Tag Archives: compliance

Physician Hospitalist Group Settles with OCR and Enters Into a Resolution Agreement for Failure to Have HIPAA Policies and Business Associate Agreement in Place

By Paulette Thomas on Posted in Medical Privacy
On Dec. 5, 2018, the Office for Civil Rights (OCR) of the U. S. Department of Health and Human Services (HHS) announced that Advanced Care Hospitalists PL (ACH) had entered into a $500,000 settlement and resolution agreement (RA) resulting from OCR’s investigation of ACH’s breach notification on April 11, 2014, and subsequent supplemental notification. On … Continue Reading

Physicians in the Bulls-eye

Photo of Robert M. WolinBy Robert M. Wolin on Posted in Uncategorized
Several recently reported cases highlight the growing risk physicians face if they succumb to competitive pressures, especially offers of remuneration from labs, pharmacies, home health agencies and other providers to whom they refer. In many cases, the effort to recoup fees may come years after the physician received and spent the fees, with no insurance … Continue Reading

Florida Emergency Power Plan Rule Requires Nursing Homes and Assisted Living Facilities to Obtain Generators

Photo of Jessica Captain NovickPhoto of Maureen FurinoBy Jessica Captain Novick and Maureen Furino on Posted in Uncategorized
The deadline is November 15, 2017 In response to the death of eight nursing home residents after a power failure in Hollywood, Florida during Hurricane Irma, Florida regulators recently issued emergency rules requiring the state’s nursing homes and assisted living facilities to have and maintain backup generators and alternate fuel for power emergencies. However, due to … Continue Reading

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

Photo of Kevin BradberryBy Kevin Bradberry on Posted in Uncategorized
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

By Paulette Thomas on Posted in Uncategorized
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

By Banee Pachuca and Darby C. Allen on Posted in Uncategorized
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

Photo of Robert M. WolinBy Robert M. Wolin on Posted in Uncategorized
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”

By John W. Petrelli and B. Scott McBride on Posted in Uncategorized
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

Photo of Lynn SessionsBy Lynn Sessions and Suchismita Pahi on Posted in Uncategorized
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

By Suchismita Pahi on Posted in Uncategorized
“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

Photo of W. Barron A. AveryBy W. Barron A. Avery, B. Scott McBride and John W. Petrelli on Posted in Uncategorized
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

Photo of Joel D. GottesmanBy Joel D. Gottesman on Posted in Uncategorized
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

Caution: False Claims Act Penalties Poised to Double

By Darby C. Allen and B. Scott McBride on Posted in Uncategorized
A preview of the effects that a provision in the Bipartisan Budget Act of 2015 will have on healthcare providers came to light this week when the Railroad Retirement Board (Board) published an interim final rule implementing the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Act). The Act requires federal agencies to … Continue Reading

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

By B. Scott McBride and John W. Petrelli on Posted in Uncategorized
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

By Paulette Thomas on Posted in Uncategorized
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

Photo of Lynn SessionsBy Lynn Sessions and Suchismita Pahi on Posted in Uncategorized
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

By B. Scott McBride and Darby C. Allen on Posted in Uncategorized
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

By Suchismita Pahi on Posted in Uncategorized
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

By B. Scott McBride and Darby C. Allen on Posted in Uncategorized
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

By B. Scott McBride and John W. Petrelli on Posted in Uncategorized
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

Photo of Robert M. WolinBy Robert M. Wolin on Posted in Uncategorized
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

Photo of BakerHostetlerBy BakerHostetler on Posted in Uncategorized
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

Photo of Kristen McDermott WoodrumBy Kristen McDermott Woodrum, Darby C. Allen and Donna S. Clark on Posted in Uncategorized
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
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