Tag Archives: Office of Inspector General

New OIG Advisory Opinion Allows Waiver of Cost Sharing in Research Studies

The Office of Inspector General (OIG) recently issued Advisory Opinion 17-02, allowing waivers or reductions of cost-sharing amounts owed by financially needy Medicare beneficiaries in connection with certain clinical research studies conducted at a non-profit medical center.  In the advisory opinion, the OIG reiterated its longstanding concern about routine waivers of Medicare beneficiary cost-sharing amounts in the absence of financial hardship, and noted this can lead to liability under the anti-kickback statute (AKS).  The research studies were conducted utilizing protocols under the Medicare Coverage with Evidence Development (CED) framework …

EHR Vendor Settles False Claims Act Suit for $155 Million

Electronic health record (EHR) vendor eClinicalWorks (eCW) recently entered into a settlement with the US Department of Justice (DOJ) and the Department of Health and Human Services’ Office of Inspector General (OIG) to resolve allegations under the federal False Claims Act (FCA) that eCW misrepresented its software and paid customers kickbacks to promote its products. The settlement imposes joint and several liability for payment on the EHR Vendor and three of its founders for $154.92 million, and liability for settlement payments individually by a developer ($50,000) and two project managers …

OIG Publishes Prioritized Recommendations for HHS

The OIG has released the 2017 Compendium of Unimplemented Recommendations, summarizing prioritized recommendations relating to HHS programs and operations.   Topping the list are recommendations relating to hospitals, including:

  • Reimbursement rates for critical access hospital swing beds should be adjusted to the lower rates for similar services provided in skilled nursing facilities.
  • Reimbursement rates for hospital outpatient department procedures should be adjusted to the lower rates for similar procedures conducted in ambulatory surgical centers.
  • Medicare should adopt a hospital transfer payment policy to lower hospital reimbursement for beneficiaries who are

DOJ Announces $23 Million in Settlements Related to Implantation of ICD Cardiac Devices

On February 17, 2017, the U.S. Department of Justice (DOJ) announced settlements with 51 hospitals related to implantable cardioverter defibrillators (ICD), totaling over $23 million.  Combined with previously announced settlements, the DOJ has now reached agreements with more than 500 hospitals totaling more than $280 million relating to ICDs.   According to the DOJ, most of the 51 settling defendants were named in a False Claims Act qui tam lawsuit filed by a health care reimbursement consultant and a cardiac nurse.  U.S. ex rel. Ford et al. v. Abbott Northwestern

New Anti-Kickback Safe Harbors and Exceptions to CMP Law

On December 7, 2016, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited final rule establishing new Anti-Kickback Statute (AKS) safe harbor protections and codifying regulatory exceptions to the Civil Monetary Penalties Law (CMP).

Local Transportation Safe Harbor

This safe harbor protects local transportation made available by an “Eligible Entity” as long as the following conditions are met.  An “Eligible Entity” is any individual or entity, except for individuals or entities (or family members or others acting on their behalf) that primarily supply health

OIG Issues Favorable Advisory Opinion for Cost-sharing Waivers and Stipends in a Clinical Research Study

On December 13, 2016, the Office of Inspector General (OIG) issued a favorable Advisory Opinion to a university health system (the Requestor) for two arrangements relating to a federally-funded clinical research study designed by a physician-employee (the Study):

  1. a proposal to waive the cost-sharing obligations of Study participants (Participants) for medically necessary health care services received under the Study protocol (the Proposed Arrangement), and
  2. payment of a stipend to Participants for the time and effort required to participate (the Current Arrangement).

OIG Recommends More Monitoring of Hospital Compliance With Two-Midnight Rule

The Office of Inspector General (OIG), Health & Human Services recently released a report detailing its analysis of hospital compliance with the Centers for Medicare & Medicaid (CMS) “two-midnight” rule during fiscal year 2014, which allows Medicare payment for inpatient claims only if the treating physician expects that the patient will require hospital services at least two midnights. The two-midnight policy was implemented by CMS to, in part, reduce inconsistent use of inpatient and outpatient hospital stays and address improper payment for short inpatient stays. The OIG found that hospitals …

OIG Increases Nominal Value for Gifts to Beneficiaries

In a Policy Statement by the Office of Inspector General (OIG), Health & Human Services released December 7, 2016, the OIG updated its long-standing interpretation of the term “nominal value” with regard to gifts to federal health care program beneficiaries that do not comprise “remuneration” under section 1128A(a)(5) of the Social Security Act. The OIG now interprets nominal value as having a retail value of no more than $15 per item and $75 in the aggregate per patient annually, as long as the items are not cash or cash equivalents. …

OIG’s 2016 Report on Provider-Based Facilities

On June 16, 2016, the Office of Inspector General (OIG), Department of Health and Human Services, issued a report on the Centers for Medicare & Medicaid Services’ (CMS) oversight of provider-based facilities.  In the report, the OIG concluded that although CMS is taking steps to improve its oversight, vulnerabilities nevertheless remain.

As part of its Bipartisan Budget Act of 2015, Congress had eliminated provider-based status for new off-campus outpatient departments of a provider. The Centers for Medicare & Medicaid Services’ (CMS) provider-based rules currently allow a hospital or health system …

Fraud And Abuse Waivers For ACOs

On October 29, 2015, the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG), Health & Human Services issued a final rule (Final Rule) regarding waivers (ACO Waivers) of the physician self-referral law (Stark law), the federal Anti-Kickback Statute, and the Civil Monetary Penalties Law (CMP) provision relating to beneficiary inducements for Medicare accountable care organizations (ACOs) participating in the Medicare Shared Savings Program (MSSP). The ACO Waivers waive the application of these fraud and abuse laws to certain ACO activities that are reasonably related …

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