Category Archives: Fraud – Stark

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District Court Approves Government’s Use of Sampling and Extrapolation to Prove False Claims Act Liability

In United States ex rel. Martin et al. v. Life Care Centers of American, Inc., the Court held that the government could extrapolate from a random sample in order to impose False Claims Act (FCA) liability against Life Care Centers of American Inc. (Life Care) for a substantially larger universe of claims. In order to … Continue Reading

OIG KO’s PODs: Physician Owned Distributorships

The OIG has issued a Special Fraud Alert, dated March 26, 2013, describing specific attributes and practices of Physician Owned Distributorships (PODs) believed to produce substantial fraud and abuse risk and pose dangers to patient safety. PODs are physician owned entities that derive revenue from selling or arranging for the sale of implantable medical devices … Continue Reading

OIG Suspicious of Marketing Arrangements

In OIG Advisory Opinion No. 11-17, the OIG has broadcast its suspicion of percentage based marketing arrangements. The request seeks the OIG’s “no action” letter on a proposal by which a company will provide consulting and marketing services to physician practices. The services would be designed to review patients’ files and identify opportunities to provide allergy … Continue Reading

Ohio Valley Medical Center Signs Corporate Integrity Agreement

Ohio Valley Health Services & Education Corporation, Ohio Valley Medical Center and East Ohio Regional Hospital have collectively entered into a corporate Integrity Agreement with the OIG in September 2011, which focuses on what are defined as “focus arrangements,” which is defined as every financial arrangement between the hospital system and physicians covered by the … Continue Reading

Fifth Circuit Clarifies Qui Tam Public Disclosure Bar

  The Qui Tam process is designed to encourage and Whistleblowers or “relaters” to disclose illegal billing arrangements by paying a percentage of any recovery to the relaters for providing “confidential” information. The theory is that these individuals will be providing information with would not otherwise become available. A corollary to this theory is that relaters cannot … Continue Reading

U.S. ex rel. Singh v. Bradford Regional Medical Center

The USDC for the Western District of Pennsylvania has issued a significant False Claims Act Whistleblower Opinion in the case of U.S. ex rel. Singh v. Bradford Regional Medical Center. The False Claims Act case rested on a lease arrangement between certain physicians and Bradford Regional Medical Center, which the court ruled violated the Stark Act … Continue Reading

OIG Approves “Under Arrangements” Sleep Services

In OIG Advisory Opinion No. 10-24, a sleep testing entity with no physician ownership proposes to provide sleep disorder diagnostic testing and related services to a hospital as “under arrangements” contract, in which the hospital would bill for the services as a hospital outpatient service. The Requester would provide the sleep testing equipment, the sleep testing … Continue Reading

Stark Imaging Self Disclosure Rules

The 2011 Medicare Physician Fee Schedule adds an additional requirement to the in-office ancillary services exception of the Stark Rules. New Section 411.355(b)(7) requires that providers of MRI, CT and PET services must provide a written notice to the patient at the time of the referral, advising that the patient may receive the same services from … Continue Reading

CMS Proposes New Fraud and Abuse Rules

The Centers for Medicare and Medicaid Services (CMS) has issued new proposed fraud and abuse rules in accordance with requirements of the Affordable Care Act (ACA) — first known as the Patient Protection and Affordable Care Act (PPACA).  Section 6501(a) of ACA added Social Security section 1866(j), and required CMS to establish screening procedures for … Continue Reading

CMS Issues: Stark Voluntary Self-Referral Disclosure Protocol

Section 6409 of the Patient Protection and Affordable Care Act (PPACA) required CMS to develop a Medicare Self-Referral Disclosure Protocol (SRDP) to facilitate the resolution of potential Stark violations. The SRDP was published on September 23, 2010 with two caveats: 1.         Despite the fact that potential violations or situations might violate more than just the Stark … Continue Reading

CMS Announces New Stark Self-Referral Disclosure Protocol

  New – Medicare Self-Referral Disclosure Protocol CMS has published the self referral disclosre protocol required by ACA. Link and announcement below. Analysis will be posted next week. Section 6409(a) of the Affordable Care Act (ACA) ACA requires the Secretary of the Department of Health and Human Services, in cooperation with the Inspector General of … Continue Reading

OIG Approves “Per Click” Sleep Venture

 In OIG Advisory Opinion No. 10-14, the OIG concluded that it would not seek enforcement of the Anti-Kickback Statutes under an arrangement in which an independent sleep testing provider entered into an arrangement to provide a hospital-owned sleep testing facility with equipment and staff on a per test basis.… Continue Reading

CMS Position on Whole Hospital Physician Ownership Stark Exception

  Physician Self-Referral CMS proposes to implement changes enacted in ACA to the "whole hospital" and "rural provider" exceptions in the physician self-referral law that will prohibit their use by new physician-owned hospitals and limit the ability of existing physician-owned hospitals to expand their capacity. The deadline for physician investment and having a provider agreement … Continue Reading

Kosenske Whistleblower Case Will Present False Claims Act Issues to Jury

The United States District in Kosenske v. Carlisle HMA Inc. has concluded that this whistleblower case must go to trial on the factual issue of whether Carlisle Hospital violated the False Claims Act by submitting claims for anesthesia services provided arising from referrals from Blue Mountain Anesthesia Associates (BMAA). Dr. Kosenske, the whistleblower in this case, … Continue Reading

PPACA STARK In Office Ancillary Service (IOAS) Disclosure Requirement

Section 6003 of the Patient Protection and Affordable Care Act (PPACA), which is the 2010 Healthcare Reform Act, imposes a new disclosure requirement for in office ancillary service referrals of imaging services.  Section 6003 requires that referrals of MRI, CT, PET, and other designated health services as specified by the secretary, must be accompanied by … Continue Reading

Stark Lease Violations Generate $1.5 in False Claim Penalties for Rush Medical

  This is a Stark settlement that will send chills down the spines of hospital compliance officers. Rush Medical Center has entered into a Settlement Agreement with the DOJ, in which they agree to pay approximately $1.5 in False Claims Act Penalties. The settlement arose out of a qui tam (whistleblower) lawsuit filed in July 2004. The … Continue Reading

October 1, 2009: Effective Date of New Stark Rules

This is just a reminder of the effective date for certain new Stark Rules: 1.         CMS prohibits percentage formulae conjunction with space on equipment leases, fair market value exception transactions and indirect compensation effective October 1, 2009. 2.         Per click leases are prohibited effective October 1, 2009. 3.         "Under arrangement" relationships have been changed because … Continue Reading

Covenant Medical Center to Pay U.S. $4.5 Million to Resolve False Claims Act and Stark Law Allegations

The U.S. Department of Justice issued a press release on August 25, 2009 announcing a $4.5 million False Claims Act Settlement against an Iowa hospital, Covenant Medical Center. The False Claims Act liability allegations were based upon charges by the Attorney General that paying excessive compensation violated the Stark Law. Based upon IRS 990 forms, the … Continue Reading

OIG Advisory Opinion 09-05 Approves Physician On Call Compensation

The Office of Inspector General of the Department of Health and Human Services has issued Advisory Opinion No. 09-05, which states that the OIG will not impose sanctions regarding a proposed on call arrangement in which the hospital will compensate physicians for providing on call coverage for patients presenting to the hospital or emergency department. The … Continue Reading
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