Health Civil Remedies Administrative Agency

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Be Careful What You Say: Allegations Of Worker Misconduct Might Be Defamation

Healthcare institutions have a moral and legal obligation to promote patient safety as an essential component of patient care. Supervisors and managers must be supportive of their staffs while remaining vigilant about the...more

Amgen v. Sandoz: Federal Circuit Grants Injunction Pending Appeal

Yesterday the Federal Circuit granted Amgen’s motion for an injunction pending appeal in Amgen v. Sandoz, the first appeal to squarely address the patent litigation provisions of the Biologics Price Competition and Innovation...more

The Pitfalls of Settling Qui Tam Lawsuits

In a recent federal court case, the federal government and the State of California successfully enforced an oral settlement agreement of a qui tam lawsuit against a health care provider. United States v. North East Medical...more

The FCA and the Ever-Narrowing Public Disclosure Bar

On February 25, 2015, the Sixth Circuit became the latest federal court of appeals to weigh in on the scope of the False Claims Act’s (FCA) public disclosure bar in its decision in United States ex rel. Whipple v....more

Illinois Supreme Court Rejects Constitutional Challenge to Medical Licensing Amendments

Last month, a unanimous Illinois Supreme Court rejected assorted constitutional challenges to 2011 amendments to the Department of Professional Regulation Law governing medical licensing. In an opinion by Justice Burke, the...more

The Orphan Drug Wars: HHS’s Recent Loss to PhRMA

On May 27, 2014, almost a year following the promulgation of its final rule, the U.S. Department of Health and Human Services (HHS) had its rule vacated by the U.S. District Court for the District of Columbia under an...more

DC District Court Strikes Down 340B Orphan Drug Rule

On May 23, Judge Contreras of the U.S. District Court for the District of Columbia (DC District Court) ruled that the Health Resources and Services Administration (HRSA) did not have the statutory authority to promulgate its...more

AHA Challenges to the Two-Midnight Rule - Preserve Your Hospital's Right to Challenge

The American Hospital Association (AHA), along with several state and regional hospital associations and several hospitals, recently filed two lawsuits challenging CMS’s two-midnight rule and related policies....more

Complaint Filed Against HHS Alleges Medicare LCDs Deprive Beneficiaries of Necessary Clinical Laboratory Services

On April 18, 2014, California Clinical Laboratory Association (“CCLA”) and “Jane Doe” (collectively, “Plaintiffs”) filed a lawsuit against HHS for equitable relief in the United States District Court for the District of...more

OCR's Breach Settlement the First Ever Involving Less than 500 Patients

OCR started 2013 with a bang by announcing that it had reached “the first settlement involving a breach of unprotected electronic protected health information (ePHI) affecting fewer than 500 individuals” with the Hospice of...more

First OCR Settlement Involving a “Small” Breach Focuses on Mobile Device Security

In what is best understood as a follow-up to both the recent settlement with MEEI and the release of its mobile device security guidance, HHS OCR recently released details of a settlement reached with the Hospice of Northern...more

2/3 Of DOJ’s Nearly $5 Billion Recovery Under False Claims Act Derived From Whistleblower Suits in 2012

On December 4, the Justice Department announced a record-breaking recovery of $4.9 billion in settlements and judgments in civil cases brought under the False Claims Act (FCA) for the fiscal year ending September 20, 2012....more

Who Cares if I Give a COBRA Notice for My Dental Plan?

Employers are generally aware that medical plans are subject to continuation coverage under the federal law known as COBRA. They may forget that COBRA extends to all group health plans, including dental, vision and medical...more

Hospitals Win a Case Challenging CMS Policy to Include Part C Days in the SSI Fraction in the Medicare DSH Formula

On November 15, 2012, the United States District Court for the District of Columbia released a 33-page opinion ruling in favor of a group of hospitals that had challenged CMS’s policy of including Medicare Part C patient days...more

Healthcare Update, No. 4, November 2012: Hospital Receptionist Harassed By Patient – EEOC Sues

Today, most healthcare employers are sensitive to issues of workplace harassment, although the focus of that sensitivity is usually upon issues involving co-worker to co-worker and supervisor to subordinate conduct. It is...more

Proposed Settlement Would Prevent Medicare Denials for Chronically Ill and Disabled Due to Lack of Improvement

A proposed settlement has been reached between CMS and the plaintiffs in a national class action involving the denial of benefits to chronically ill and disabled Medicare beneficiaries. Many of these patients have had skilled...more

Proposed Settlement of Medicare Class Action Could Impact Chronic Care Benefits

On October 16, 2012, representatives of the parties in the nationwide class action lawsuit styled, Glenda Jimmo, et. al vs. Kathleen Sebelius filed a proposed legal settlement with the chief judge of the Federal District...more

Medicare Therapy Coverage Policy to Be Revised

Proposed class action settlement disavows and discontinues use of the "Improvement Standard." Under a proposed settlement of Jimmo v. Sebelius, No. 5:11-cv-00017 (D. Vt. filed Oct. 16, 2012) filed with the U.S....more

Supreme Court Will Not Review Sixth Circuit Ruling That Government May Seek Full Reimbursement of Medicare Payments to Beneficiary...

On October 1, 2012, the United States Supreme Court said it would not review a decision by the U.S. Court of Appeals for the Sixth Circuit which ruled 2-1 that, upon settlement by a Medicare beneficiary with a third-party...more

Government Sanctioned for Destruction of Documents

U.S. district court decision may now allow defendants in False Claims Act cases to obtain sanctions where potentially relevant documents are lost or destroyed due to the government's failure to issue a timely litigation...more

First State HIPAA Enforcement Action against a Business Associate Returns $2.5 Million Payout

In February, we alerted you to the first HIPAA enforcement action taken against a business associate. The action was pursued by the Minnesota Attorney General against Accretive Health, a service provider that was involved in...more

Alaska Medicaid Settles HIPAA Security Case for $1,700,000

The U.S. Department of Health and Human Services Office of Civil Rights (OCR) has announced the first HIPAA enforcement action OCR has taken against a State agency, and the resolution agreement and related corrective action...more

New PA Law Allows 8-80 Overtime Calculation Method

A newly enacted amendment to the Pennsylvania Minimum Wage Act expressly permits the use of the 8-80 method of calculating overtime, making clear that this method is permitted not only under federal law, but state law as...more

Medicare Seeks to Safeguard Its Share of “Future Medicals” from Liability Settlements

The Centers for Medicare & Medicaid Services (“CMS”) has issued an advance notice of proposed rulemaking (“Notice”), soliciting comments on options for how beneficiaries and their attorneys can comply with Medicare Secondary...more

Health Law Alert: In False Claims Litigation, Providers Cannot Invoke "No Harm, No Foul"

On the basketball court, the conventional wisdom is "no harm, no foul." It is not so in federal court, particularly in litigation involving the False Claims Act (FCA). The FCA allows the imposition of civil monetary...more

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