News & Analysis as of

SRDP No Longer New Wine

More than four years after the Centers for Medicare & Medicaid Services' (CMS) issuance of the Stark Self-Referral Disclosure Protocol (SRDP), it's time to assess the results. The SRDP was designed by Congress to resolve...more

Jury Verdict Against Millennium Provides Insight on Definition of Remuneration

Ameritox won the latest volley of an ongoing legal battle with Millennium when a federal jury in Florida awarded it $14.75 million on June 16, 2014. Ameritox persuaded the jury that Millennium’s free point of care test (POCT)...more

The Self-Referral Disclosure Protocol: Settlement and Enforcement Trends (Presentation)

The Self-referral Disclosure Protocol (SRDP) permits health care providers to voluntarily disclose violations of the federal physician self-referral law, also called the Stark law. Emily Wein has presented a webinar...more

The Deadline for Submitting Comments Regarding the Self-Referral Disclosure Protocol Is Fast Approaching

On May 2, 2014, the Centers for Medicare and Medicaid Services (“CMS”) published a request for comments relating to the Self-Referral Disclosure Protocol (“SRDP”). The SRDP is a voluntary self-disclosure instrument that...more

Stark Law Update: All Children’s Settles False Claims Act Allegations

All Children’s Health System (ACHS) will pay the federal government and state of Florida $7 million to settle allegations that it violated the federal and Florida False Claims Act statutes by submitting claims to Medicaid...more

CMS Self-referral Disclosure Protocol: 2013 Update and Summary of Settlements

The CMS Self-referral Disclosure Protocol – Background - Under delegated authority, the Centers for Medicare and Medicaid Services (CMS) released its Self-Referral Disclosure Protocol (SRDP) on September 23, 2010, with...more

New Rules Amend Regulatory Exceptions For Donation Of Electronic Health Records Items And Services

On December 27, 2013, the Department of Health and Human Services published two final rules, one amending the Office of Inspector General’s (OIG) Anti-Kickback safe harbor related to electronic health records (EHR) items and...more

CMS And OIG Release Final Rules Extending Stark Law Exception And Anti-Kickback Statute Safe Harbor For Donations Of Electronic...

In 2006, the Centers for Medicare & Medicaid Services ("CMS") and the Office of Inspector General of the Department of Health and Human Services (the "OIG") published final rules providing for an exception to the Stark Law...more

Health Reform + Related Health Policy News - December 2013

In This Issue: - Top News ..CMS Releases Payment Rules for the Medicare Physician Fee Schedule, Hospital Outpatient Prospective Payment System, Renal Dialysis and Home Health ..President Signs the Drug Quality...more

Health Reform + Related Health Policy News - October 2013

In This Issue: - Top News ..Judge Orders $237.4 Million Penalty Against Tuomey for Stark Law and False Claims Act Violations ..Glitches and Demand Lead to Marketplace Frustration ..HHS Delays Small...more

Hospitals And Compliance

Hospitals are being squeezed on many fronts – government reimbursement for medical services are declining, government regulatory requirements are increasing, and the prospects for improvement are dwindling. Medicare and...more

Mintz Levin Health Care Qui Tam Update - Recent Developments and Unsealed Cases

Trends and Analysis: ..We have identified 20 health care-related qui tam cases unsealed in July 2013. About a quarter of those were filed in 2013. ..Among the cases unsealed in July, the government has declined to...more

Electronic Health Records Donations: Proposed CMS And OIG Rules Revise Stark Exception And Anti-Kickback Safe Harbor

On April 10, 2013, the Centers for Medicare & Medicaid Services (‘‘CMS'') and the Office of the Inspector General of the Department of Health and Human Services (‘‘OIG'') published twin proposed rules that amend and extend...more

2013 Healthcare Fraud and Abuse Bootcamp Webinar Series, Part V: Compliance

Bill Mathias of Ober|Kaler's Health Law Group presented on compliance as a part of the 2013 Healthcare Fraud and Abuse Bootcamp Webinar Series sponsored by the American Health Lawyers Association. This webinar...more

HHS Extends Sunset Date for Stark Exception and Anti-Kickback Safe Harbor for EHR Donations

The Centers for Medicare & Medicaid Services and the U.S. Department of Health and Human Services issued proposed rules that would extend the sunset date for the Stark Law exception and the federal Anti-Kickback Statute safe...more

Recent CMS Guidance Partially Lifts Veil on Stark Self-referral Disclosure Protocol

In 2012, the Centers for Medicare and Medicaid (CMS) issued much-anticipated guidance on the Self-Referral Disclosure Protocol (SRDP) through its publication of thirteen settlements and its statutorily-mandated “Report to...more

OIG Advisory Opinion Sheds Light On Pay-For-Performance Relationships Between Hospitals And Physicians

On January 7, 2013, the HHS OIG released Advisory Opinion 12-22 concerning a rural hospital's (Hospital) proposal to pay a cardiology group (Group) a performance bonus for achieving certain patient service, quality and cost...more

The False Claims Act and Healthcare Providers: Key Results from 2012 and Likely Trends for 2013

From the perspective of False Claims Act (FCA) results, 2012 was a decidedly mixed year for healthcare providers. The bad news was quite bad—increased FCA scrutiny by the Department of Justice (DOJ) led to $3 billion of...more

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