On December 30, 2015, the Centers for Medicare and Medicaid Services (CMS) issued a final rule establishing a prior authorization process for certain durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) items that the government maintains are typically subject to unnecessary utilization (i.e. items that do not comply with Medicare’s coverage, coding, and payment rules). CMS intends the prior authorization process to ensure that all Medicare coverage, coding, and payment rules are met before the DMEPOS items are furnished to a beneficiary and submitted for payment.
GAO recommends the same Medicare payment rates for evaluation and management services performed in all provider settings
The United States Government Accountability Office (GAO) has recommended that Congress consider directing the Secretary of the Department of Health and Human Services (Secretary) to equalize Medicare payment rates for evaluation and management (E/M) services, and other services that the Secretary deems appropriate, performed in all provider settings.
Federal court denies Texas Medical Board motion to dismiss Teladoc lawsuit
The Teladoc lawsuit against the Texas Medical Board (the “TMB”) regarding a rule that would require physicians to meet with patients face-to-face prior to prescribing medication will continue to move forward following a federal judge’s denial of the TMB’s request
Drug industry voices concerns with Quality Metrics Guidance
Overview of the Quality Metrics Guidance
In July, the U.S. Food and Drug Administration (FDA) released draft guidance detailing the FDA’s plan to collect quality metrics for the pharmaceutical industry in order to monitor quality control systems and processes within the industry. As we explained in an earlier post, the goal of the metrics collection is to drive continuous improvements in the drug development and manufacturing sectors. While the pharmaceutical industry groups state that they support the guidance generally, they are reportedly concerned about the resulting cost and time burdens on the industry, the implementation timeframe, the use of a draft guidance versus the use of a rulemaking process for the requirements, and the lack of clarity about the agency’s intended use of the collected data. As an overview, the data to be collected include:
Australian health and life insurers race into wearable technology
Just as telematics has been supplementing motor vehicle insurance underwriting, Australia’s health and life insurance markets are embracing innovative technologies in the form of “wearables”.
Supreme court to consider viability of False Claims Act implied certification theory
On Friday, the US Supreme Court agreed to consider two questions involving the so-called “implied certification theory” under the federal False Claims Act (FCA). First, the Court will consider whether the implied certification theory is ever viable for establishing FCA
DOJ announces US$3.5bn of FCA recoveries in FY 2015
Biggest year ever for declined qui tams
On December 3, 2015, the Department of Justice announced that it had recovered more than US$3.5 billion in settlements and judgments from civil cases involving fraud and false claims against the government
CMS issues final rule on mandatory bundled payment model for hip and knee surgeries
On November 24, 2015, the Centers for Medicare and Medicaid Services (CMS) issued a final rule implementing the Comprehensive Care for Joint Replacement (CJR) payment model. Under the CJR model, 67 acute care hospitals located in randomly selected metropolitan areas
Commonwealth issues new imported food controls
Australian Agriculture Minister, Barnaby Joyce, has introduced new orders designed to complete the Government’s changes to the Imported Food Control Regulations (Regulations) in respect of recognised foreign government certification.
In March 2015, the Government amended the Regulations to
FDA finalizes FSMA Foreign Supplier verification programs rule
On November 16, 2015, the Food and Drug Administration (“FDA”) finalized the Foreign Supplier Verification Programs rule (“FSVP”) for importers of food for humans and animals under the Food Safety Modernization Act (“FSMA”).
The final rule lays out risk-based requirements