On April 25, 2013, CMS announced that, due to technical issues, it is delaying implementation of the Phase 2 ordering and referring deniial editsntil further notice. By way of background, CMS plans to implement edits that will deny claims for Medicare Part B services (including the technical/non-interpretation component of imaging services, lab services, and durable medical equipment) and Part A home health agency services if the ordering/referring physician or other professional is not identified, is not in Medicare's enrollment records, or is not of a specialty type that may order/refer the service/item being billed. While CMS intended to require Medicare contractors to activate these edits effective May 1, 2013, concerns had been raised by physicians and suppliers that they could experience claims denials and delays based on discrepancies between the names of the ordering physician on the 1500 claim form and in Medicare’s enrollment records. CMS expects to announce a new implementation date in the near future.
Proposed Rule Would Reward Medicare Fraud Tipsters up to $9.9 Million, Revise Medicare Provider Enrollment Regulations
Yesterday the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would dramatically increase the potential reward to an individual who provides a tip leading to the recovery of Medicare funds from a current maximum of $1,000 to a maximum of $9.9 million under the Medicare Incentive Reward Program. Since 1998, an individual providing information regarding potential Medicare fraud and abuse to the Department of Health & Human Services’ Office of Inspector General or the Medicare contractor with jurisdiction over the suspected fraudulent provider or supplier may be eligible to receive 10 percent of the Medicare funds ultimately collected from the tip, or $1,000, whichever is less. Pursuant to the proposed rule CMS issued yesterday, an individual furnishing information that otherwise satisfies the requirements set forth in 42 C.F.R. § 420.405 would be eligible to receive 15 percent of a recovery up to $66 million. Therefore, a tipster could receive up to a $9.9 million reward for any information provided regarding suspected Medicare fraud and abuse.
In the proposed Medicare Incentive Reward Program rule, CMS explains that it “tentatively project[s] a net increase in recoveries of $24.5 million per year as a result of the proposed changes.” In addition, CMS notes that it is modeling the proposed Incentive Reward Program changes on a “highly successful” Internal Revenue Services (IRS) reward program that returned “far greater sums than the existing Medicare [Incentive Reward Program].” Notably, since the implementation of the current Medicare Incentive Reward Program in July 1998, CMS has collected only $3.5 million; in contrast, between 2007 and 2012, the IRS has collected almost $1.6 billion through its reward program. CMS states in the preamble that it proposes to clarify that it will not pay an award if the same or substantially similar information was the basis for a relators share in a qui tam lawsuit under the federal False Claims Act or a state False Claims Act, or is the basis for a pending state or federal False Claims Act suit. However, the proposed regulatory language that would codify this change, found at proposed 42 C.F.R. § 420.405(b)(3), does not specify that this provision would apply to state False Claims Acts.
The proposed rule also would pay the reward amount only to the first individual who makes a report. In addition, among other proposed changes to the regulations found at 42 C.F.R. § 420.405, CMS proposes to emphasize that it has exclusive discretion in determining the amount of a reward and whether the reward criteria are met. The existing regulation provides for numerous other exceptions and conditions and generally excludes federal and state law enforcement officials, federal government employees, and federal contractors, from eligibility.
CMS also proposes several revisions to Medicare’s provider enrollment regulations, such as:
- Allowing CMS to deny the enrollment of providers, suppliers, and owners affiliated with an entity that has unpaid Medicare debt;
- Expanding the instances under which a felony conviction can serve as a basis for denial or revocation of a provider or supplier's enrollment;
- Enabling CMS to revoke Medicare billing privileges if it determines that the provider or supplier has a pattern or practice of submitting claims for services that fail to meet Medicare requirements; and
- Limiting the ability of ambulance suppliers to “backbill” for services performed prior to enrollment.
The proposed rule will be published in the April 29, 2013 edition of the Federal Register, and comments will be accepted for 60 days thereafter (June 28, 2013).
Effective May 1, 2013, Medicare contractors will activate edits that will deny claims for Medicare Part B (including imaging and lab services), DME, and Part A home health agency (HHA) services if the ordering/referring physician or other professional is not identified, is not in Medicare's enrollment records, or is not of a specialty type that may order/refer the service/item being billed. Concerns have been raised by physicians and suppliers that they could experience claims denials and delays after May 1 based on discrepancies between the names of the ordering physician on the 1500 claim form and in Medicare’s enrollment records. CMS is holding a March 20, 2013 National Provider Call to discuss these new requirements.
