Fraud and Abuse

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Is CMS Prepared for Evolving Medical Records Technology?

Health care fraud accounts for billions of the US health expenditure each year. This week HHS published a study addressing possible deficiencies in CMS’ capability to address fraud vulnerabilities and ensure the integrity of electronic health records (“EHR”) systems which CMS and its contractors use to pay Medicare claims. Concerns about whether CMS’ oversight and … Continue Reading

CMS and OIG Ring in the New Year with Final Rules on EHR Donations

On December 27, 2013, the Centers for Medicare and Medicaid Services (“CMS”) and the Office of Inspector General of the Department of Health and Human Services (“OIG”) published final rules (“Final Rules”) regarding the electronic health records (“EHR”) donations Stark Law Exception (42 C.F.R. 411.357(w)) and Anti-Kickback Statute Safe Harbor (“AKS Safe Harbor”) (42 C.F.R. … Continue Reading

Fourth Circuit Requires Penalties for FCA Violations, Even Where No Government Economic Damage Found

Author: Rebecca A. Worthington, Esquire In a decision sure to generate comment during the new year, the Fourth Circuit ruled in United States ex rel. Bunk v. Gosselin World Wide Moving, No. 12-1369, 2013 U.S. App. LEXIS 25225 (Dec. 19, 2013), that penalties of some amount must be awarded for violations of the civil False … Continue Reading

OIG Okays a Premium Assistance Program

Recently, many stakeholders in the healthcare industry have expressed interest in implementing programs that provide funding to help patients with insurance premium payments.  Until last week, it was unclear whether any type of premium assistance programs would be permissible under federal law.  Finally, in Office of Inspector General (OIG) Advisory Opinion 13-19 posted on December … Continue Reading

District Court Deals Major Blow to Halifax in Bank Busting Qui Tam Suit

On November 13, U.S. District Court Judge Gregory A. Presnell of the Middle District of Florida partially granted the U.S. government’s summary judgment motion against Halifax Hospital Medical Center (“Halifax”).  Judge Presnell ruled that Halifax failed to demonstrate that bonus compensation arrangements it made with medical oncologists satisfied a Stark Law exception.  Judge Presnell found … Continue Reading

Government Finds More Medical Services Unnecessary

In the September 2013 edition of the Cleveland Bar Journal, Colin Jennings and Tom Zeno described the government’s determination to challenge medical decision making as medically not necessary.   To read the article, visit Uncle Sam Becomes a Doctor:  Government Challenges to Medical Necessity. Recent prosecutions have been born out of their prediction. In October 2013, … Continue Reading

Tuomey Ordered to Pay $237 Million

Capping a case that has drawn the attention of healthcare lawyers and hospital executives nationwide, the U.S. District Court for the District of South Carolina has ordered Tuomey Healthcare System, Inc. (“Tuomey”) to pay over $237* million for violations of the Stark Law and False Claims Act arising from certain employment agreements between Tuomey and … Continue Reading

South Carolina AG: Tuomey not Permitted to Indemnify Trustees or Officers

The hits just keep coming for Tuomey Healthcare System, Inc. (“Tuomey”).  Tuomey is not permitted to indemnify its trustees or officers according to an opinion published by the Attorney General of South Carolina (“SC AG”) on September 3, 2013.  In May, 2013, the government requested approximately $237 million in damages after a jury found Tuomey … Continue Reading

Whistleblowers Can Be Anyone – Even Consultants

At first glance, Shands Healthcare’s (“Shands”) agreement to pay $26 million to the federal government and the State of Florida appears to be like all the other recently reported health care fraud settlements of whistleblower complaints. Upon closer inspection however, one significant difference stands out: the relator who initially brought the case against Shands was … Continue Reading

Non-Medicare Patients Only? Not Necessarily an Excuse. New OIG Opinion Shows Government Skepticism of “Carve-Out” Arrangements

Yesterday, the U.S. Dept. of Health and Human Services Office of Inspector General (“OIG”) clarified its stance on a growing practice – provider attempts to circumvent fraud and abuse laws by structuring financial arrangements to apply only to business concerning non-Federal program beneficiaries.  The OIG reiterated its dim view of this practice, citing an underlying … Continue Reading

DC District Court Grants CMS’ Motion to Dismiss Challenge to Regulations Expanding Limitations on Physician-Hospital Joint Venture Under Arrangements

On May 24, in Council for Urological Interests v. Sebelius et al., the United States District Court for the District of Columbia granted CMS’ motion to dismiss a challenge to 2008 regulations promulgated by CMS that: expanded the definition of an entity furnishing designated health services (“DHS”) to mean not only the billing organization but … Continue Reading

In Case You Were Wondering, CMS Takes Compliance Seriously: Lessons from a Medicare Part D Plan Sponsor’s Contract Termination for all Medicare Contractors and Providers

The Centers for Medicare and Medicaid Services (“CMS”) has historically used its authority to immediately terminate Part D plan sponsors only sparingly.  In fact, it has done so only once.  However, when it chooses to exercise this authority, plan sponsors should not count on courts to come to their aid.  In Fox Insurance Co., Inc. … Continue Reading

