Sebelius Issues Section 1135 Waiver

This post was written by Kevin Madagan and Paul Sheives.

On October 24, 2009, President Obama signed a proclamation declaring the 2009 H1N1 influenza pandemic a National Emergency to facilitate the nations ability to respond to the H1N1 pandemic by enabling – if warranted – the waiver of certain statutory federal requirements for medical treatment facilities.  

This proclamation provided Kathleen Sebelius, the Secretary of the U.S. Department of Health & Human Services, the ability under section 1135 of the Social Security Act [42 U.S.C. § 1320b–5] to waive certain legal requirements that could otherwise limit the ability of the nation’s healthcare system to respond to the surge of patients with the 2009 H1N1 influenza virus. 

Secretary Sebelius recently issued a Section 1135 waiver that becomes effective at 5:00 p.m. today but is retroactive to October 23, 2009.  

Accordingly, healthcare facilities may now petition the Department for 1135 waivers to ensure that sufficient healthcare items and services are available to meet the needs of Medicare, Medicaid, and CHIP beneficiaries. Listed below are a few examples of when 1135 waivers may be necessary:

  • Hospitals request to set up an alternative screening location for patients away from the hospital’s main campus (requiring waiver of sanctions for certain directions, relocations or transfers under EMTALA).
  • Hospitals request to facilitate transfer of patients from ERs and inpatient wards between hospitals (requiring waiver of sanctions under EMTALA regulations).
  • Critical Access Hospitals requesting waiver of 42 C.F.R. § 485.620, which requires a 25-bed limit and average patient stays less than 96 hours.
  • Skilled Nursing Facilities requesting a waiver of 42 C.F.R. § 483.5, which requires CMS approval prior to increasing the number of the facility’s certified beds.

New Evidence Rule 502: Inadvertent Waiver Of Attorney-Client Or Work Product Material

This post was written by Matthew R. Sheldon and Alexander "Sandy" Y. Thomas.

On September 19, 2008, President Bush signed into law the long-awaited Federal Rule of Evidence Rule 502; “Attorney-Client Privilege and Work Product; Limitations on Waiver” (“Rule 502”). Rule 502 addresses waiver of the attorney-client privilege and work product doctrine in the context of disclosures to a federal agency or during a federal proceeding.

Among other benefits, Rule 502 adds some needed clarity to the question of what constitutes a waiver if privileged or work product material is inadvertently disclosed to an opponent in litigation. It also addresses the scope of a waiver and the impact such a waiver may have in other federal and state court proceedings.

Prior to Rule 502’s enactment, federal courts generally took three positions regarding the issue of inadvertent disclosure. Some courts found that only an intentional disclosure acts as a waiver, providing clients with the highest level of protection. Other courts found that any inadvertent disclosure of privileged information, regardless of a corporation’s effort to avoid such a mistake, acted as a waiver. Most courts, however, adopted a “middle ground” approach wherein an inadvertent disclosure acts as a waiver only if the disclosing party was careless in disclosing privileged information and failed to request its return in a timely manner. Rule 502 mirrors the middle ground approach in many respects.

While adding clarity to the thorny issue of inadvertent disclosure, it remains to be seen if Rule 502 will have a substantial impact on litigation practices, especially in the context of electronic discovery. The principal purpose behind Rule 502 is to lower litigation costs associated with discovery by, among other things, reducing the potential impact of an inadvertent disclosure. As long as the producing party takes reasonable precautions to prevent an inadvertent disclosure, the provisions of Rule 502 will likely protect that party from a broad subject matter waiver if the party mistakenly discloses privileged or work product material to its adversary. With this added protection, parties are expected to direct fewer resources to privilege and work product reviews (i.e., parties will rely more heavily on less-expensive electronic searches for privileged and work product information), thereby reducing litigation costs. The enactors of Rule 502 also hope that fewer discovery battles will occur, given the increased clarity in the law of waiver provided by Rule 502.

Although Rule 502 may offer additional protection to parties who disclose privileged or work product material during litigation, counsel will in many instances still choose to conduct thorough privilege and work product reviews, considering that the cost of disclosing confidential information to your adversary remains high, even if the information is subsequently returned or if a court determines that disclosure of such information does not constitute a broad subject matter waiver. In addition, discovery disputes will still likely erupt over interpreting the specific provisions of Rule 502 and what actually constitutes “reasonable steps” to protect privileged and work product material.

Of equal importance is Rule 502’s requirement that any agreement between parties regarding the disclosure of privileged or work product material must be included in a court order if it is to be effective against third parties. Thus, counsel who wish to enter into an agreement with their adversary regarding the disclosure of privileged or work product information would be wise to make sure that the agreement is reduced to a court order.

Despite some of its deficiencies, Rule 502 is a step in the right direction. Confidential information of the client will receive enhanced protection, which is a welcome development in the face of recent assaults on the attorney-client privilege and work product doctrine.

More On the DOJ's Revised Principles of Federal Prosecution of Business Organizations

We previously wrote about how the Department of Justice (DOJ) revised its Principles of Federal Prosecution of Business Organizations, which govern how federal prosecutors investigate, charge, and prosecute corporate crimes, including health care fraud. Reed Smith's Matthew R. Sheldon, Alexander “Sandy” Y. Thomas, and Richard D. Kelley have written more on the subject.

Corporate Crime Prosecution Guidance

The Department of Justice (DOJ) has revised its Principles of Federal Prosecution of Business Organizations, which govern how federal prosecutors investigate, charge, and prosecute corporate crimes, including health care fraud. A number of the revisions address the area of cooperation credit, including providing that credit for cooperation will not depend on a corporation’s waiver of attorney-client privilege or work product protection, but rather on the disclosure of relevant facts. The guidelines also instruct prosecutors not to consider a corporation’s advancement of attorneys’ fees to employees when evaluating cooperativeness, and specify that the mere participation in a joint defense agreement will not render a corporation ineligible for cooperation credit. Moreover, prosecutors may not consider whether a corporation has sanctioned or retained culpable employees in evaluating whether to assign cooperation credit to the corporation.

Reed Smith's Health Industry Washington Watch blog has new posts about these guidelines as well as new FDA initiatives; Medicare DMEPOS accreditation requirements; the Medicare Part B drug CAP program; Congressional hearings and markups; OIG and GAO reports; upcoming health care industry events; and other policy developments.

Protection For The Attorney-Client Privilege?

In-house lawyers in many industries--including life sciences and health care--repeatedly confront hard questions about the attorney-client privilege. As Reed Smith lawyers Matthew Sheldon and Sandy Thomas explain in the PrivilEdge Newsletter, a number of recent developments warrant attention. These include "The Attorney-Client Privilege Protection Act of 2007"--pending legislation that would curb demands for waiver of the privilege during corporate investigations and a recent case addressing attorney-client privilege issues such as the "joint client" exception, protection for tax advice and internal audits, and corporate ratification of a lower-level employee's disclosure of privileged information. Their article also discusses proposed Rule of Evidence 502 (S. 2450) regarding inadvertent disclosure of privileged information. As of Monday, that bill is awaiting the President's signature.