CMS is extending the 2013 Medicare participation enrollment period for suppliers of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) until April 15, 2013. By way of background, a supplier that signs a participation agreement commits to accepting the Medicare Part B rate as payment in full for all beneficiaries. Changes in a supplier’s participation status can only be made during the annual open enrollment period. While CMS is extending the deadline because some suppliers apparently were not aware of a previous deadline extension to February 15, the new announcement gives suppliers another opportunity to examine their participation status in light of recent Medicare payment developments, including sequestration and upcoming Medicare cuts for retail diabetic testing supplies. Any change in election status will be effective January 1, 2013, but CMS will not reprocess claims already filed.
CMS has released the revised CMS-855S Medicare supplier enrollment application, version 01/13. Suppliers may use the 07/11 version of the CMS-855S through May 7, 2013, at which time any information received on the obsolete form will be returned to the supplier, according to the National Supplier Clearinghouse. CMS also has posted an updated (1/13) version of the CMS 855O form, the Medicare Enrollment Application - Registration for Eligible Ordering and Referring Physicians and Non-Physician Practitioners.
On January 8, 2013, the Obama Administration published its latest semiannual regulatory agenda, outlining planned regulatory initiatives in a number of policy areas. The Federal Register version of the agenda includes only a portion of the regulations in the pipeline, however; the full agenda has been posted on the Office of Management and Budget (OMB) web site. Major Department of Health and Human Services (HHS) regulations are highlighted after the jump.
- An HHS Office of Inspector General (OIG) proposed rule that would add new/modify existing safe harbors under the anti-kickback statute; add new/revise existing regulations governing OIG's authority to impose civil money penalties and assessments; add new/revise existing regulations governing OIG's exclusion authority; and codify new exceptions to the beneficiary inducement prohibition (expected July 2013);
- A final Centers for Medicare & Medicaid Services (CMS) rule implementing Affordable Care Act (ACA) provisions related to Medicaid reimbursement for covered outpatient drugs (expected in August 2013);
- A CMS proposed rule to establish Medicare payment safeguards to prevent providers and suppliers that do not meet Medicare requirements from remaining enrolled in or submitting claims to Medicare (expected May 2013);
- Proposed emergency preparedness requirements for Medicare and Medicaid participating providers and suppliers (expected in July 2013);
- A final CMS rule establishing requirements for disclosure of skilled nursing facilities' ownership (expected May 2013);
- A final rule on long-term care facility agreements with hospice agencies (expected October 2013);
- A proposed rule to establish a prospective payment system for Federally Qualified Health Centers (expected June 2013);
- Annual Medicare payment update rules (various dates);
- Various rules implementing insurance-related provisions of the ACA (various dates);
- A final rule modifying HIPAA privacy, security, enforcement, and breach notification rules (expected but not released in December 2012);
- An advance notice of proposed rulemaking to establish a methodology allowing an individual harmed by an offense punishable under HIPAA to receive a percentage of any civil money penalty or monetary settlement collected (expected March 2013);
- A final rule to enhance human subjects research protections (expected April 2013); and
- A Food and Drug Administration (FDA) final rule establishing a unique device identification system for medical devices (expected May 2013).
There are also some surprises on the Administration’s list of “long-term actions” – including the long-overdue final ACA “Sunshine Act” rule requiring applicable manufacturers of drugs, devices, biologicals, or medical supplies to annually report certain payments to physicians or teaching hospitals (“final action” listed as December 2014). Other long-term actions include a final rule implementing ACA requirements related to reporting and returning of overpayments (February 2015); a variety of rules dealing with the 340B discount drug program (timing listed as “to be determined”); and a final HIPAA privacy rule on accounting for disclosures under the Health Information Technology for Economic and Clinical Health Act (TBD).
CMS recently published a notice announcing a $532.00 calendar year 2013 application fee for institutional providers that are initially enrolling in the Medicare or Medicaid program or the Children's Health Insurance Program (CHIP); revalidating their Medicare, Medicaid or CHIP enrollment; or adding a new Medicare practice location. This fee is required with any enrollment application submitted on or after January 1, 2013 and on or before December 31, 2013.
The 2013 Medicare Open Enrollment Period runs from October 15 to December 7, 2012. To help beneficiaries make informed choices, CMS has posted updated quality rating information for Medicare Advantage plans and Part D prescription drug plans for the coming year. An HHS press release summarizing the data and providing links to additional information is available here.
