C&M Health Law

C&M Health Law

Analysis, commentary, and the latest developments in health care law and policy

Category Archives: Fraud, Waste & Abuse

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OIG Issues Advisory Opinion Rejecting the Labeling of Test Tubes at No Cost

Posted in Fraud, Waste & Abuse, Medicare
On November 28, 2016, the U.S. Department of Health and Human Services Office of the Inspector General (OIG) issued an unfavorable advisory opinion (No. 16-12) that addresses the permissibility, under the federal Anti-Kickback Statute (AKS), of a laboratory’s proposal to label test tubes and collect specimen containers at no cost to, and for the benefit… Continue Reading

CMS Publishes Interim Final Rule to Address Third-Party Payment of Insurance Premiums by Medicare-certified Dialysis Providers

Posted in Exchanges, Fraud, Waste & Abuse, Health Care Reform & ACA, Medicaid, Medicare
On December 14, 2016, CMS issued an interim final rule with comment period to amend Medicare’s dialysis facility conditions for coverage to require certain disclosures to patients and health insurance issuers to address widespread concerns over inappropriate steerage of dialysis patients to individual market plans. After issuing an RFI about “inappropriate steering of people eligible… Continue Reading

Mount Sinai Health System to Pay $2.95 Million in 60-Day Overpayment FCA Settlement

Posted in Fraud, Waste & Abuse, Health Care Reform & ACA, Litigation
On August 24, 2016, Judge Edgardo Ramos of the Southern District of New York approved a settlement in which Mount Sinai Health System (Mount Sinai) will pay $2.95 million to New York and the federal government to resolve allegations that it violated the False Claims Act (FCA) by withholding Medicare and Medicaid overpayments in contravention… Continue Reading

CMS Renews Focus on Third-Party Payment of Insurance Premiums Steering Medicaid & Medicare Eligibles into Marketplace Plans

Posted in Exchanges, Fraud, Waste & Abuse, Health Care Reform & ACA, Medicaid, Medicare
On August 18, 2016, CMS issued a request for information on “inappropriate steering of people eligible for Medicare or Medicaid into Marketplace plans” by third parties. CMS voiced concern over “anecdotal reports” that Medicaid or Medicare eligibles received premium and cost-sharing assistance from third parties so they could enroll in Marketplace plans, enabling providers to… Continue Reading

Medicaid Managed Care Final Rule: Prevention of Fraud, Waste, and Abuse

Posted in Fraud, Waste & Abuse, Medicaid
The Medicaid Managed Care Final Rule aims to align Medicaid regulations with those of other health coverage programs, modernizing the post-Affordable Care Act healthcare landscape. Among other goals, the Final Rule seeks to bolster the transparency, accountability, and integrity of Medicaid managed care by imposing and clarifying requirements meant to reduce fraud, waste, and abuse.… Continue Reading

Senate Finance Committee Members Hear from Partner Troy Barsky and Hospital System Executives on Necessary Stark Law Reforms

Posted in Fraud, Waste & Abuse, Health Care Reform & ACA, Medicaid, Medicare
Yesterday, our colleague Troy A. Barsky testified before the U.S. Senate Finance Committee led by Chairman Orrin Hatch (R-Utah) and provided recommendations for modernizing the Stark Law to regulate self-referrals without impeding the care coordination and value-based payment models promoted by health care reform legislation. Other witnesses before the Committee included Dr. Ronald A. Paulus,… Continue Reading

New Payment Models and Data: Changes and Themes to Watch

Posted in Events, Fraud, Waste & Abuse, Health IT, Medicare
On June 23, Crowell & Moring and Accenture co-hosted the Fostering Innovative Digital Health Strategies Conference in Crowell’s D.C. office. The conference provided a broad analysis of the business and legal issues that must be addressed as health care organizations and technology companies consider innovative strategies to use digital health technologies. The conference covered several… Continue Reading

In Advance of Senate Finance Committee Hearing on Stark Law Next Week, the Committee Releases Stark Law White Paper

Posted in Events, Fraud, Waste & Abuse, Medicaid, Medicare
On Tuesday July 12, 2016, the Senate Finance Committee (“Committee”) will hold a hearing on “Examining the Stark Law: Current Issues and Opportunities.” Crowell & Moring Partner Troy Barsky will be testifying before the Committee as a Stark Law subject matter authority. In advance of this hearing, the Committee released last week the white paper… Continue Reading

OIG Issues a Favorable Opinion Regarding a Drug Savings Card Program

Posted in Fraud, Waste & Abuse, Medicare
On June 27, 2016, the Department of Health and Human Services Office of Inspector General (“OIG”) issued a favorable Advisory Opinion, No. 16-07, relating to a savings card program under which individuals who have prescription drug coverage under Medicare Part D receive discounts on a drug that is statutorily excluded from Part D coverage. According… Continue Reading

Supreme Court Recognizes FCA Exposure Based on Implied Certification Theory

Posted in Fraud, Waste & Abuse, Government Contracts
In a unanimous decision last week that impacts healthcare providers, vendors and health plans that receive Medicare and Medicaid reimbursements or contract with federal health care programs, the United States Supreme Court in Universal Health Services v. United States ex rel. Escobar held that a defendant may be liable under the implied certification theory under… Continue Reading

Medicaid Managed Care Final Rule: Regulatory Convergence in a Post-ACA World, Novelty, and Modernizing Medicaid Managed Care

Posted in Fraud, Waste & Abuse, Medicaid, Medical Loss Ratios
On May 6, 2016, CMS published the Medicaid managed care final rule in the Federal Register. The Final Rule overhauls Medicaid managed care for the first time in 14 years and tracks many of the industry-wide developments that followed enactment of the ACA. Given the breadth of the rule, Crowell & Moring is covering it… Continue Reading

