Tag Archives: OIG

Destination Medicine: Not Just for the Rich and Famous

OIG okays providing modest hotel and meal accommodations for rural and financially needy patients. The U.S. Department of Health and Human Services Office of Inspector General (OIG) recently issued an advisory opinion interpreting the finalized rules related to the beneficiary inducement civil monetary penalties (CMP) law. In a previous blog post, we discussed the OIG … Continue Reading

Final Rule Expands OIG Exclusion Authority

On January 12, 2017, less than a week before the official transition from one administration to the next, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a rule finalizing changes to its most potent compliance tool: exclusion authority. The Affordable Care Act (ACA) significantly expanded the OIG’s permissive … Continue Reading

Providers Breathe Sigh of Relief with New Anti-Kickback Safe Harbors and CMP Exceptions

On December 7, 2016, the HHS Office of Inspector General (OIG) finalized a set of rules first proposed in 2014 adding new anti-kickback law safe harbors and protecting additional conduct from enforcement under the civil monetary penalties (CMP) law related to beneficiary inducements. The OIG’s stated purpose in adopting the rule is to allow greater … Continue Reading

Drug Manufacturer Discount Cards: Accept With Caution

Pharmaceutical manufacturer discount card usage by government program beneficiaries has been an active area for government action in recent years.  In a September 2014 Special Advisory Bulletin, the U.S. Department of Health and Human Services, Office of Inspector General (OIG) stated, “[t]hese coupons constitute remuneration offered to consumers to induce the purchase of specific items.” … Continue Reading

Solicitation of New Safe Harbors and Special Fraud Alerts

The U.S. Department of Health and Human Services Office of Inspector General (OIG) recently announced its annual solicitation of proposals and recommendations for developing new, and modifying existing, safe harbor provisions under the federal anti-kickback statute as well as for developing new OIG Special Fraud Alerts. The criteria used by the OIG to determine whether … Continue Reading

Health System Free Transportation Program Does Not Warrant Sanctions, Says OIG

The Office of Inspector General (OIG) recently issued Advisory Opinion 15-13, addressing whether an integrated health system (Health System) was at risk for administrative sanctions under the federal anti-kickback statute or civil monetary penalty law for offering free shuttle services to patients. The OIG concluded that the proposed transportation arrangement presents minimal risk of fraud … Continue Reading

OIG Emphasizes Proactive Enforcement of Privacy Rule and Monitoring of Repeat Offenders

The Office of Inspector General’s (OIG) recently released Privacy Standards report assessed the Office for Civil Rights’ (OCR) oversight of covered entities’ compliance with the Privacy Rule as well as the extent to which Medicare Part B providers are aware of HIPAA privacy standards. To that end, the OIG found that Part B providers fell … Continue Reading

HHS OIG Creates New Taskforce to Pursue Civil Monetary Penalties and Exclusions

If you have any questions concerning this article, please contact: B. Scott McBride at smcbride@bakerlaw.com or 713.646.1390; Greg Saikin at gsaikin@bakerlaw.com or 713.646.1399 from our Healthcare Investigation and Enforcement team; John J. Carney at jcarney@bakerlaw.com or 212.589.4255; George A. Stamboulidis at gstamboulidis@bakerlaw.com or 212.589.4211 from our White Collar Defense and Corporate Investigations team; or Hilary … Continue Reading

OIG Advisory Opinion 15-07: An Indicator of Clinical Trial Copayment Change?

“You scratch my back, I scratch yours” arrangements are common in business transactions. These agreements are risky in the healthcare space, however, with the potential to implicate civil and criminal sanctions. Whether involving a patient, provider, or industry, the government closely scrutinizes quid pro quo arrangements when the government foots the bill. Clinical trial sponsors … Continue Reading

OIG Advisory Opinion Sheds Light on Preventive Care Exception

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently issued an advisory opinion approving an arrangement whereby a licensed entity providing services under a state program for at-risk mothers and children (State Program) would provide diapers and play yards to program participants who are Medicaid beneficiaries. The advisory opinion … Continue Reading

OIG Proposed Anti-Kickback Safe Harbors and CMP Regulations: The End of Frustration or Just the Beginning?

On October 3, 2014, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published an unexpected, yet long-awaited, set of proposed rules that would add new anti-kickback law safe harbors, protect additional conduct from enforcement under the civil monetary penalties (CMP) law related to beneficiary inducements and create a new gainsharing … Continue Reading

OIG Issues Special Advisory Bulletin Covering Manufacturer Copay Coupons and Medicare Part D

For years, many drug manufacturers have issued coupons to help cover some or all of the cost of copayments (commonly referred to as a “copay”) for prescription medications.  While the Department of Health and Human Services (HHS) Office of Inspector General (OIG) has previously provided some guidance on the use of these coupons, there has … Continue Reading

Implications on Pharmacies of Recent OIG Advisory Opinion on Per-Fill Fees

The U.S. Department of Health & Human Services, Office of Inspector General (OIG) recently issued an advisory opinion regarding a proposed arrangement by a specialty pharmacy (Requestor) to pay local pharmacies a per-fill fee for the provision of support services in connection with patient referrals to the specialty pharmacy. OIG found that this per-fill fee … Continue Reading

Compounded Drugs and Medicare Part B: OIG Report Recommends Payment and Oversight Changes

The U.S. Department of Health and Human Services (HHS) Office of the Inspector General (OIG) recently published a report titled “Compounded Drugs Under Medicare Part B: Payment and Oversight” (Report) in which it recommended that the Centers for Medicare & Medicaid Services (CMS) implement changes to the way Medicare Part B claims for compounded drugs … Continue Reading

OIG Revamps Regulations Concerning CMPs and Exclusion

In a pair of proposed rules published in May, the HHS OIG unveiled changes to the regulations concerning OIG’s authority to impose civil monetary penalties (CMPs) and exclude individuals and entities from participation in federal healthcare programs. The changes are largely driven by provisions in the Affordable Care Act (ACA) and illustrate OIG’s expansion of … Continue Reading

Recent OIG Report Underscores Need for Home Health Agencies and Physicians to Comply With Medicare’s Face-to-Face Documentation Requirements

Medicare overpaid the home health industry $2 billion between January 2011 and December 2012, according to a recent report by the U.S. Department of Health and Human Services, Office of Inspector General (OIG). The OIG’s findings are based on a random sample review of claims submitted by home health agencies (HHAs) around the country—in particular, … Continue Reading
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