Administrative Agency Health Civil Remedies

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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

CMS Solicits Comments Regarding Options for Beneficiaries to Satisfy Their Obligations Under the MSP Statute for Settlements...

In an Advanced Notice of Proposed Rulemaking (ANPR) published in the Federal Register on June 15, 2012, CMS is soliciting public comments on proposed standardized options for Medicare beneficiaries to resolve their...more

D.C. Circuit Confirms Broader Applicability Of Net Loss Approach To FCA Damages Calculations

Damages To Federal Health Care Programs Under The False Claims Act Are Reduced By The Value Of The Goods Or Services Provided By Defendant Last week, the D.C. Circuit held in United States of America, ex rel. Davis v....more

G2 Compliance Report -- Keeping the Whistle Away From the Whistleblower: The Laboratory Compliance Officer’s Role in Qui Tam...

Do you, as a laboratory compliance officer, want to spare your employer the disruption, expense, and burden of a government enforcement action? The answer, of course, is “yes.” The most effective and efficient way of doing so...more

New Law Extends Georgia False Claims Liability to Non-Medicaid Claims: Significant Revisions Also Made to Existing State False...

Introduction On April 16, 2012, Georgia Governor Nathan Deal signed into law House Bill 822, thereby enacting the new “Georgia Taxpayer Protection False Claims Act,” while also making significant revisions to the...more

Health Law Alert: Walgreens Settles Gift Card False Claims Act Allegations

The United States Department of Justice announced recently that Walgreens had agreed to settle federal False Claims Act allegations arising out of a prescription gift card program. The $9.2 million settlement concluded an...more

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