Tag Archives: compliance

Exaggerated Diagnosis Codes and Inadequate Provider Networks: Allegations of Medicare Advantage Fraud Settled for $32.5 Million

The latest settlement involving Medicare Advantage (MA) organizations highlights not only the government’s continuing enforcement focus on Medicare Part C but also the vulnerabilities inherent in that program. In United States ex rel. Sewell v. Freedom Health, Inc. et al., two Florida-based MA organizations – Freedom Health and Optimum HealthCare – agreed to pay $32.5 … Continue Reading

FTC Issues Compliance Guidance for Organizations that Share and Collect PHI

The Federal Trade Commission (FTC) recently issued Guidance to remind HIPAA compliant organizations that share and collect protected health information (PHI) for commercial activities that they must also comply with FTC Act disclosure requirements. The FTC Act prohibits unfair or deceptive acts or practices in or affecting commerce. The Guidance cautions that organizations should consider all disclosure … Continue Reading

Summer Fraud and Abuse Roundup

Now that the kids are back in school and summer vacations are in the rearview mirror, it’s time to catch up on recent fraud and abuse developments. The federal government was busy this summer negotiating a pair of settlements under the Stark Law and anti-kickback statute, drafting changes to the Self-Referral Disclosure Protocol (SRDP), and … Continue Reading

Assault of Home Health Worker by a Patient’s Father Prompts OSHA Violation

A provider of pediatric home health, Epic Health Services, was recently fined $98,000 by the Occupational Safety and Health Administration (OSHA) in connection with the sexual assault of a home health employee by a patient’s father. Allegations include that the father had regularly attempted to grope the employee and made inappropriate comments about her buttocks … Continue Reading

A Tale of Two Escobars: Federal Courts Begin Grappling with Opposing Views of “Materiality”

On June 16, 2016, the U.S. Supreme Court issued a highly anticipated opinion in Universal Health Services, Inc. v. U.S. ex rel. Escobar, which for the first time expressly recognized implied certification as a viable theory under the federal False Claims Act (FCA). Implied certification is a theory that has been widely criticized by government contractors … Continue Reading

$2.75 Million OCR Settlement Underscores the Importance of Risk Management and Analysis

How the theft of a single password-protected laptop turned into an enterprise-wide review of an organization’s data protection practices. Following the announcement of a recent settlement between the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) and Catholic Health Care Services, OCR has announced another significant settlement agreement and corrective action … Continue Reading

Practice Fusion Settles With FTC for Deceptive Practices in Posting Consumer-Generated PHI

“I would like to make an appointment for my back pain and possible shingles. Can you please call me @ [phone number]. Thank you! [patient name]” – Patient Review, December 31, 2012 The Federal Trade Commission (FTC) and cloud-based electronic health record company Practice Fusion, Inc. (Practice Fusion), recently agreed to a proposed settlement to … Continue Reading

No Longer Implied: Supreme Court Expressly Recognizes Implied Certification as a Theory of Liability Under the False Claims Act

Court Rejects the First Circuit’s “Expansive View” of the Theory by Articulating “Rigorous” Standards of Materiality Yesterday, the U.S. Supreme Court issued a long-anticipated decision on the viability of the “implied certification” theory of liability under the False Claims Act (FCA). In Universal Health Services, Inc. v. United States ex rel. Escobar, a unanimous Court … Continue Reading

CMS Announces Final Rule Updating Fire Safety for Healthcare Facilities

The Centers for Medicare and Medicaid Services (CMS) recently published a final rule updating fire safety requirements for healthcare facilities in an effort to increase patient safety and adapt to the needs of an aging population. The new rule adopts provisions of the National Fire Protection Association’s (NFPA) 2012 edition of the Life Safety Code (LSC), as … Continue Reading

Escobar Oral Arguments: Justices Imply Outcome – False Claims Act Implied Certification May Survive

The U.S. Supreme Court recently held oral arguments in the case of Universal Health Services, Inc. v. U.S. ex rel. Escobar, No. 15-7, which is set to decide the viability of implied certification under the FCA. As discussed in our last update on the Escobar case, implied certification is a judicially-created theory under the FCA that establishes liability for a … Continue Reading