President’s Budget Proposes Limits on Physician Self-Referral for Certain Services

On April 10, 2013, President Obama released his proposed federal budget for fiscal year 2014.  Buried within the budget is a proposal to limit physician self-referrals for certain ancillary services.  Specifically, the budget proposes to encourage what it calls “more appropriate” use of ancillary services by limiting those providers who may self-refer for radiation therapy, … Continue Reading

Sixth Circuit Overturns $11.1 Million Judgment Against MedQuest for FCA Violations

On April 1, 2013, the United States Court of Appeals for the Sixth Circuit overturned the $11.1 million judgment against MedQuest for its submission of claims to Medicare for tests in diagnostic testing facilities that were not supervised by approved physicians.  The whistleblower action was initiated by a former MedQuest employee, alleging that MedQuest, a … Continue Reading

Proposed Rules Issued Extending Protections of Electronic Health Record Donations

Proposed Rules Issued Extending Protections of Electronic Health Record Donations On April 10, 2013, the Department of Health and Human Services (DHHS), Office of Inspector General (OIG) and the DHHS, Centers for Medicare & Medicaid Services (CMS) each issued a proposed rule relating to the donation of interoperable electronic health records software or information technology … Continue Reading

OIG Issues Special Fraud Alert: Physician-Owned Distributorships (PODs)

OIG Issues Special Fraud Alert: Physician-Owned Distributorships (PODs) On March 26, 2013 the Department of Health and Human Services, Office of Inspector General (OIG) issued a Special Fraud Alert: Physician-Owned Entities (Alert).  The Alert focuses on the specific attributes and practices of “physician-owned entities that derive revenue from selling, or arranging for the sale of, … Continue Reading

Article Shines Spotlight on Pharma Payments to Physicians

An article published today in the Columbus Dispatch shines a spotlight on physicians receiving payments from pharmaceutical companies for speaking and consulting engagements.  The article identifies several central Ohio physicians who have received hundreds of thousands of dollars in fees from drug companies from 2009 through 2012.  The Dispatch’s analysis, taken from data gathered by … Continue Reading

Protecting the Attorney-Client Privilege for In-House Counsel

The interplay between attorney-client privilege and in-house counsel communications has been on many people’s minds since the Middle District of Florida’s decision late last year in US ex rel. Baklid-Kunz v. Halifax Hospital Med. Ctr.  In that case, the court rejected a hospital’s privilege arguments and required production of hundreds of its in-house counsel and compliance officer’s emails … Continue Reading

$762 Million Settlement by Amgen of Civil, Criminal, and Kickback Claims Approved by Judge

Yesterday, Amgen received approval of a global settlement from the federal judge in New York presiding over the criminal case filed against Amgen by the Department of Justice regarding the off-label promotion of the anemia drug Aranesp. The settlement resolves criminal charges and civil kickback claims filed by the federal government, claims of Medicaid fraud filed by 49 states … Continue Reading

Upcoming Webinar "Addressing Enterprise Risk After the Affordable Care Act"

On Thursday, November 15, 2012 at 12:00 Eastern, Squire Sanders, in conjunction with Southwind and Willis Group’s Health Care Practice, will be presenting a free 1-hour webinar on “Addressing Enterprise Risk After the Affordable Care Act” as part of our on-going What Keeps You Up at Night series.  View the event webpage for more information or to … Continue Reading

Massachusetts provider settles HIPAA case for $1.5 million

On September 17, 2012, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced that the Massachusetts Eye and Ear Infirmary and Massachusetts Eye and Ear Associates Inc. (collectively referred to as “MEEI”) agreed to pay $1.5 million to settle potential violations of the Health Insurance Portability and Accountability Act … Continue Reading

A Scary Investigation Ends Well

Shortly before Halloween of last year, a Squire Sanders healthcare client received an omen that all was not well – a Civil Investigative Demand (“CID”) served by the United States Department of Justice (DOJ).  Broad, aggressive, and without identifying any pending legal complaint (CIDs usually don’t), the CID made a frighteningly lengthy list of demands … Continue Reading

OIG Solicits Comments Regarding Revision to Self-Disclosure Protocol

On June 18, the OIG published notice in the Federal Register advising that it is now soliciting information and recommendations for revising its provider self-disclosure protocol. [] The OIG’s self-disclosure protocol is a mechanism whereby providers may voluntarily disclose self-discovered evidence of potential violations of the Anti-Kickback Statute.  Providers utilizing the protocol must disclose a … Continue Reading

GAO Recommends Changing Medicaid Audit Program Due To Poor Results

It appears that the National Medicaid Audit Program hasn’t been worth the money it cost to run.  According to published testimony released by the Government Accountability Office (GAO) today, only 4% of the 1,550 audits, though, resulted in refunds to the government of approximately $7.4 million.  More than two-thirds of the audits found no overpayments.  The remaining 27% … Continue Reading