News & Analysis as of

Final Stark Law Regulations Published by CMS

As previously discussed here and on our Health Industry Washington Watch blog here the Centers for Medicare & Medicaid Services (CMS) has released final regulations under the physician self-referral law known as the Stark...more

Summary of 2016 CMS Final Rule for Advance Care Planning

On October 30, 2015, the Centers for Medicare & Medicaid Services (“CMS”) issued the 2016 final Medicare payment rules for physicians, hospitals and other providers. The rules include a provision that empowers patients,...more

KBML Issues Guidance to Help Physicians Get the Most out of MOST

The Kentucky Board of Medical Licensure (“KBML”) issued a recent opinion regarding the Medical Orders for Scope of Treatment (“MOST”) form. The stated purpose of the opinion is to “encourage and promote clarification of a...more

Maryland Court of Appeals Holds that Expert Is Not Permitted to Opine as to Source of Lead Paint Exposure Based Solely Upon...

On October 16, 2015, in Jakeem Roy v. Sandra B. Dackman, et al., No. 6, Sept. Term 2015 (Md. Oct. 16, 2015), the Court of Appeals of Maryland held that a pediatrician is not qualified to offer an expert opinion regarding the...more

CMS Finalizes Controversial Changes to "2-Midnight Rule" for Inpatient Stays

On October 30, 2015, the Centers for Medicare & Medicaid Services (CMS) released its final rule updating the Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System for...more

HIPAA Lessons from the Warner Chilcott Settlement

Last week, the US Attorney’s Office in Boston announced that drug company Warner Chilcott agreed to plead guilty to health care fraud and pay $125 million to resolve criminal and civil liability arising out of allegations...more

Contracts May Not Be All They're Cracked Up To Be: The Extension Of Legal Protections In Employee Contractual Settings

For many years, employers have generally embraced a policy of utilizing at-will employment as often as possible, where employers and employees can end their relationship with each other at any time and for any (legal) reason....more

Federal Preemption and Peer Review - A New Frontier

It’s not often that we get to blog about a new area of federal preemption, but we do so today. This isn’t a big area, otherwise we would have known about it before, but it is pertinent to drug and medical device product...more

Final Curtain Call for Tuomey: Long-Running FCA/Stark Case Settled

After 10 years of litigation, including two trials and appeals to the 4th Circuit Court of Appeals, the U.S. Department of Justice (DOJ) and Tuomey Healthcare System (Tuomey) have entered into a settlement of DOJ's action...more

FTC Gives Mixed Review of South Carolina’s Nurse Supervision Proposal

The Federal Trade Commission (FTC or Commission) submitted written comments on November 2nd to South Carolina’s state legislature on the competitive impact of proposals to modify the supervision requirements for advanced...more

Advisory Opinion: Free van shuttle services to medical facilities

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...more

Prosecutors win rare murder conviction of M.D. in prescription drug deaths

The Centers for Disease Control and Prevention offers but one voice among many that has declared that the United States is in the midst of a prescription drug abuse epidemic. As the CDC notes: “Since 1999, the amount of...more

Limited Modifications in Final ACO Fraud and Abuse Waivers Most Notably Include Cut of Gainsharing CMP Waiver

Nearly four years after publishing their joint interim final rule with comment period, effective November 2, 2011 (IFC), the OIG and CMS (Agencies) have finalized the waivers of various fraud and abuse laws in the context of...more

CMS Finalizes Significant Changes to the Two Midnight Rule in the 2016 OPPS Final Rule

On October 30, 2015, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year 2016 Outpatient Prospective Payment System Final Rule (2016 OPPS Final Rule). In the 2016 OPPS Final Rule, CMS finalizes...more

Reimbursement Change for Off-Campus Provider-Based Clinics, Physician Offices, and Ambulatory Surgical Centers

On November 2, 2015, President Obama signed the Bipartisan Budget Act of 2015, a two-year budget deal with a key provision affecting hospitals and other health care providers. Effective January 1, 2017, the Act decreases the...more

CMS finalizes significant Stark Law rulemaking

In July of this year, the US Department of Health & Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) proposed significant changes to the regulations implementing the federal physician self referral law...more

Justice Department Charges Pharma President with Kickback Conspiracy

In the public relations battle following the issuance of the Yates Memo, the Justice Department can now cite one example for the new policy – the recent arrest and charging of Carl Reichel, former President of Warner...more

Record-breaking FCA settlements underscore importance of Stark Law compliance

In September and October, the Department of Justice (DOJ) announced four record-breaking False Claims Act settlements – ranging from $25 million to $115 million – involving health care systems that allegedly made improper...more

CMS Publishes Proposed Rule on Hospital/HHA Discharge Planning Requirements

On November 3, 2015, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule that would modify the discharge planning conditions of participation (COPs) for hospitals, including long-term care hospitals...more

CMS/OIG Finalize Fraud Authority Waivers for Accountable Care Organizations (ACOs) under the Medicare Shared Savings Program...

The Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) have finalized a rule designed to “remove legal and regulatory barriers that can impede care coordination in furtherance of the...more

Florida Constitutional Provision Mandating Disclosure of Adverse Medical Incidents Preempted by Federal Patient Safety and Quality...

The First District Court of Appeal in Florida recently held in Baptist Hospital of Florida, Inc. v. Jean Charles, Jr., No. 1D15-0109, October 28, 2015, that a Florida constitutional provision mandating disclosure of adverse...more

Congress Take Step Toward Site-Neutral Medicare Payments in Bipartisan Budget Act of 2015

On October 28, 2015, the U.S. House of Representatives approved legislation that, if enacted, would, among other things, substantially alter how and how much Medicare pays for outpatient services furnished by hospitals. The...more

Healthcare Legal News: Volume 5, Number 4: HHS’s New Anti-Discrimination Regulation Proposal, Explained

In September, the Department of Health and Human Services (HHS) released proposed anti-discrimination regulations that, if adopted, change the playing field in which physicians and other healthcare providers practice. These...more

Insurers May Not Terminate Physicians for Recommending Out-of-Network Providers

Under a new Texas law, effective September 1, 2015, health maintenance organizations (HMOs) and Preferred Provider Benefit Plans (PPO) (collectively referred to as "Insurers") can no longer terminate a physician from their...more

Minimizing Exposure to Stark Law Liability in False Claims Act Cases by Isolating Those Who Determine Fair Market Value From Those...

I. Stark Law and False Claims Act - The FCA has become the primary enforcement vehicle for the Ethics in Patient Referrals Act, better known as the Stark Law. There are now more than 150 public cases citing to both the...more

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