Category Archives: Fraud – Stark

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“Stark” Rules: Navigating Physician Leases and Subleases

Under the Federal Ethics in Patient Referrals Act (more commonly known as “Stark”), if a physician[1] has a financial relationship with an entity, the physician may not refer patients to the entity for medical services payable by Medicare unless the financial relationship complies with the Stark safe harbors.  Thus, entities that lease or sublease space or … Continue Reading

Priority COVID-19 Fraud Enforcement

Although the Office of the Inspector General (“OIG”)  has previously announced that it would exercise discretion with respect to financial arrangements entered into to facilitate and enhance the availability of COVID-19 testing, the attached Memorandum from the Office of Attorney General also indicates enhanced enforcement scrutiny with respect to fraudulent testing.… Continue Reading

Regulatory Sprint to Coordinated Care: New Stark & Anti-Kickback Rules

On October 22, 2019, CMS and OIG (Office of Inspector General) released new proposed rules regarding Stark Law Exceptions and Anti-Kickback Safe Harbors in response to what has universally been christened as the “Regulatory Sprint to Coordinated Care”, first announced by HHS in June of 2018. As background, please remember that, although the Anti-Kickback Safe … Continue Reading

Western Pennsylvania Hospital Stark/Whistleblower/False Claims Case Provides Real World Guidance For Medical Directors’ Contracts

Emanuele v. Medicor Associates, was presented to the United States District Court for the Western District of Pennsylvania as cross motions for summary judgment, and provides some guidance regarding the Stark requirements for bona fide personal service contracting arrangements. The case originated as a whistleblower allegation that Hamot Hospital had not complied with all of … Continue Reading

OIG Posts Advisory Opinion on Free Transportation Program

On October 21, 2015 the Department of Health and Human Services Office of Inspector General posted Advisory Opinion No. 15-13.  This Opinion relates to a request for Advisory Opinion about a plan to offer free van shuttle services to certain medical facilities in an integrated health system.  The Office of Inspector General (the “OIG”) concluded … Continue Reading

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