The OIG published a notice July 11, 2014 announcing that it is considering revising its nonbinding criteria, established in 1997, outlining the circumstances under which the OIG may exercise its permissive authority under Section 1128(b)(7) of the Social Security Act to exclude an individual or entity from participation in the federal health care programs for engaging in conduct described in sections 1128A and 1128B of the Act (e.g., submitting or causing the submission of false or fraudulent claims or soliciting or paying kickbacks in violation of the Federal Anti-Kickback Statute). Since 1997, OIG has used these criteria in False Claims Act cases and administrative matters to evaluate whether to impose a permissive exclusion or release this authority in exchange for the defendant’s entering into a Corporate Integrity Agreement with OIG. The OIG suggests that “updated guidance could better reflect the state of the health care industry today, including the changes in legal requirements and the emergence of the health care compliance industry.” The OIG is particularly interested in input on: (1) whether there should be differences in the criteria for individuals and entities and (2) whether and how to consider a defendant's existing compliance program. The OIG will accept comments through September 9, 2014. After reviewing comments, the OIG will decide whether and how to revise its non-binding exclusion criteria.
On the heels of its proposed rule to expand its health program exclusion authority, the Office of Inspector General (OIG) of the Department of Health and Human Services has published a proposed rule that would amend the health care program civil monetary penalty (CMP) regulations. The rule would codify the OIG’s expanded statutory authority under the Affordable Care Act to impose CMPs on providers and suppliers and would allow for significant penalties in a variety of scenarios, some of which could extend beyond what is currently permitted.
Reed Smith attorneys have prepared a Client Alert summarizing and analyzing the OIG’s proposed rule, including the various scenarios under which CMPs could be issued under the proposed regulations, such as: failure to report and return an overpayment; failure to grant OIG timely access to records upon request; ordering or prescribing items or services while excluded from a federal health care program, as well as arranging or contracting with an individual or entity who meets this criteria; making false statements or omitting or misrepresenting material facts in an application, bid, or contract; and failing to submit or certify drug-pricing and product information in a timely manner. In addition, the alert covers the changes in technical language proposed by OIG to clarify and more clearly define the scope of CMP regulations.
The Client Alert is available here.
On May 9, 2014, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) published a proposed rule that would significantly expand the exclusion regulations applicable to persons or entities that receive, directly or indirectly, funds from federal health care programs (the Proposed Rule). The Affordable Care Act (ACA) expanded the OIG’s authority for exclusion, and authorized the use of testimonial subpoenas in investigations of exclusion cases. In this Proposed Rule, the OIG incorporates these statutory changes, revises the definitions applicable to exclusions, proposes early reinstatement procedures, and offers a number of proposed policy changes as to when and how exclusions may take place.
Reed Smith has prepared a Client Alert that provides an overview of the Proposed Rule, including: proposed revisions to definitions; new grounds for exclusion; clarifications to existing regulations to add mitigating and aggravating factors; early reinstatement procedures; and proposed procedural changes in the OIG’s exclusion authorities. In particular, we discuss the OIG’s assertion that there should be no statute of limitations within which it would have to seek exclusion. This limitless look-back authority could place a tremendous burden on providers and suppliers, since their conduct and compliance efforts could be second-guessed many years into the future, when supporting documentation and witnesses may be long gone. We also discuss how these proposed changes to the OIG’s exclusion authorities could impact the debarment authority applicable to government contracts more generally.
The Client Alert is available here.
As previously reported, the Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) published final rules in December amending Anti-Kickback Statute (AKS) and Stark Law regulations permitting certain arrangements involving the donation of interoperable electronic health record (EHR) software or information technology and training services. Reed Smith has prepared a summary of the final rules, including a side-by-side comparison of the EHR AKS Safe Harbor and the Stark Law’s EHR Exception that highlights the recent revisions.
The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has published its annual solicitation of recommendations for new or modified safe harbor provisions under the federal anti-kickback statute, as well as potential topics for new OIG Special Fraud Alerts. Comments will be accepted until February 25, 2014. For a status report on prior public safe harbor recommendations, see Appendix F of the OIG's Fall 2013 Semiannual Report to Congress.
