Category Archives: OIG

Supplemental Special Advisory Bulletin Clarifies OIG Positions on Independent Charity Patient Assistance Programs

Introduction

The OIG has released a Supplemental Special Advisory Bulletin that “reiterates and amplifies” previous OIG Special Advisory Bulletin guidance from 2005. Pharmaceutical manufacturers and Patient Assistance Programs that provide independent, charitable support for patients’ drug expenses (PAPs) should be aware of this supplemental guidance, as the OIG notes that it may modify some previously-issued favorable advisory opinions. Specifically, in this bulletin the OIG expands on its previous guidance regarding disease funds, eligible recipients, and the conduct of donors.

Background

PAPs provide cost-sharing assistance for patients who cannot afford their prescription medications. Continue reading

OIG Proposes New Revisions to Civil Monetary Penalty Regulations

On May 12th, the Office of the Inspector General of the Department of Health and Human Services (OIG) issued a proposed rule which would amend the federal civil monetary penalty (CMP) regulations addressing new CMP authorities created under the Affordable Care Act.  The revised regulations would allow for civil penalties, assessments, and exclusion from Medicare for :

  • Failure to grant OIG timely access to records;
  • ordering or prescribing while excluded;
  • making false statements, omissions, or misrepresentations in an enrollment application;
  • failure to report and return an overpayment; and
  • making or using a false record or statement that is material to a false or fraudulent claim.

Comments on the proposed regulations can be submitted up until July 11, 2014.  The proposed rule and instructions for submitting comments can be viewed here—> Proposed CMP Regulatory Revisions

For more information on the revisions to the CMP regulations, Fraud and Abuse, Compliance, Medicare Program Integrity initiatives or related issues, please feel free to contact Ari Markenson or any member of our health care practice group for a further discussion.

OIG Issues Report on Limited Compliance with Medicare’s Face-to-Face Requirement for Home Health Services

On April 9, 2014, the US Department of Health and Human Services Office of the Inspector General’s (OIG) Office of Evaluation and Inspections (OEI) issued a report (OEI-01-12-00390) entitled “Limited Compliance With Medicare’s Home Health Face to Face Documentation Requirements.”

The Center for Medicare and Medicaid Services (“CMS”) requires physicians to physically see and evaluate patients for home health services. The Patient Protection and Affordable Care Act requires the physicians to document this face-to-face visit as a condition of payment. The face-to-face requirement was implemented to help prevent fraud in home health. The idea is that requiring physicians to document the specifics of a face-to-face visit with a Medicare beneficiary will help prevent fraud by ensuring the physician actually saw and assessed the beneficiary before certifying the patient as eligible for home health services. Continue reading

OIG 2014 Work Plan – Skilled Nursing Facilities

Recently, the Department of Health and Human Services Office of the Inspector General (the “OIG”) released its work plan for 2014. The work plan provides stakeholders in the health care industry with a broad overview of the OIG’s activities in the coming year as they relate to its enforcement priorities and issues it will review and evaluate during the year. This article is one in a series of articles that will outline the OIG’s activities, as discussed in the 2014 work plan, for a specific industry sector – skilled nursing facilities.

For 2014, the OIG’s activities relating to skilled nursing facilities are focused on billing and payments and quality of care. Continue reading