According to a senior health information technology and privacy specialist at HHS Office for Civil Right (OCR), regulations finalizing the July 14, 2010, proposed rule implementing many of the HITECH Act's privacy, security, and enforcement requirements could be published by the end of 2010 or in early 2011. Additionally, OCR, developing a HITECH Act required "periodic audit" plan, which will be targeted to ensure that covered entities and business associates comply with the requirements of the Privacy and Security Rules.… Continue Reading
Despite the many years since enactment, counseling health care clients on the broad and complex federal physician self-referral law, commonly called the Stark Law, will become increasingly difficult. Although originally enacted in 1989 to create “bright line” to demark improper physician self-referred laboratory services, and expanded in 1993 to cover a wide range of “designated … Continue Reading
On September 23, 2010, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule that would implement provisions of the Affordable Care Act (ACA) designed to strengthen provider and supplier screening requirements under the Medicare, Medicaid, and Children's Health Insurance Program (CHIP). According to CMS, the Proposed Rule is intended to ensure "that only legitimate providers and suppliers are enrolled in Medicare, Medicaid, and CHIP, and that only legitimate claims will be paid."
Among many other things, the Proposed Rule would: apply screening tools, including unannounced site visits, background checks, and fingerprinting, based on the level of risk associated with different provider and supplier types; impose a $500 application fee on certain providers and suppliers; authorize temporary moratoria on enrollment of certain types of new providers and suppliers; require Medicare and Medicaid payments to be suspended upon credible allegations of fraud; and update various Medicaid screening requirements. Comments on the proposed rule will be accepted until November 16, 2010.
Our full alert provides an analysis of the proposed rule.… Continue Reading
Addressing an issue of first impression in Pennsylvania, the Pennsylvania Superior Court recently concluded that an attorney's communications with a testifying expert are discoverable. This important decision puts Pennsylvania law squarely at odds with the newly amended Federal Rule 26(b)(4), set to take effect December 1, 2010, which prohibits discovery of drafts of an expert's reports as well as communication between counsel and the expert. Now, as much as ever, it is critical to understand the venue-specific rules on communications with experts.… Continue Reading
Today the FDA published a notice announcing public hearings on November 2 and 3, 2010 on implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which was enacted as part of the Affordable Care Act (ACA). The BPCI Act establishes an abbreviated approval pathway for biological products that are demonstrated to be … Continue Reading