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Commission Holds FTC Unfairness Claim Does Not Require “Probable” or Tangible Injury in LabMD Data Security Case

The Federal Trade Commission unanimously (3-0) ruled on July 29, 2016 that LabMD’s data security practices were “unfair” under Section 5 of the FTC Act, reversing a decision of its Administrative Law Judge (ALJ). As we...more

Final CMS Rule Provides Long-Awaited Clarity on Reporting and Returning Medicare Overpayments

On February 12, 2016, the Centers for Medicare & Medicaid Services (CMS) published its long-anticipated Final Rule implementing Section 6402(a) of the Patient Protection and Affordable Care Act (ACA) (section 1128J(d) of the...more

FTC Theory of Unrealized Consumer Injury Rejected in LabMD Data Security Case

In what could be a major setback for the Federal Trade Commission (FTC) in the data security arena, an Administrative Law Judge (ALJ) has ruled that an unfairness claim brought by the FTC under Section 5 of the FTC Act...more

OIG Warns Lab “Pull-Through” Arrangements May Be Illegal

In an important advisory opinion, the U.S. Department of Health and Human Services Office of Inspector General (OIG) gave a thumbs-down to a proposed clinical laboratory “pull-through” arrangement even though the patients in...more

Supreme Court Strikes Down State Professional Boards’ Antitrust Immunity

In a ruling with significant implications for state professional licensing boards and their members, on February 25, 2015, the United States Supreme Court found that practitioner-controlled state boards do not have inherent...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

Oregon Settlement Expands Disclosure Obligations Of Physicians Receiving Payments From Drug And Device Manufacturers

As of August 1, 2013, pharmaceutical companies and medical device manufacturers are required to report to the federal government payments made to physicians under the Physician Payment Sunshine Act (PPSA). ...more

8/23/2013

CMS Adopts New “2 Midnights” Presumption For Inpatient Hospital Admissions

On August 2, 2013, the Centers for Medicare and Medicaid Services (CMS) issued an advance copy of its final rulemaking that adopts a new approach to evaluating the medical necessity of inpatient hospital admissions. ...more

Hospitals Provided Temporary Relief In Medicare Rebilling Policy

The Centers for Medicare & Medicaid Services (CMS) released a ruling and an interim rule that, effective immediately, will allow hospitals to rebill certain inpatient hospital services as outpatient services for one year...more

U.S. Supreme Court Holds Equitable Tolling Doctrine Does Not Apply To Administrative Appeal Deadline

On January 22, 2013, the U.S. Supreme Court issued a unanimous decision in Sebelius v. Auburn Regional Medical Center, 568 U.S. _____ (2013), holding that hospitals cannot appeal Medicare inpatient reimbursement...more

In Landmark Decision, Second Circuit Reverses Conviction For Off-Label Promotion

On December 3, 2012, in United States v. Caronia, a three-judge panel of the Second Circuit reversed a drug salesperson’s conviction for conspiracy to introduce a misbranded drug into interstate commerce, a misdemeanor...more

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