News & Analysis as of

Federal Judge Dismisses All Anti-Kickback Claims in Halifax Hospital Medical Center Case

On January 8, 2014, the U.S. district judge in the Halifax Hospital Medical Center (Hospital) case pending in the Middle District of Florida granted the Hospital's motion to dismiss all of the relator's anti-kickback law...more

CMS and the OIG Extend Protections for Electronic Health Record Donations

On December 27, 2013, the Office of Inspector General (“OIG”) and the Centers for Medicare & Medicaid Services (“CMS”) each published, in the Federal Register, a final rule that amends regulations under the Anti-Kickback...more

CMS and OIG Issue Final Regulations to Extend the Stark Exception and Anti-Kickback Statute Safe Harbor for EHR Donations

On December 27, 2013, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services’ Office of Inspector General (OIG) finalized amendments to the Physician Self-Referral Law (Stark) and...more

U.S. District Court Grants in Part, Denies in Part Halifax Hospital’s Summary Judgment for Relator’s Non-Intervened FCA Claims

On January 8th, a United States District Court in the Middle District of Florida granted in part, denied in part summary judgment in favor of Halifax Hospital Medical Center and certain other defendants (collectively, Halifax...more

Federal Government Extends Donated EHR Technology Protections under Stark and AKS through 2021

Some of the most important protections under the federal Stark Law (“Stark”) and the federal Anti-Kickback Statute (“AKS”) have been those that permit hospitals and other organizations to donate electronic health records...more

CMS and OIG Finalize Extension of Federal Stark Exception and Anti-Kickback Safe Harbor for Electronic Health Record Donations

On Friday, December 27, 2013, the Centers for Medicare & Medicaid Services (“CMS”) and the Office of the Inspector General (“OIG”) of the Department of Health and Human Services published complementary final rules in the...more

CMS and OIG Issue Final Rules Extending EHR Stark Law Exception and AKS Safeharbor to December 31, 2021

On December 27, 2013, CMS published a final rule in the Federal Register revising the previously enacted exception to the Stark law that permits certain arrangements involving the donation of electronic health records (EHR)...more

CMS & OIG Final Rules Extend And Amend Protection For EHR Donations

Ordinarily, the donation of Electronic Health Record (EHR) technology, services or training to a provider would raise fraud and abuse concerns and potentially implicate the Stark law and Anti-kickback Statute. In order to...more

Final EHR Donation Rules Issued in Time for the New Year

On December 27, 2013, the U.S. Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) issued final rules revising the Stark exception (42 CFR...more

The Long Sunset: EHR Donations May Continue Until 2021 (With a Few Changes)

Under long-awaited final rules recently published by the federal government, hospitals and other “protected donors” may continue to “donate” interoperable electronic health record items and services without incurring...more

Third Party Valuation No Silver Bullet in Health Care Deals

Drakeford v. Tuomey and U.S. vs. Bradford Regional Medical Center - With the Affordable Care Act and market forces driving consolidation and creative transactions across the health care industry, health care...more

Doc Wishes He Showed Up at the Office — But . . .

Imagimed LLC, an MRI Center, its owners and chief radiologist, agreed to pay the government $3.57 million to settle false claims allegations for MRI services. The government alleged that Imagimed billed for MRI scans...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

Justice Department Intervenes in Qui Tam Lawsuit Alleging Antikickback and Stark Violations

The Justice Department recently intervened in a qui tam lawsuit against a home health provider and related individuals, alleging violations of the antikickback statute and the Stark Law, which also constituted alleged...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

Doctors, Enforcement Risks And Compliance Programs

Doctors better get used to government regulation. The Affordable Healthcare Act contains a lengthy complement of new laws and regulations. ...more

Healthcare Providers And Self-Disclosure Of Violations

The healthcare industry has a long history of innovative compliance policies and strategies. ...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

Pharmaceutical And Medical Device Compliance: Domestic And Foreign Bribery

Pharmaceutical and medical device companies have a raw deal when it comes to domestic and foreign bribery. ...more

Capital Infusion: Private Equity Update - May 2013

In This Issue: - DIGGING DEEPER: A Guide to Health Care Regulatory Due Diligence in Private Equity Deals 1 - Policy Spotlight: Affordable Care Act 6 - Case Spotlight: Best Practices in Down-Round Financings &...more

CMS and OIG Propose Changes to the Electronic Health Records Exception and Safe Harbor

On April 10, 2013, the Centers for Medicare & Medicaid Services (“CMS”) and the Department of Health and Human Services Office of Inspector General (“OIG”) published parallel proposed rules revising, respectively, the Stark...more

Hospital And Physician Compliance With Anti-Kickback And Stark Restrictions

A bribe is a bribe. It is not as easy as it sounds. Not all payments of money or transfers of value are bribes. The FCPA tells us that. It is even more complicated when trying to navigate Anti-Kickback and Stark law...more

The Top 10 Things You Need To Know About The OIG’S Revised Self-Disclosure Protocol

On Wednesday, April 17, 2013, the Department of Health and Human Services’ Office of Inspector General (OIG) released an updated Self-Disclosure Protocol (SDP) governing the process by which health care providers can...more

OIG Unveils Updated Self-Disclosure Protocol

In 1998, the Department of Health and Human Services' Office of Inspector General ("OIG") published the Self-Disclosure Protocol ("SDP"), which provides a mechanism through which health care providers may voluntarily report...more

OIG and CMS Issue Proposals to Extend Safe Harbor and Exception for EHR Donations

In the April 10 Federal Register, two agencies within the U.S. Department of Health and Human Services published proposed rules that many healthcare providers have been anxiously awaiting affecting donations of electronic...more

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