On October 10, 2012, CMS will hold a National Provider Call on Medicare Provider Enrollment. The call will cover the following topics: Revalidation; Billing for Ordered/Referred Services; and PECOS Enhancements. Registration is required.
CMS is proposing changes to the Medicare enrollment application for DMEPOS suppliers (CMS 855S) to simplify and clarify the current data collection and to remove obsolete questions. According to CMS, the majority of the revisions are non-substantive in nature (e.g., spelling and formatting corrections). Comments on the forms will be accepted until June 4, 2012.
The GAO has issued a report entitled “Medicare Program Integrity: CMS Continues Efforts to Strengthen the Screening of Providers and Suppliers.” The GAO describes how CMS and its contractors use provider and supplier enrollment information to prevent improper payments, along with factors that may affect the usefulness of this information. The report also provides an update on CMS’s progress in implementing new provider and supplier enrollment screening procedures mandated by the ACA. For instance, CMS informed the GAO that it plans to contract with two Federal Bureau of Investigation-approved contractors to conduct fingerprint-based criminal background checks of high-risk providers and suppliers by the end of 2012. CMS also plans to extend the surety bond requirement to high-risk providers and suppliers beyond DMEPOS suppliers (potentially impacting home health agencies, independent diagnostic testing facilities, and outpatient rehabilitation facilities). The GAO also reports that CMS has charged a new automated screening contractor with, among other things, identifying additional data sources for screening checks (e.g., financial, tax, and business data sources). CMS also contracted with a site visit contractor to perform nationwide physical site visits for all providers and suppliers, except DMEPOS suppliers, in the moderate- and high-risk screening categories.
CMS Finalizes Changes in Medicare/Medicaid Provider and Supplier Enrollment, Ordering, Documentation Requirements
CMS published a final rule on April 27, 2012 that updates regulations regarding Medicare and Medicaid provider and supplier enrollment, ordering and referring, documentation requirements, and provider agreements, effective June 26, 2012. The rule modifies and finalizes several ACA provisions implemented in the May 5, 2010 interim final rule with comment period. Among other things, the rule:
- Requires all providers of medical or other items or services and suppliers that qualify for a National Provider Identifier (NPI) to include their NPI on all Medicare and Medicaid enrollment applications and claims.
- Requires physicians and other professionals who are permitted to order and certify Medicare covered items and services to be enrolled in Medicare. The final rule modifies a requirement that had been in the interim final rule that the ordering provider be registered in the Medicare Provider Enrollment, Chain, and Ownership System (PECOS). While the rule still requires ordering physicians and other eligible professionals to be enrolled in the Medicare program (or to maintain a valid opt-out record), enrollment in PECOS is no longer required.
- Mandates document retention and provision requirements for certain providers and suppliers that order and certify items and services for Medicare beneficiaries. The provision specifically applies to durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS), laboratory, imaging, and home health services – importantly, CMS has dropped an earlier reference to “specialist services” being subject to these requirements. The final rule also clarifies that the documentation requirement is not the responsibility of the physicians interpreting imaging studies -- only the technical component entity has to meet these requirements. Under the final rule, necessary documentation must be retained for 7 years from the date of service (rather than the date of the order or certification as provided under the interim final rule). A provider or supplier that does not meet the documentation retention requirements is subject to revocation for not more than 1 year for each act of noncompliance.
CMS has announced a series of upgrades to the Medicare online enrollment system, known as PECOS (“Provider Enrollment, Chain, and Ownership System”), that are intended to reduce data entry time and increase access to information.
The CMS Atlanta Regional Office is hosting a symposium in Orlando, Florida on December 14 -16, 2011 entitled “Empowering Minorities -- Promoting Better Health, Better Care, Lower Cost for Medicare Beneficiaries in their Communities." The symposium will feature speakers, panels, and breakout sessions covering a wide range of topics such as Medicare Fraud & Abuse Training, the Affordable Care Act, Medicare Provider Enrollment, Quality Care, and DMEPOS issues.
CMS has announced that the 2012 application fee for institutional providers (excluding physicians and nonphysician practitioners) enrolling in Medicare, Medicaid, or the Children's Health Insurance Program (CHIP) will be $523 – up from $505 in 2011. CMS uses a broad definition of institutional entities subject to the application fee; it applies to “any provider or supplier that submits a paper Medicare enrollment application using the CMS-855A, CMS-855B (not including physician and non-physician practitioner organizations), CMS-855S or associated Internet-based PECOS enrollment application.” As authorized under CMS’s February 2011 final Medicare/Medicaid/CHIP provider screening rule, institutional providers must pay the application fee when initially enrolling in the Medicare or Medicaid programs or CHIP; revalidating their Medicare, Medicaid or CHIP enrollment; or adding a new Medicare practice location (unless a hardship exemption applies).