OIG Updates Policy on Permissive Exclusions Based On Fraud and Kickbacks

Posted in Administrative Law, Fraud, Waste & Abuse, Medicare
The Office of the Inspector General of the Department of Health and Human Services (OIG) last week replaced a 20-year old policy statement, and issued guidance on the criteria the agency will use to evaluate whether to exclude certain individuals and entities from billing or “participation in” Federal health programs under its permissive exclusion authority.… Continue Reading

C&M Alert on the “Overdue” 60-Day Overpayment Rule for Part A & B Providers

Posted in Fraud, Waste & Abuse
Our Health Care Group attorneys have authored a new alert explaining the implications of the final rule on the reporting and return of overpayments (the “Overpayment Rule”) the Centers for Medicare & Medicaid Services (CMS) issued earlier this month.  CMS promulgated the Overpayment Rule nearly two years after the agency issued its final rules governing… Continue Reading

$9.9 Million Settlement To Resolve Allegations That Hospital System Overpaid Physicians Approved by Georgia Federal Court

Posted in Fraud, Waste & Abuse
On February 8, 2016, the United States District Court in the Southern District of Georgia approved the settlement agreement ending a whistleblower lawsuit initiated on March 9, 2011 against Memorial Health University Medical Center (“Memorial Medical Center”) and three affiliated entities in a case that highlights the Department of Justice’s (“DOJ”) vigorous scrutiny of physician… Continue Reading

Congress Introduces Bipartisan Bill to Expand Telehealth, Remote Patient Monitoring

Posted in Fraud, Waste & Abuse, Health IT, Medicaid, Medicare
Last week, Democrats and Republicans from both chambers introduced the Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act (S. 2484, H.R. 4442), which would improve health care quality and realize cost savings by eliminating current restrictions on telehealth and remote patient monitoring. Click here to read our detailed analysis of… Continue Reading

Supreme Court To Take Up Implied Certification Theory of FCA Liability

Posted in Fraud, Waste & Abuse, Health Care Reform & ACA, Litigation
Last week, in a case that will have a significant impact on future False Claims Act (FCA) suits against health care entities, the Supreme Court granted certiorari in Universal Health Services, Inc. v. United States ex rel. Escobar.  By agreeing to hear the case, the Court will resolve the circuit split over the so-called “implied… Continue Reading

CMS Issues Comprehensive Care for Joint Replacement (CJR) Model Final Rule

Posted in Fraud, Waste & Abuse, Medicare
On November 16, 2016, CMS posted the final rule to implement the Comprehensive Care for Joint Replacement (CJR) model, which is a new Medicare payment model intended to hold acute care hospitals financially accountable for the quality and cost of a CJR episode of care and incentivize increased coordination of care among hospitals, physicians, and… Continue Reading

South Florida Hospital System Settles Stark Allegations for $69.5 Million

Posted in Fraud, Waste & Abuse
On September 15, 2015, the U.S. Department of Justice (DOJ) announced the settlement of a qui tam action in the amount of $69.5 million with North Broward Hospital District (NBHD). The amount is a small fraction of the $442 million in treble damages to the Medicare and Medicaid programs alleged in the Third Amended Complaint.… Continue Reading

Health Information Blocking Leads to New Requirements and May Lead to Enforcement Actions

Posted in Fraud, Waste & Abuse, Health IT
The federal government has spent billions to promote adoption and “meaningful use” of health information technology (HIT). There is growing government interest in ensuring that HIT is used to support patient care, but doing so requires electronic exchange of information. Congress, the Department of Health and Human Services (HHS), and States have taken action to… Continue Reading

CMS Releases CY2016 Readiness Checklist

Posted in Fraud, Waste & Abuse, Medicare
CMS released the CY2016 Readiness Checklist, which highlights key compliance areas that Medicare Advantage organizations and Part D sponsors should be particularly mindful as they prepare for the 2016 contract year. The CY2016 Checklist includes new and modified requirements for CY2016 as well as other areas of CMS concern. CMS reminds organizations that, if they… Continue Reading

Health Care System Receives Favorable Advisory Opinion for Free Transportation Services

Posted in Fraud, Waste & Abuse
HHS-OIG published a new favorable advisory opinion on October 21, 2015 regarding free transportation services offered by an integrated health care system.  Integrated health care systems continually seek ways to provide seamless, connected care to patients who may be using multiple providers for treatment of medical conditions. Free transportation is a potential way to ensure… Continue Reading

DOJ’s Memo on Individual Accountability Tears at the Corporate Veil

Posted in Fraud, Waste & Abuse, Litigation
The Department of Justice (DOJ) has further focused its sights on individual executives as responsible parties for corporate misconduct.  On September 9, 2015, Deputy Attorney General Sally Quillian Yates issued a strongly worded seven-page memorandum to all U.S. Attorneys and the Assistant Attorneys General of DOJ’s various divisions nationwide titled “Individual Accountability for Corporate Wrongdoing”… Continue Reading

S.D.N.Y. Provides First Judicial Guidance on Identifying Overpayments and Effect on FCA Liability

Posted in Fraud, Waste & Abuse, Health Care Reform & ACA, Litigation
On August 3, 2015, in Kane v. Healthfirst, Inc., No. 1:11-cv-02325-ER (S.D.N.Y. Aug. 3, 2015), Judge Edgardo Ramos of the Southern District of New York decided an issue of first impression under the False Claims Act (FCA) requirement to return identified overpayments from Medicare and Medicaid within sixty (60) days. In denying the defendants’ motion… Continue Reading