Kusserow on Compliance: OIG’s planned work for home health agencies

Home Health Agencies (HHAs) remain one of the top enforcement priorities for the DOJ and HHS Office of Inspector General (OIG). Considerable OIG investigative resources are devoted to HHA fraud. However, the OIG auditors and evaluators are also focusing on HHA waste and abuse. For example, in May 2019, the OIG released several audit reports related to HHAs, including those for EHS Home Health, Excella Home Care, Great Lakes Home Health, and Metropolitan Jewish Home Care. The OIG found a number of deficiencies, including beneficiaries who were not homebound that were able to ambulate without assistance and perform home exercises, or had only a partial episode (wound healed). In addition, in many cases, documentation was not provided or did not support services. To continue its efforts in this area, the OIG has added several planned audits and evaluations related to HHAs, including the following:

  1. OIG will review supporting documentation to determine whether home health claims with 5 to 10 skilled visits in a payment episode, in which the beneficiary was discharged home, met the conditions for coverage and were adequately supported as required by federal guidance.

 

  1. Recent OIG reports disclosed high error rates at individual HHAs, consisting primarily of beneficiaries who were not homebound or who did not require skilled services. So, the OIG will continue its efforts regarding whether home health claims were paid in accordance with federal requirements.

 

  1. Using data from the CMS’s Comprehensive Error Rate Testing (CERT), the OIG plans to identify the common characteristics of “at risk” HHA providers that could be used to target pre- and post-payment review of claims.

 

  1. The OIG will review Medicare Part A payments to HHAs to determine whether claims billed to Medicare Part B for items and services were allowable and in accord with federal regulations. Generally, certain items, supplies, and services furnished to patients are covered under Part A and should not be separately billable to Part B. the OIG has previously found noncompliance with these Medicare billing requirements.

 

  1. The OIG will compare HHA survey documents to Medicare claims data to look for evidence of patients omitted from HHA-supplied patient information from select recertification surveys using Medicare claims data.

 

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

Connect with Richard Kusserow on LinkedIn.

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Copyright © 2019 Strategic Management Services, LLC. Published with permission.

Annual report to HHS for improving Medicare, Medicaid, and related services

HHS should undertake steps to (1) guard against fraud, waste, and abuse, (2) help beneficiaries and providers, and (3) implement better payment policies, according to the Office of Inspector General’s (OIG) annual report on the top unimplemented recommendations from the previous year. While the report ranged far and wide in its recommendations, including a suggestion to the FDA to improve food safety inspections, the bulk of the report was dedicated to addressing fraud, waste, and abuse in Medicare and Medicaid (OIG Report, July 22, 2019).

Background

Each year, the OIG creates a report that focuses on what it contends are the top recommendations for improvement in HHS programs that were not implemented over the past year. This report offers suggestions to both HHS and the FDA on where they should direct their reform efforts for maximum benefit.

The OIG made the following recommendation pertaining to fraud, waste, and abuse.

Inpatient rehab facilities 

In 2013, Medicare paid $5.7 billion to inpatient rehabilitation facilities (IRF) for care to beneficiaries that was not reasonable and necessary. The errors, the OIG said, were due in part to the fact that the payments to the IRFs were not properly aligned with the costs. The current system gives the IRFs a financial incentive to admit patients inappropriately. CMS is apparently evaluating the payment system, which includes a recently issued final year 2019 IRF prospective payment system final rule to update policies and payment rates for fiscal year 2019.

‘Least costly alternative’ Part B drugs

If the least costly alternative requirement had not been rescinded for Part B drugs, Medicare would have saved $33.3 million in one year ($264.6 to $231.3 million). Once the requirement was removed, utilization patterns shifted dramatically in favor of costlier products.

Part D drug oversight

Medicare Part D spending on compounded topical drugs soared from $13.2 million in 2010 to $232.5 million in 2016. Questionable billing practices seem to be concentrated in a few metropolitan areas. OIG has identified prescribers with troubling order patterns. States are hamstrung in their ability to prevent drug overpayments. State agencies need to know the 340B ceiling prices and which Medicaid claims are associated with 340B drugs to ensure that the claims are paid correctly.

Managed care organization improvements

OIG believes that a significant amount of underreporting of fraud and abuse is occurring in Medicaid involving managed care organizations. For example, even where a managed care organization discovers fraud or abuse, OIG says that it will handle the situation by itself (terminating the contract) rather than report it to CMS. CMS must do more to ensure that the organizations identify and refer fraud and abuse to the state.

Help beneficiaries and providers

In addition, the OIG recommended that CMS analyze the impact of counting time as an outpatient toward the 3-night requirement for skilled nursing facility services (SNF). Beneficiaries with similar post-hospital care needs have different access to SNF services depending upon whether they were outpatients or inpatients because of the requirement that the beneficiary spend at least three nights as an inpatient to obtain post-hospital SNF Medicare coverage. Furthermore, CMS paid an estimated $84.2 million in improper payments between 2013 and 2015 because SNFs incorrectly determined whether the 3-night requirement was met. CMS should consider changes to make the system fairer, which could include counting time as an outpatient.