On December 27, 2013, the Office of Inspector General and the Centers for Medicare & Medicaid Services each published, in the Federal Register, a final rule that amends regulations protecting, from the Anti-Kickback Statute and Stark law, certain arrangements involving the donation of interoperable electronic health records (EHR) software or information technology and training services related to such EHR software. The final rules:
- Extend the protections of the Stark law exception (42 C.F.R. § 411.357(w)) and the Anti-Kickback safe harbor (42 C.F.R. § 1001.952(y)) from December 31, 2013 to December 31, 2021 (the “sunset” provisions)
- Exclude laboratory companies from the types of entities that may donate EHR items and services
- Update the provisions under which an EHR donor or recipient can ascertain, with certainty, that EHR is interoperable pursuant to the exception and safe harbor (the “deeming” provisions)
- Remove the requirements that donated EHR include electronic prescribing capability
- Clarify the requirement prohibiting any action that limits or restricts the use, compatibility, or interoperability of donated items or services
With the exception of the amendments to the sunset provisions, which go into effect December 31, 2013, the amended regulations will be effective as of March 27, 2014.
Reed Smith will prepare a comprehensive Client Alert on the final rules, which will be published shortly.
Reed Smith lawyers have significant experience advising clients on EHR technology issues and will continue to monitor regulatory changes in this area. For more information regarding how we can assist you, please contact your principal Reed Smith lawyer or a lawyer listed in this publication.
A new OIG report estimates that Medicare could realize significant savings if drug manufacturers were required to pay rebates on Medicare Part B drugs, similar to rebates under the Medicaid program. Specifically, Medicare could have collected $3.1 billion in 2011 if manufacturers had been required to pay rebates based on average manufacturer price (AMP) for 60 high-expenditure Part B drugs, while rebates based on average sales price (ASP) for the same drugs could have generated $2.7 billion in payments. In the report, the OIG recommends that CMS examine establishing such a Part B drug rebate program and, if appropriate, seek legislative change. CMS rejected this suggestion, noting that developing such a plan – which would require new legislative authority -- would necessitate analysis of the effects of making fundamental changes to the Part B claims payment system, the impact on providers, and the impact on access to care. CMS maintains that it is “unable to devote significant administrative resources at this time to a proposal that is neither a provision of current law or actively under consideration.” (The Administration has, on the other hand, advocated rebates for Medicare Part D drugs furnished to low-income subsidy beneficiaries as part of its FY 2014 budget proposal.)
Almost two-thirds of critical access hospitals (CAHs) would not meet Medicare CAH location requirements if they were required to re-enroll today, according to the OIG. Many of these rural hospitals were permanently exempted from CAH distance requirements under previous authority of states to designate “necessary provider” (NP) CAHs. Medicare reimburses CAHs at 101% of their reasonable costs; if CMS had the authority to decertify CAHs that were 15 or fewer miles from their nearest hospitals in 2011, the OIG estimates that Medicare would have saved $449 million. The OIG recommends that CMS take several steps to “ensure that the only CAHs to remain certified would be those that serve beneficiaries who would otherwise be unable to reasonably access hospital services.” For instance, the OIG recommends that CMS seek legislative authority to remove NP CAHs’ permanent exemption from the distance requirement; CMS notes that the President’s proposed FY 2014 budget would decertify any CAHs located fewer than 10 miles from another hospital or CAH (and reduce payment to all remaining CAHs to 100% of reasonable cost). CMS also discusses steps it has already taken to implement OIG recommendations to periodically reassess CAHs for compliance with all location-related requirements and to ensure that CMS applies a uniform definition of “mountainous terrain” to all CAHs. CMS disagreed with an OIG recommendation to seek legislative authority to revise the CAH Conditions of Participation to include alternative location-related requirements.
A recent OIG report examines the extent of improper Medicare reimbursement for diabetes test strips (DTS), including the effect of mail-order DTS being subject to competitive bidding in nine geographic areas beginning in 2011 (CMS subsequently implemented a national competitive bidding program for mail-order DTS, effective July 1, 2013). According to the OIG, in 2011, Medicare inappropriately allowed $6 million for DTS claims billed for beneficiaries without a documented diagnosis code for diabetes, or that inappropriately overlapped with an inpatient hospital stay or an inpatient skilled nursing facility stay. Moreover, the OIG identified $425 million in Medicare-allowed DTS claims in 2011 that had characteristics of questionable billing, such as claims in excess of utilization guidelines, claims at perfectly regular intervals, or overlapping claims for the same beneficiary. The OIG observes that the Medicare competitive bidding program appears to have been successful in reducing questionable billing for mail-order DTS, since Medicare allowed claims for mail order DTS for suppliers exhibiting questionable billing in CBAs fell from $33.2 million to $4.3 million between 2010 and 2011. The OIG recommended that CMS take additional action to address inappropriate DTS claims, such as expanding supplier education, enforcing claims edits, and increasing monitoring of DTS suppliers’ billing. CMS also agreed to take appropriate action regarding inappropriate Medicare DTS claims and suppliers identified by the OIG, including referral of questionable claims to the Recovery Auditors and Medicare Administrative Contractors (MACs).