OCR Announces Beginning of 2016 HIPAA Phase 2 Audit Program

The OCR recently announced the beginning of the next phase of the HIPAA Privacy, Security, and Breach Notification Audit Program and indicated that it will review the policies and procedures implemented by covered entities and business associates to comply with the HIPAA Privacy, Security, and Breach Notification Rules. During the upcoming months, OCR will contact … Continue Reading

One Week, $5.45 Million in Resolution Agreements for HIPAA Violations

The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) continued its run of resolution agreements for HIPAA violations, pulling in $5.45 million from just two entities, North Memorial Health Care of Minnesota (NMHCM) and theFeinstein Institute for Medical Research (Feinstein), in a single week. The resolution agreements emphasize that business associate agreements and … Continue Reading

The Deeper Dive: The Final Overpayment Rule

The Centers for Medicare and Medicaid Services (CMS) recently issued its final rule for Reporting and Returning of Overpayments (Final Rule). The Final Rule implements section 1128J(d) of the Social Security Act, which requires Medicare providers and suppliers to report and return overpayments within 60 days after the overpayment was identified in most instances. Failure to report … Continue Reading

SAMHSA Proposes Updates to Substance Abuse Records Security and Confidentiality Regulation

The U.S. Department of Health and Human Services’ (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) has released proposed changes to the Confidentiality of Alcohol and Drug Abuse Patient Records regulations (45 C.F.R. Part 2) for the first time since 1987. The proposed changes address challenges that 42 C.F.R. Part 2 programs have faced … Continue Reading

Breaking News: 60-Day Overpayment Rule Finalized

The Centers for Medicare and Medicaid Services (CMS) released its final rule implementing Section 6402(a) of the Affordable Care Act that requires Medicare providers and suppliers to report and return overpayments within 60 days after the date on which the overpayment was identified in most instances. Failure to report and return overpayments in accordance with … Continue Reading

Implied Certification and the FCA: Legally False or a False Legality? The Supreme Court Is Set to Decide

The United States Supreme Court recently granted certiorari in the case of Universal Health Services, Inc. v. U.S. ex rel. Escobar, No. 15-7, which places implied certification under the False Claims Act (FCA) squarely in the judicial crosshairs. Implied certification is a frustrating theory of liability for providers and contractors that receive government reimbursement, due to … Continue Reading

The Deeper Dive: Guarding Against Unrealistic Goals and Organizational Pressures That Can Lead to Compliance Failure

When misconduct occurs within an organization, it is often reported and interpreted as an anecdote involving a few rogue employees who are quickly identified and appropriately disciplined. Misconduct derives, at least in part, from the organizational environment, and studies suggest that pressure from management and the board of directors to meet unrealistic business objectives and … Continue Reading

Rosebush and Holmes Author Article on Contract Pharmacies and 340B Compliance in Journal of Health Care Compliance

Partner Lee Rosebush and Associate Lindsay Holmes authored an article published in the November-December 2015 issue of the Journal of Health Care Compliance. The article, “340B Compliance Issues: Contracting with Contract Pharmacies,” analyzes the compliance issues associated with the use of contract pharmacies by a covered entity in the 340B setting. Rosebush and Holmes emphasize that such covered entities must … Continue Reading

CMS Finalizes Revisions to Stark to Ease Burden on Providers, Refines “Incident to” Requirements

In its calendar year 2016 Physician Fee Schedule Final Rule published in the Federal Register on November 16, 2015 (Final Rule), the Centers for Medicare and Medicaid Services (CMS) finalized amendments to the federal physician self-referral (Stark) regulations proposed in the Physician Fee Schedule proposed rule released in July. Among the significant provisions contained in the Final Rule are … 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

D.C. District Court Deals Blow to HHS 340B Program Interpretive Rule

Court says Congress has the power to make the change that HHS attempted with its Interpretive Rule, and thus it should be left to the legislative branch. A lawsuit challenging the Interpretive Rule, filed by the Pharmaceutical Research and Manufacturers of America (PhRMA) in October 2014, was recently vacated in favor of PhRMA by the … Continue Reading
LexBlog