & Bingham, LLP's Health Care Law Practice Group.
Application Fees
Beginning March 25, 2011, "institutional providers" must include a non-refundable application fee with any enrollment, revalidation, or new location application, or otherwise request a hardship exception. CMS defines "institutional provider" as any provider or supplier that would be submitting CMS Forms 855-A, 855-B, or 855-S. CMS interprets this definition to include, but not be limited to: community health centers; hospitals (including acute care facilities and critical access hospitals); and independent diagnostic testing facilities. The application fee is not applicable to physicians or non-physician practitioners. The Rule sets the initial application fee at $500 for 2010, with subsequent CPI adjustments thereafter.
Moratoria on Enrollment
Under the Rule, CMS may impose a temporary moratorium for a period of six months with additional extensions where (1) CMS, based on its review of existing data, identifies a trend that appears to be associated with a high risk of fraud, waste, or abuse; (2) a state Medicaid program has imposed a moratorium on a group of Medicaid providers or suppliers that are also eligible to enroll in the Medicare program; (3) where a State has imposed a moratorium on enrollment in a particular geographic area, or on a particular type of provider or supplier, or both; or (4) where CMS, in consultation with the Office of the Inspector General or Department of Justice, and with the approval of the CMS Administrator, identifies a particular geographic area or a particular provider or supplier type, as having significant potential for fraud, waste or abuse in the Medicare program.
The Rule expressly states that there will be no judicial review of temporary moratoria. Providers or suppliers affected by such moratoria may administratively appeal adverse determinations based on the imposition of temporary moratoria, up to and including the Departmental Appeal Board level of review.
Suspension of Payments
Finally, the Rule implements Section 6402(h) of the PPACA which establishes mechanisms for suspension of Medicare and Medicaid payments to providers and suppliers pending investigation of "credible allegations of fraud." The Rule broadly defines "credible allegation of fraud" to encompass allegations from any source, such as, (1) fraud hotline complaints, (2) claims data mining, (3) and patterns identified through provider audits, civil false claims cases, and law enforcement investigations. The Rule states that allegations "are considered to be credible when they have indicia of reliability." Unless providers and suppliers under investigation can show "good cause" not to have their payments suspended, they are at risk of having payments suspended for allegations that merely have "indicia of reliability."
In the event of suspension, CMS will be required every 180 days to confirm that the matter continues to be under investigation and to evaluate whether there is good cause to not continue the suspension. The Rule contemplates that a suspension can continue for 18 months, and even at that point could allow the suspension to continue in some cases.