Two recent OIG reports point out the savings that state Medicaid programs could attain if they based reimbursement for DME, prosthetics, orthotics, and supplies (DMEPOS) on Medicare competitive bidding payment amounts – although at least one state is pushing back on this idea. In the first report, “Medicaid DMEPOS Costs May be Exceeding Medicare Costs in Competitive Bidding Areas,” the OIG calculated the potential savings Texas could have achieved in 2011 if it adopted Medicare DMEPOS bidding prices for selected items of DMEPOS. According to the OIG, Texas Medicaid fee-schedule could have saved approximately $2 million (state/federal shares combined) in the Dallas/Fort Worth area if it had based Medicaid rates on the Medicare DMEPOS competitive bidding amounts for 32 DMEPOS items covered under both programs. The OIG states that its report provides “a tangible example of potential State and Federal savings for Medicaid programs if the programs were to use the Medicare Competitive Bidding payment amounts for DMEPOS items.” This report did not include recommendations or state reaction.
In the second report, “New Jersey Medicaid Program Could Achieve Savings by Reducing Home Blood-Glucose Test Strip Prices,” the OIG estimates that the New Jersey Medicaid program could have saved approximately $1.8 million to $2.7 million in 2011 by reducing home blood-glucose test strip reimbursement rates to retail rates or by establishing a competitive bidding program for test strips. Such policy changes for test strips also could reduce Medicaid managed care organization reimbursement rates by up to 70%. However, the New Jersey Department of Human Services disagreed with the OIG’s recommendations to align state Medicaid reimbursement with average retail price or Medicare competitive bidding pricing, citing, among other things, doubts about the feasibility of attaining such savings and concerns about patient access and the impact on proper diabetes management.
The OIG has called on CMS to strengthen activities to prevent improper Medicare payments, including enhancements to the Recovery Audit Contractor (RAC) program. For instance, the OIG notes that RACs identified half of all claims they reviewed in FYs 2010 and 2011 as having resulted in improper payments totaling $1.3 billion. While CMS took corrective actions to address the majority of identified vulnerabilities, the agency did not evaluate the effectiveness of these actions, however, so high levels of improper payments may continue. The OIG also raised concerns about CMS failure to act on all referrals of potential fraud that it received from RACs, along with gaps in CMS evaluations of RAC performance on contract requirements. The OIG recommends that CMS: address identified vulnerabilities; ensure that RACs refer all appropriate cases of potential fraud; take appropriate action on RAC referrals of potential fraud; and enhance RAC performance evaluation. CMS generally concurred with the OIG recommendations. The report, “Medicare Recovery Audit Contractors and CMS’s Actions to Address Improper Payments, Referrals of Potential Fraud, and Performance,” is available here.
In a recent report, “Medicaid Drug Pricing in State Maximum Allowable Cost Programs,” the OIG examines options for controlling state Medicaid prescription drug costs, particularly given a surge in Medicaid enrollment expected in the coming years as a result of the ACA. The OIG highlights the value of state Maximum Allowable Cost (MAC) programs as an alternative to federal upper limit (FUL) pricing, especially since CMS is years behind in implementing AMP-based federal upper limit (FUL) amounts under the ACA. The OIG found that aggregate pre-ACA FUL amounts were on average nearly double state MAC prices in January 2012, although the post-ACA FUL amounts (which have not been implemented) were lower than MAC prices on average. The OIG also notes that states could achieve additional cost savings by using more aggressive MAC pricing formulas and inclusion criteria, particularly along the lines of Wyoming’s program, which sets MAC prices by considering (1) acquisition cost plus a markup, (2) wholesale acquisition cost (WAC) minus a percentage, (3) average wholesale price (AWP) minus a percentage, or (4) AMP plus a markup. According to the OIG, 39 states would have saved $483 million (excluding dispensing fees) in the first half of 2011 if they had used Wyoming’s MAC criteria. The OIG recommends that CMS complete implementation of the post-ACA FUL amounts; CMS concurred and said it plans to finalize these FULs in the near future. CMS also concurred with OIG's recommendation to encourage states to reevaluate their Medicaid programs to identify additional cost saving opportunities, and noted its plans to release a related informational bulletin to the states in the near future.
