Life Sciences Legal Update : Life Sciences Lawyers & Attorneys : Reed Smith Law Firm : Healthcare, Food and Drug Law, Biotechnology, Privacy, Product Liability

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. 

We'll keep you posted as things progress . . .

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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 Although originally enacted in 1989 to create "bright line" to demark improper physician self-referred laboratory services, and expanded in 1993 to cover a wide range of "designated health services" reimbursable under Medicare, the contours of the Stark Law continue to evolve and new uncertainties emerge.

The significant damages that can result from a Stark Law violation — most particularly the prospect under the False Claims Act for recovery of three times the Medicare reimbursement paid as a result of a prohibited referral — has caused the Stark Law to attract increasing attention from U.S. Attorneys offices and the private qui tam relator bar.

In his article "Stark Law Developments Will Challenge Health Care Attorneys," published in The Legal Intelligencer, Reed Smith Partner Karl Thallner discusses recent developments demonstrating the difficulties in counseling health care clients on the application of the Stark Law, as well as with selecting a course of action when a Stark Law violation has been discovered.

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This post was written by Daniel A. Cody, Scot T. Hasselman, Carol C. Loepere and Debra A. McCurdy.

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.

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This post was written by George M. Linge and Natalie C. Metropulos.

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.

In Barrick v. Holy Spirit Hospital of the Sisters of Christian Charity, No. 1856 MDA 2009, 2010 PA Super 170 (Pa. Super. Sept. 16, 2010), Carl Barrick claimed to be injured when the chair he was sitting on in a hospital cafeteria collapsed. Barrick was treated by Dr. Thomas Green, whom plaintiff’s counsel also identified as an expert. In discovery, plaintiff’s counsel produced the medical treatment records but, citing the privilege afforded attorney-work product, refused to produce communications between plaintiff’s counsel and Dr. Green. Following an in camera review, the trial court concluded that the communications between counsel and the expert were discoverable.

On appeal, the Pennsylvania Superior Court affirmed, finding that “if an expert witness is being called to advance a party’s case-in-chief, the expert’s opinion and testimony may be impacted by correspondence and communications with the party’s counsel; therefore, the attorney’s work-product must yield to discovery of those communications.”  To learn more about the recognized tension between two basic state rules of discovery in this case: Rule 4003.3, which limits the scope of production of an attorney’s trial preparation materials; and Rule 4003.5, which permits “discovery of the facts known and opinions held by an expert” that are “acquired or developed in anticipation of litigation or for trial," read our full alert.

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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 “highly similar” (biosimilar) to, or “interchangeable” with, an FDA-licensed biological product. The notice outlines many implementation issues on which the agency seeks stakeholder feedback. In particular, the FDA raises a series of questions in the following areas: scientific and technical factors related to a determination of biosimilarity or interchangeability; the type of information that may be used to support a determination of biosimilarity or interchangeability; development of a framework for optimal pharmacovigilance for biosimilar and interchangeable biological products; scope of the revised definition of a “biological product”; priorities for guidance development; scientific and technical factors related to reference product exclusivity; scientific and technical factors that may inform the agency’s interpretation of “product class” as it relates to available regulatory pathways for certain protein products during the 10-year transition period following enactment of the BPCI Act; and the establishment of a user fee program for biosimilar and interchangeable biological products (the FDA seeks information about particular companies and trade associations that would be potential participants in any negotiations regarding user fee programs for biosimilars). Attendance will be on a first come-first served basis, although the meeting also will be webcast. Individuals who wish to present at the public hearing must register by October 11. Electronic or written comments also will be accepted until December 31, 2010.

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