Pierce & Mandell, P.C.

11 Beacon Street, Suite 800
Boston, Massachusetts 02108-3002

Phone: (617) 720-2444
Fax: (617) 720-3693

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Mandatory Compliance and Ethics Programs for Nursing Homes

William M. Mandell - Thursday, February 21, 2013
By: Rebecca J. Merrill, Esq.

Time is Running Out: March 23rd is the Deadline for Nursing Facilities to Implement Mandatory Compliance & Ethics Programs

On or before March 23, 2013, Medicare and/or Medicaid certified nursing facilities must have in operation a Compliance & Ethics Program that is effective in promoting quality of care and preventing and detecting criminal, civil and administrative violations under the Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148) (the “ACA”).  While the ACA clearly required the Secretary and Inspector General of the Department of Health and Human Services to issue regulations further defining the ACA Mandatory Compliance & Ethics program requirements by March, 23, 2012, no such regulations have been promulgated.  The lack of clarifying regulations, however, does not relieve nursing facilities of the statutory obligation to have in operation such a Compliance & Ethics Program. Fortunately, the Office of Inspector General has long been committed to guiding nursing facility providers in the development of voluntary compliance plans and such guidance is an excellent starting point for developing or reviewing and updating existing compliance programs and documents. See OIG Supplemental Compliance Program Guidance for Nursing Facilities, Sept. 2008; and OIG Original Compliance Program Guidance for Nursing Facilities, Mar. 2000.  

Section 6201 of the ACA also sets forth several critical elements that must be addressed in nursing facility compliance and ethics programs to meet the ACA mandate.  These elements include:

A. Established compliance standards and procedures to be followed by employees and other agents that are reasonably capable of reducing the prospect of criminal, civil, and administrative violations.

B. Assign overall responsibility for compliance oversight to specific individuals within high-level personnel of the organization to ensure adherence to compliance and ethics standards and procedures and provide such individuals with sufficient resources and authority to accomplish such compliance.

C. Use due care not to delegate substantial discretionary authority to individuals whom the organization knows, or should know, through the exercise of due diligence, had a propensity to engage in criminal, civil, and administrative violations.

D. Take steps to effectively communicate its compliance and ethics standards and procedures to all employees and organizational agents (e.g., require participation in training program; disseminate training materials that explain requirements in a practical manner).

E. Take reasonable steps to achieve compliance with its standards (e.g., utilize monitoring and auditing systems designed to detect criminal, civil, and administrative violations under the ACA by its employee and agents; employ and publicize a reporting system that enables employees and agents to report violations without fear of retribution).

F. Consistently enforce standards and procedures through appropriate disciplinary mechanisms, including, as appropriate, discipline of individuals responsible for the failure to detect an offense.

G. After an offense has been detected, take all reasonable steps to respond appropriately to the offense and prevent further offenses of a like nature (e.g., make necessary modifications to existing compliance and ethics program to better prevent and detect criminal, civil, and administrative violations).

H. Perform periodic reassessment of the existing compliance and ethics program to identify changes necessitated by organizational evolution and changes in public policy.  

All nursing facilities should undertake a comprehensive review of existing compliance and ethics policies, if any, and update or draft new policies to ensure that the facility meets the statutory requirements for the March 23, 2013, Mandatory Compliance & Ethics Programs for CMS Certified Nursing Facilities.  The Health Care Team at Pierce & Mandell, P.C. is equipped and prepared to assist your facility in developing or updating its compliance and ethics standards and procedures.  

Apologizing for Medical Mistakes

William M. Mandell - Wednesday, February 06, 2013
By Dean P. Nicastro

Massachusetts health care providers (including hospitals, clinics, nursing homes, physicians, dentists, podiatrists, chiropractors, nurses, etc.) are now subject to the benefits and challenges of a new health care law impacting the arena of medical mistakes.  Section 79L of Massachusetts General Laws Chapter 233, which took effect November 4, 2012, the so-called “Disclosure and Apology Law,” protects a health care provider’s real-time statements expressing apology, sympathy, mistake or error (“apology,” for short) from being admissible as evidence against the provider in a medical malpractice case or in an administrative proceeding (for example, a medical board disciplinary proceeding).  Specifically, when the statement relates to an “unanticipated” medical outcome and when a provider communicates it to a patient or to the patient’s relative or representative, the law sets forth the general rule that the “apology” is not admissible.

However, the law makes exception for apology statements when the health care provider (or his/her defense expert witness) “makes a contradictory or inconsistent statement as to material facts or opinions,” when questioned under oath during the litigation.  In this case, the apology is admissible in evidence for all purposes.  Because this exception is not defined, plaintiffs and defendants may take to arguing over whether a particular subsequent statement made during testimony by the provider, or by the provider’s expert witness, is in fact inconsistent or contradictory to the original statement of apology.

The new apology law also imposes upon providers an obligation to “fully inform the patient and, when appropriate, the patient’s family,” about an unanticipated outcomewith significant medical complication resulting from the provider’s mistake.”  Because the term “significant medical complication” is not defined, questions of interpretation may arise, for purposes of determining just when the obligation to inform (disclose) applies in a given situation.    

The Massachusetts Medical Society sponsored the enactment of the Disclosure and Apology Law.  It is meant to be an innovative way to promote transparency, reduce litigation, and lower the costs of the health care system.  Future judicial interpretation will aid in understanding the full scope of its benefits.   Providers, in the meantime, will want to proceed carefully, and may wish to consult expert assistance, in proceeding under this statute.    

For more information on health care law, contact Pierce and Mandell, P.C.


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