The HHS Office of the Inspector General (OIG) has issued a report entitled “Medicare Could Save Millions by Strengthening Billing Requirements for Canceled Elective Surgeries.” Based on a review of 100 claims, the OIG estimates that Medicare made $38.2 million in Part A inpatient hospital payments in calendar years 2009 and 2010 for short-stay, canceled elective surgery admissions that were not reasonable and necessary. Specifically, the OIG found that for 80 of the 100 sampled claims, Medicare made payments totaling $345,717 for hospital inpatient claims involving canceled elective surgeries when the condition of the patient was not severe enough to warrant an inpatient admission (i.e., a clinical condition did not exist on admission or a new condition did not emerge after admission that required inpatient care). The OIG recommends that CMS: (1) adjust sampled claims representing overpayments to the extent allowed under the law; (2) strengthen guidance to hospitals; (3) resolve remaining non-sampled claims and recover overpayments to the extent feasible and allowed under the law; and (4) instruct Medicare administrative contractors to emphasize to hospitals the need for stronger utilization review controls for claims that include admissions for elective surgeries that did not occur. CMS generally agreed with the OIG’s recommendations.
A recent OIG report examined “Hospitals’ Use of Observation Stays and Short Inpatient Stays for Medicare Beneficiaries.” The report was conducted in response to concerns about hospitals’ use of observation stays, which may be resulting in Medicare beneficiaries paying more as outpatients than if they were admitted as inpatients, and which may prevent beneficiaries from qualifying under Medicare for SNF services following discharge from the hospital. In addition, CMS is concerned about improper payments for short inpatient stays when the beneficiaries should have been treated as outpatients. Based on a review of claims from 2012, the OIG found that Medicare beneficiaries had 1.5 million observation stays, commonly spending one night or more in the hospital. Beneficiaries had an additional 1.4 million long outpatient stays; some of these may have been observation stays. Beneficiaries also had 1.1 million short inpatient stays, which the OIG notes typically cost Medicare and beneficiaries more than observation stays. In addition, beneficiaries had more than 600,000 hospital stays that lasted 3 nights or more but did not qualify them for SNF services, while Medicare inappropriately paid $255 million for SNF services for which beneficiaries did not qualify (CMS will refer these SNFs to CMS so the agency can look into recoupment). The OIG points out that that the CMS proposed IPPS rule for FY 2014 (which subsequently was finalized, as discussed above) would substantially affect how hospitals bill for these stays. While the number of short inpatient stays would be significantly reduced under the proposed rule, the number of observation and long outpatient stays may not be reduced if outpatient nights are not counted towards the proposed two night presumption. The OIG suggests that CMS consider how to ensure that beneficiaries with similar post-hospital care needs have the same access to and cost sharing for SNF services. In a related matter, a nationwide class action lawsuit filed November 3, 2011 on behalf of 14 named seniors by the Center for Medicare Advocacy and the National Senior Citizens Law Center challenging CMS’s observation day policy and practice is still pending in federal district court. Bagnall v. Sebelius, No. 11-1703 (D. Conn. filed Nov. 3, 2011). The lawsuit alleges that the use of observation status violates the Medicare Act, the Freedom of Information Act, the Administrative Procedure Act, and the Due Process Clause of the Fifth Amendment to the Constitution.