FDA

The OIG had a single recommendation for the FDA, noting that deficiencies exist in the FDA’s electronic recall data system. The FDA relies too much on voluntary corrections by facilities. Just over half the facilities that were inspected and should have received warning letters actually received warning letters. The FDA also frequently fails to conduct timely follow-up inspections to ensure compliance. The OIG suggested that the FDA act to address these shortcomings.

Kusserow on Compliance: Tips on mergers and acquisitions due diligence

– Failing to engage in regulatory due diligence may result in legal exposure

– Most M&As in health care fail to adequately check regulatory risk liabilities

Tom Herrmann, a former senior executive in the Office of Counsel to the Inspector General (OCIG) and Medicare Appeals Council Appellate Judge, provides interesting insights on this subject as result of his government experience and work with due diligence reviews.  Traditionally, law firms conducting due diligence reviews focus on contracts and other legal obligations. They examine a multitude of areas including an entity’s structure; contractual, intellectual and property obligations; securities and financing compliance; tax exposure risks; and previous and current litigation. Public accounting firms assess the financial accountability and viability of an entity. It is not uncommon for the accounting and law firms to have the scope of their due diligence reviews limited to their areas of expertise, which often do not include health care regulatory compliance. This may result in a failure to adequately review and address potential problems in the regulatory compliance arena. Regulatory due diligence is a specialized review process that requires the application of certain protocols, and protocols and can be performed quickly and efficiently to identify areas of regulatory risk and vulnerability. A review should include assessing the effectiveness of the entity’s compliance program; evaluating internal monitoring of high-risk areas; conducting sample of claims audits and extrapolations; and the ongoing internal audit process of a company. Regulatory compliance experts know where to look for weaknesses without having to do a “deep dive.” Thus, such a review can be performed in an efficient and cost-effective manner. He offers the following tips for those engaged in M&A:

  1. Any party considering an acquisition or entering into a merger should adequately assess potential future government enforcement or regulatory action. This provides an incentive for an acquiring party to require the disclosure prior to a merger or acquisition of any information or documentation relating to a pending or potential government enforcement or regulatory action.

 

  1. The matters disclosed during a regulatory due diligence review may encompass a broad range of issues, including employing or contracting with an excluded party, a flawed arrangement with a physician, or Medicare or Medicaid overpayments.

 

  1. Once a potential legal or regulatory violation is identified, a resolution of the matter, including self disclosure to appropriate government authorities, should be addressed by the parties.

Tom Herrmann may be reached at thermmann@strategicm.com or at (703) 535-1410 for more information on this topic.

 

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

Connect with Richard Kusserow on Google+ or LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

Copyright © 2019 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: New OIG Work Plan items

The HHS Office of Inspector General (OIG) recently issued updates to its Active Work Plan (Work Plan). The Work Plan outlines ongoing and planned audits and evaluations for the fiscal year and beyond. Recent additions related to Medicare/Medicaid include the following:

  1. Medicare Part D Rebates Related to Drugs Dispensed by 340B Pharmacies. Drug manufacturers often do not pay for Medicare Part D prescription rebates filled at 340B-covered entities and contract pharmacies because the manufacturer already provides a discount on the drug. The OIG will conduct a study to determine the potential rebate savings if Part B program sponsors and manufacturers could agree on eligible prescriptions filled at 340B pharmacies that receive rebates.

 

  1. Characteristics of Part D Beneficiaries at Serious Risk of Opioid Misuse or Overdose. An OIG data brief found that about 71,000 Medicare Part D beneficiaries were at serious risk of opioid misuse or overdose in 2017. The OIG will study: (1) the characteristics of these beneficiaries, including their demographics and diagnoses; (2) the opioid utilization of these beneficiaries; and (3) the extent to which these beneficiaries have had adverse health effects related to opioids and any overdose incidents.

 

  1. Ensuring Dual-Eligible Beneficiaries’ Access to Drugs Under Part D: Mandatory Review.

Part D plans that meet certain limitations have the discretion to include different Part D drugs and drug utilization tools in their formularies. Under the Affordable Care Act, the OIG conducts an annual study to review the extent to which Part D sponsors’ formularies include drugs commonly used by Medicaid and Medicare Part D beneficiaries.

 

  1. Nursing Facility Staffing: Reported Levels and CMS Oversight. CMS uses the Payroll Based Journal auditable daily staffing data to analyze staffing patterns and populate the staffing component of the Nursing Home Compare website. It aids the public determine the results of health and safety inspections, quality of care at nursing facilities, and staffing. The OIG will issue two reports to: (1) describe nursing staffing levels that facilities report to the Payroll-Based Journal; and (2) examine CMS efforts to ensure data accuracy and improve resident quality of care.

 

  1. Medicare Part B Payments for Podiatry and Ancillary Services. Medicare Part B covers podiatry services for medically necessary treatment of foot injuries, diseases, or other medical conditions affecting the foot, ankle, or lower leg. It does not cover routine foot-care services unless they are: (1) necessary and integral part of otherwise covered services; (2) for the treatment of warts on the foot; (3) in the presence of a systemic condition or conditions; or (4) for the treatment of infected toenails. The OIG will review Part B payments to determine whether podiatry and ancillary services were medically necessary and supported in accordance with Medicare requirements.

 

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

Connect with Richard Kusserow on Google+ or LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

Copyright © 2019 Strategic Management Services, LLC. Published with permission.