Stark Law

News & Analysis as of

Compliance Reminder — DOJ Announces Largest Healthcare Fraud Takedown

On Wednesday, June 22, 2016, the DOJ announced the largest nationwide heath care fraud takedown in history, which resulted in criminal and civil charges against 301 individuals for alleged participation in health care fraud...more

Free Transportation Gets Another Nod from OIG

On March 1, 2016, the Department of Health and Human Services Office of Inspector General once again issued a favorable advisory opinion for the provision of free transportation by a healthcare facility. In this instance, an...more

CMS Announces Plans to Streamline the Stark Self-Referral Disclosure Protocol

On May 6, 2016, CMS published a notice (Notice), required under the Paperwork Reduction Act (PRA), seeking public comment on its plans to revise the information collected under the Medicare Self-referral Disclosure Protocol...more

Legal Issues Associated with Multi-Provider Alternative Payment Model

Since the passage of the Affordable Care Act (ACA), both federal and state policies have promoted the adoption of alternative payment models (APMs), providing financial incentives for groups of providers to improve care...more

Finance Committee Report Places Medical Device Arrangements under Increasing Scrutiny

Hospitals and providers participating in physician-owned distributorships, or “PODs” may be at increased risk for government investigation or enforcement. A Senate Finance Committee (SFC) Report issued this month highlights...more

Physician-Owned Distributor (POD) Update

For some time, we have been reporting on issues involving federal government scrutiny of physician-owned distributors ("PODs"). From the Department of Health and Human Services Office of Inspector General’s ("OIG") issuance...more

Senate Finance Report Puts another Nail in the POD Coffin

On May 10, 2016, the Senate Finance Committee Majority Staff released a long-awaited report entitled “Physician Owned Distributorships: An Update on Key Issues and Areas of Congressional Concern” (Report). The Report follows...more

CMS Unveils Revised Voluntary Self-Referral Disclosure Protocol

On May 6, 2016, the Centers for Medicare and Medicaid Services (CMS) released proposed revisions to its Voluntary Self-Referral Disclosure Protocol (SRDP), through which providers may disclose actual or potential violations...more

CMS Proposes Extension of Medicare Self-Referral Disclosure Protocol Lookback Period to Six Years

CMS has published a notice inviting comments on a revised Medicare Self-Referral Disclosure Protocol (SRDP), which is a vehicle for providers and suppliers to voluntarily self-disclose actual or potential violations of the...more

New and Disruptive Technologies: The Care and Feeding of the New Economy [Expect Focus – Vol. I, Winter 2016]

IN THE SPOTLIGHT - The CFPB Takes First Enforcement Action Related to Data Security Practices. LIFE INSURANCE - Class Certified in Unique Fixed Indexed Annuity Case. Alleged Misrepresentations to DFS Warrant...more

2016 Stark Law Updates

Centers for Medicare and Medicaid Services (CMS) issued the 2016 Medicare Fee Schedule (the "Schedule") in an effort to facilitate compliance with the Physician Self-Referral Law (the "Stark Law"). Generally, absent an...more

OIG Issues New Exclusion and CIA Guidance

On April 18, 2016, Inspector General Daniel R. Levinson announced the publication of updated guidance on how the Office of Inspector General (OIG) makes decisions about using its permissive exclusion authority and requiring...more

Aetna Wins $37.5 Million for Overbilling Scheme

It’s easy to fall into the habit of regarding self-referrals and kickbacks as strictly a matter of federal law, governed only by the federal Stark Law and Anti-Kickback Statute. But an April 13 verdict in California provides...more

Assess and enhance your compliance program in this time of elevated risks

Continuous changes in the healthcare industry are delivering exciting innovations and new opportunities, but they are also creating new threats. Healthcare organizations face changing operational and enforcement environments...more

New Stark Law Exception Breathes Life into Primary Care, Especially in Underserved Areas

With the recent and significant shortages of primary care providers, the Centers for Medicare & Medicaid Services (“CMS”) recently created a rather important exception to the Stark Law as a means to expand access to primary...more

U.S. Sides with Defendant Against Whistleblower—Sort of

Today’s riddle: why would the government take the defendant’s side against the whistleblower in a False Claims Act qui tam case? Why would the government challenge the whistleblower’s claim that two defendants violated the...more

Analysis of New Timeshare Arrangement Exception to the Stark Law – Part 2

In a previous post, we analyzed the new Timeshare Arrangement exception to the Stark law that CMS proposed and went into effect on January 1, 2016. Here we give an example of how the new timeshare arrangement exception works...more

Analysis of New Timeshare Arrangement Exception to the Stark Law – Part 1

On July 15, 2015, the Centers for Medicare & Medicaid Services (CMS) proposed a series of rules that would create new exceptions to the Stark law, in addition to clarifying other provisions of the Stark law. One of the newly...more

Corporate Investigations & White Collar Defense - February 2016

Eye on the Courts—Recent Opinions and Rulings of Note - Why it matters: From a white collar and securities fraud standpoint, there has been a lot of noteworthy activity in the courts of late. The Supreme Court granted...more

The Deeper Dive: The Final Overpayment Rule

The Centers for Medicare and Medicaid Services (CMS) recently issued its final rule for Reporting and Returning of Overpayments (Final Rule). The Final Rule implements section 1128J(d) of the Social Security Act, which...more

New Stark Law Exception for Non-Physician Practitioner Subsidies: A Gift or Pandora's Box for Hospitals?

As of January 1, 2016, a new Stark Law exception allows hospitals to give subsidies to physician practices for the recruitment of non-physician practitioners (“NPPs”). In the Phase III Stark Law regulations, the Centers for...more

Stark: A Stagnant Law For An Evolving Industry

The Stark Law was originally enacted by Congress in 1989 as the Ethics in Patient Referrals Act. Initially, it prohibited a physician from referring Medicare beneficiaries to clinical labs in which the physician had an...more

DOJ Reaches $3.28 Million Stark Settlement with San Diego Hospital

Tri-City Medical Center will pay $3.28 million to settle alleged Stark Law violations that stemmed from financial arrangements with its former chief of staff and paperwork problems in more than 90 of its physician agreements....more

Another Day, Another Whistleblower Retaliation Suit

A False Claims Act (“FCA”) retaliation claim, 31 U.S.C. 3730(h), filed January 26, 2016 in federal district court in Oregon, provides a perfect example of the type of challenging cases confronting health care employers today....more

Health Care E-Note - January 2016

The 2016 Medicare Physician Fee Schedule Final Rule ("Final Rule") contains recent changes to the Federal Stark Law, the majority of which took effect on January 1, 2016. The issuance of the Final Rule on November 16, 2015...more

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