Stark Law

News & Analysis as of

Proposed 2016 Medicare Physician Fee Schedule Includes Changes to Stark Regulations

The Centers for Medicare & Medicaid Services ("CMS") recently released the proposed 2016 Medicare Physician Fee Schedule (the "Proposed Rule"), which includes a number of proposed revisions to the regulations under the...more

Corridors September 2015 - News for North Carolina Hospitals

This article will provide an outline of some of the most significant points for hospitals to use when confronted with a formal government investigation under the Criminal or Civil False Claims Act. As noted below, you should...more

Also In The News - Health Headlines - August 2015 #4

President Obama Signs Outpatient Status Notification Bill On August 6, 2015, President Obama signed the Notice of Observation Treatment and Implication for Care Eligibility (NOTICE) Act. This legislation requires hospitals...more

The Difficulty Of Challenging FCA Fine As Excessive

Last month, in U.S. ex rel. Drakeford v. Tuomey, No. 13-2219, (4th Cir. July 2, 2015), the Fourth Circuit affirmed a False Claims Act verdict against a nonprofit hospital in Sumter, South Carolina. In an area of the law where...more

Healthcare Legal News: Volume 5, Number 3

RESPONDING TO SUBPOENAS AND OTHER REQUESTS FOR PERSONAL HEALTH INFORMATION: TAKE THEM AT FACE VALUE - Healthcare providers and other HIPAA covered entities receive requests for protected health information (“PHI”) from...more

Free Patient Parking May Trigger False Claims Act Violation

Who knew? When you park for free at your doctor’s office, you may be a pawn in a scheme to violate the Anti-Kickback Statute, the Stark Law, and the False Claims Act. It’s enough to make you sick....more

OIG Issues Two Favorable Advisory Opinions

OIG recently issued two favorable advisory opinions. On August 12, 2015, OIG approved a program that provides a free cancer drug approved under the FDA’s Breakthrough Therapy Designation to patients who meet certain criteria...more

CMS Stark Proposals Allow “Holdover” Arrangements and Signature Window

In July 2015, CMS released proposals to provide several new Stark Law exceptions and to clarify issues regarding existing exceptions. The full text of these proposal and CMS comments and explanations is available below....more

Health Law Pulse - August 2015

The Office of the Inspector General (OIG) recently issued a favorable advisory opinion (Advisory Opinion) to a nonprofit health system (System) and a nonprofit psychiatric hospital (Center) regarding a proposal whereby the...more

CMS Clarifies Written Agreement Requirement

CMS has acknowledged that arrangements among providers to satisfy the Stark exceptions need not be created in a single document. Although a single written document memorializing the key facts of an arrangement could provide...more

CMS Proposes New Stark Exceptions: Timeshare Lease

In July 2015, CMS released proposals to provide several new Stark Law exceptions and to clarify issues regarding existing exceptions. Over the next few days, I will post comment on what I consider the most significant new...more

Hospital Chain Pays Heavy Price for Being Too Clever

Finding that Community Hospital Systems had been “too clever by half” in negotiating a global settlement agreement for seven whistleblower suits, a federal judge ordered the chain to pay the attorneys’ fees of all the...more

CMS Proposes New Stark Exception: Recruitment of Non-Physician Practitioners

In July 2015, CMS released proposals to provide several new Stark Law exceptions and to clarify issues regarding existing exceptions. Over the next few days, I will post comments on what I consider the most significant new...more

Providers Wary after First Ruling on 60-Day Rule

The False Claims Act (“FCA”) is already a minefield for healthcare providers, especially when coupled with the Stark Law. Treble damages and fines of up to $11,000 per violation add up quickly under the FCA. The U.S. District...more

CMS Sends a Lifeline on Stark after Tuomey Affirmed: What Health Providers Should Know

In July, the Court of Appeals for the Fourth Circuit upheld a record verdict of $237 million against Tuomey Healthcare Systems in the case of U.S. ex rel. Drakeford v. Tuomey Healthcare System, Inc. for violations of the...more

Corporate Investigations & White Collar Defense - August 2015

Are the Circuits A-Splitting? The Ninth Circuit Declines to Follow the Second Circuit's Insider Trading Decision in U.S. v. Newman - Why it matters: On July 6, 2015, the Ninth Circuit in U.S. v. Salman declined to...more

CMS Proposes Amendments to Stark Law

On July 15, 2015, the Centers for Medicare & Medicaid Services (“CMS”) published proposed regulations governing policies and payments made under the 2016 Physician Fee Schedule (the Proposed Rule). Notably, the Proposed Rule...more

CMS Proposed Stark Law Revisions

On July 15, 2015, the Centers for Medicare and Medicaid Services (“CMS”) published proposed revisions to the regulations implementing the physician self-referral law, or Stark Law. The Stark Law is a key regulatory...more

The “Cross-Your-Fingers-And-Hope-It-Goes-Away” School of Statutory Interpretation”: Recent D.C. Circuit Opinion Orders HHS To...

On June 12, 2015, the U.S. Court of Appeals for the District of Columbia (the “Court”) issued an opinion questioning the Department of Health & Human Services’ (“HHS”) interpretation of congressional intent when it...more

Physician Compensation Arrangements Under The Microscope

On June 9, 2015, the United States Department of Health and Human Services Office of Inspector General (OIG) issued a Fraud Alert titled, "Physician Compensation Arrangements May Result in Significant Liability," focusing on...more

Recent Stark Developments: A Moving Target Where a Miss is as Good as a Mile

The federal physician self-referral ban or Stark law has been a part of the legal landscape for almost 25 years. The breadth of the law’s prohibitions, its strict liability formulation and draconian remedies have made it the...more

The Implications of CMS' Proposed Stark Law Regulations

On July 8, 2015, the Centers for Medicare & Medicaid Services (“CMS”) released proposed regulations “to reduce burden and to facilitate compliance” under the physician self-referral law known as the Stark Law. See 80 Fed....more

CMS Proposes Stark Law Amendments, Requests Comments on Whether Stark Law Is Barrier to Health Care Reform

On July 8, 2015, the Centers for Medicare & Medicaid Services (CMS) published a notice of proposed rulemaking to amend its regulations implementing and interpreting the Stark Law (the Proposed Rule). 80 Fed. Reg. 41,686,...more

Proposed Rule Aims to Refine Stark Regulations and Clarify “Incident To”

On July 15, 2015, the Centers for Medicare and Medicaid Services (CMS) published the calendar year (CY) 2016 Physician Fee Schedule Proposed Rule. In addition to updating several traditional Part B payment policies, the...more

Potential Stark Changes Ahead

On July 15, 2015, the Centers for Medicare and Medicaid Services (“CMS”) published proposed regulations governing policies and payments made under the Physician Fee Schedule for calendar year 2016 (the “Proposed Rule”). In...more

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