CMS has posted a list of names/National Provider Identifiers of Medicare providers that have been sent a request to revalidate their Medicare enrollment information. CMS also has announced that as part of its revalidation efforts, all suppliers and providers who are not currently receiving electronic funds transfer (EFT) payments will be identified and required to submit the CMS 588 EFT form with the Provider Enrollment Revalidation application.
Revised Medicare Provider-Supplier Enrollment Application, New Application for Ordering/Referring Released
CMS has announced final approval of revised versions of the Medicare Provider-Supplier Enrollment Applications (CMS-855). While the revised forms may be used immediately, the previous 2008 versions may be used through October 2011. In addition, CMS has released a new CMS-855O application form to be used for the sole purpose of enrolling to order and refer items and/or services to Medicare beneficiaries; this form must be used immediately.
The OIG has issued two new reports that reveal the plans of CMS to conduct more unannounced site visits of independent diagnostic testing facilities (IDTFs) nationally. The reports describe findings that in Miami and Los Angeles, IDTFs did not comply with Medicare standards requiring IDTFs to: (1) maintain a physical facility at the location on file with CMS, and (2) be open during business hours. IDTFs that do not comply with Medicare standards are subject to a variety of administrative actions, including revocation of their Medicare billing privileges. In Miami, unannounced OIG site visits in May 2010 found that 27 of 92 area IDTFs failed to comply with the selected Medicare standards. The OIG’s inspections in Miami came at the same time that CMS was conducting site visits to all IDTFs in South Florida as part of the “South Florida High Risk Enrollment Project.” As a result of its special enrollment project and routine oversight, CMS took action against 23 of the 27 noncompliant IDTFs that the OIG identified, but three IDTFs still received Medicare payments while CMS was revoking their billing privileges. Separately, OIG site visits in May and June of 2010 found that 46 of 132 Los Angeles-area IDTFs were noncompliant with the two Medicare standards. In both reports, the OIG recommended that CMS periodically conduct unannounced site visits to IDTFs and take action against noncompliant IDTFs indentified by the OIG. CMS concurred with these recommendations. In particular, CMS states that it anticipates increasing the frequency of unannounced site visits to IDTFs, as authorized by its final February 2, 2011 provider/supplier screening rule that classifies IDTFs as “moderate risk” providers subject to unannounced site visits. According to CMS’s response to the OIG, CMS is soliciting a contractor to conduct site verifications on a national scale, and it plans to begin systematically screening enrollment data with public source data to indentify changes that could warrant further investigation. CMS also announced that it is exploring options to use payment suspensions in conjunction with revocation actions for providers and suppliers that are found to be nonoperational. The OIG also recommended that CMS impose a moratorium on the enrollment of IDTFs in the Los Angeles area (the OIG did not recommend a moratorium in Miami due to the existing CMS special enrollment project). CMS disagreed with the enrollment moratorium recommendation at this time, but CMS stated that it would consider the recommendation as it develops criteria for potential enrollment moratoria for a number of locations, including Los Angeles. CMS would be required to publish a Federal Register notice if it were to announce any such moratorium.
CMS has issued a new transmittal to update its timeline for implementing claims edits that will deny claims for services ordered or referred by a physician or other eligible professional who does not have an approved file in PECOS. The transmittal confirms an earlier CMS list-serve announcement that CMS will not implement the edits (that could cause nonpayment for services ordered by practitioners not in PECOS) on January 3, 2011. Instead, CMS has established a new "implementation placeholder date" of July 5, 2011, which CMS notes will "give CMS more flexibility to determine the appropriate date for nonpayment of claims that fail the ordering/referring provider edits."
CMS has issued a transmittal to contractors and an educational article providing further guidance to suppliers of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) regarding accreditation requirements. Effective for claims with dates of service on or after July 5, 2011, CMS is implementing accreditation edits that will automatically deny claims for certain DMEPOS codes unless: (1) the DMEPOS supplier has been identified as accredited for the timeframe that covers the date of service on the claim; or (2) the DMEPOS supplier is currently exempt from meeting the accreditation requirements.