The OIG has issued a report entitled “Data and Safety Monitoring Boards in NIH Clinical Trials: Meeting Guidance, But Facing Some Issues.” The report examines the effectiveness of data and safety monitoring boards (DSMB) – or committees of experts that provide ongoing reviews of clinical trial data to ensure the safety of study subjects and validity and integrity of data. Based on a review of 44 National Institutes of Health (NIH) funded Phase III multi-site clinical trials that were completed in 2009 and 2010 that entailed potential risk, the OIG concluded that DSMBs met general NIH guidance in this area, including with regard to the experience of DSMB members. The OIG identified several potential issues, however, including that NIH participation in closed DSMB meetings diminishes the appearance of independence and not all NIH Institutes and Centers (IC) policies reference DSMB access to unmasked data. Based on these findings, the OIG recommends that NIH: direct ICs to delineate the circumstances in which IC staff should participate in DSMB meetings; direct IC DSMB policies to explicitly reference DSMB access to unmasked data, and identify ways to recruit and train new DSMB members. NIH concurred with the recommendations.
On May 17, 2013, the HHS Office of Inspector General (OIG) published a final rule amending current regulations prohibiting State Medicaid Fraud Control Units (MFCU) from using federal matching funds to identify fraud through screening and analyzing State Medicaid data (known as data mining). In order to “support and modernize MFCU efforts to effectively pursue Medicaid provider fraud,” the OIG is permitting federal financial participation (FFP) in costs of defined data mining activities under specified circumstances. In addition, the OIG is finalizing requirements that MFCUs annually report costs and results of approved data mining activities to the OIG. The rule is effective on June 17, 2013.
The OIG has issued its latest Semiannual Report to Congress, covering the period of October 1, 2012 to March 31, 2013. For the first half of FY 2013, the OIG reported expected recoveries of about $3.8 billion, consisting of more than $521 million in audit receivables and about $3.28 billion in investigative receivables (which includes $642.3 million in non-HHS investigative receivables, such as states’ shares of Medicaid restitution). The OIG excluded 1,661 individuals and entities from participation in federal health care programs; 484 criminal actions for crimes against HHS programs; and 240 civil actions (including false claims and unjust-enrichment lawsuits filed in federal district court, civil monetary penalty settlements, and administrative recoveries related to provider self-disclosure matters). The report also summarizes significant investigation and audit activities for the period.
The OIG has issued an ACA-mandated report on Medicare Part D prescription drug plan and MA drug plan coverage of drugs commonly used by full-benefit dual-eligible individuals (that is, individuals eligible for Medicare and Medicaid and who receive full Medicaid benefits and Medicare premium and cost-sharing assistance). The OIG determined that for 2013, Part D/MA plan formularies include 96% of 195 commonly-used drugs, with 64% of the commonly-used drugs included in all such formularies. Plans applied utilization management tools to 28% of the unique drugs reviewed in 2013, compared to 24% in 2012 (mainly attributable to an increase in the use of quantity limits).
Providers and suppliers use G modifiers on claims they expect to be denied as either not “reasonable and necessary” (GA and GZ modifiers) or because the items or services are not covered by Medicare (GY and GX modifiers). Such modifiers may be used when the provider is uncertain if a claim should be paid (for instance, when the provider does not know if a beneficiary already has had a test that is covered only one per year), or if the beneficiary needs Medicare to deny the claim so it can be submitted to the beneficiary’s secondary insurance. Medicare paid about $744 million for Part B claims with G modifiers in 2011. The OIG found vulnerabilities payments for such claims, since Medicare contractors often do not consider the modifiers to indicate that providers expect the services or items to be denied as not reasonable and necessary or not covered by Medicare. The OIG also reports that Medicare paid $4.1 million for claims with inappropriate combinations of G modifiers from 2002 to 2011. The OIG discusses ways CMS and its contractors could address the vulnerabilities presented in this report through automatic claims denials.
The OIG has issued a report entitled “Medicare and Beneficiaries Could Save Millions If Dialysis Payments Were Adjusted for Anemia Management Drug Utilization.” The OIG estimates that if CMS had adjusted the payments for dialysis services to incorporate anemia management drug utilization in 2011 -- rather than use 2007 data reflecting higher utilization -- the Medicare program could have saved $510 million for erythropoiesis-stimulating agents (ESAs) and $19 million for iron supplements. The OIG also identified limitations in the use of ESRD claims data for program oversight, including inaccuracies in the quantities of drugs claimed and the inability to determine the extent of drug waste or overfill usage. The OIG recommends that CMS: (1) adjust the bundled dialysis base rate to capture savings from decreased utilization of ESAs and iron supplements, (2) remind dialysis facilities of the importance of claims accuracy, and (3) develop guidance for recording drug waste and overfill on ESRD claims. CMS concurred with the recommendations.