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Medical Directors, Surveys and the Law

      Medical directors play an essential role in the care that residents receive in the post-acute and long-term care arena. They wear many hats, ranging from thought leader and role model to clinical resource and educator. In particular, medical directors have a pivotal role in the survey process and defending a facility.
      As noted in a 2011 white paper from AMDA – The Society for Post-Acute and Long-Term Care Medicine, “The Nursing Home Medical Director: Leader and Manager” (http://bit.ly/3ah8uLJ), “the medical director is involved at all levels of individualized patient care and supervision, and for all persons served by the facility.” When CMS published its Final Rule in October 2016, it expanded the role of the medical director to be responsible for “implementing resident care policies and coordinating medical care in the facility” (Medicaid and Medicare Programs; Reform of Requirements for Long Term Care Facilities, Fed Regist 2016;81:68688–68872; codified at 42 CFR § 483.70(h), effective November 28, 2017; http://bit.ly/38fnRmx).
      Regarding surveys, the role of the medical director can be categorized into (1) before the survey, (2) during the survey, and (3) after the survey.

      Before the Survey

      An old axiom states, “An ounce of prevention is better than a pound of cure.” Likewise, being prepared for surveys is a prudent approach. Surveys by CMS agents, typically from the state’s department of health, generally fall into either recertification surveys or complaint investigations. Regardless of the survey’s source, the medical director’s role is critical.
      If a facility is effectively implementing appropriate policies and procedures across the spectrum of issues it confronts, it ought to be in good stead to demonstrate that it is in substantial compliance with the CMS Requirements for Participation.
      Medical directors should be familiar with the list of responsibilities that CMS and surveyors will focus on during surveys, as well as how CMS directs surveyors to determine if the medical director is in substantial compliance with the regulatory requirements (CMS, State Operations Manual, Appendix PP: Guidance to Surveyors for Long Term Care Facilities, F841; https://go.cms.gov/2I3aevU).

      During the Survey

      Surveyors will frequently interview a medical director in person or by phone during the course of a survey. The input of a medical director can be critical in determining an outcome, such as whether or not there are alleged deficiencies.
      I am familiar with instances where a well-meaning surveyor believed that a resident’s negative outcome was caused by substandard care, only to have the issue clarified by the medical director. For example, as every physician knows, some pressure sores and some falls are unavoidable in spite of a facility’s best efforts. CMS recognizes this fact as well, but not all surveyors fully appreciate that some clinical outcomes are unavoidable.
      In one recent situation, a surveyor was preparing to recommend an “immediate jeopardy” level deficiency to her supervisors regarding the care a resident had received. Only when the medical director, who also happened to be the attending physician, intervened did the surveyor understand that there was no basis for a deficiency. Although other team members such as the director of nursing and other clinical staff will be interviewed, the interview with the medical director can be highly persuasive to a surveyor.

      After the Survey

      A medical director has two primary roles after a survey. If the survey determined legitimate and factually accurate deficiencies, the medical director can assist the facility in correcting those deficiencies. This can be done in a number of ways, ranging from reviewing and revising policies and procedures as necessary to active input in the facility’s Quality Assurance Performance Improvement (QAPI) program and Quality Assessment and Assurance (QAA) committee. Note that even if the medical director delegates his or her role on the QAA committee to another physician, the medical director still retains responsibility, according to CMS.
      For the 20 years that I have been litigating CMS enforcement cases, I have always used members of the Society who are Certified Medical Directors (CMD) as medical experts. The skills and expertise of these formidable medical experts have proved invaluable, both when I represented CMS and for the last seven and a half years as I have represented nursing homes around the country. My reason is simple: members of the Society who have achieved the CMD designation have demonstrated their clinical competency and commitment to the highest levels of quality care. The Administrative Law Judges (ALJ) who determine the outcome of facility appeals also are aware of the Society’s high standards and the significance of the CMD status.

      A Persuasive Role

      A number of years ago I represented CMS in a case involving cardiopulmonary resuscitation (CPR). Essentially, an alert and oriented resident who had “full-code” status had a witnessed cardiac arrest. The facility’s nurses and a respiratory therapist performed CPR for two cycles of chest compression (approximately 30 seconds) and then abruptly ended their efforts. They did not call 911. When they terminated CPR after less than a minute, the resident was not resuscitated. CMS imposed a civil money penalty, which the facility appealed.
      At their appeal, the facility called Dr. Cyril Wecht, MD, JD, an internationally renowned forensic pathologist, as their expert witness. I argued that the issue was not the cause of death but whether the CPR administered by the facility was consistent with the accepted standards of care. Incredibly, Dr. Wecht testified that only two cycles of chest compression and no call to 911 were indeed within the standards of care for CPR in a witnessed cardiac arrest.
      I vigorously cross-examined Dr. Wecht’s surprising testimony, but I thought it would be best to have the testimony of a physician who could rebut the world-famous pathologist: I called Dr. Steven Levenson, a member of the Society. The ALJ found Dr. Levenson’s testimony far more credible and compelling: “CMS presented an expert witness, Steven A. Levenson, M.D., who has extensive experience in the long-term care field and with federal regulations. He testified credibly and persuasively about the ethics of when CPR should be initiated and how long it should last.” The ALJ added, “I found the procedures preferred by Dr. Levenson, who has written and studied in this area of medical ethics, to be far more persuasive [than those of Dr. Wecht]” (John J. Kane Regional Center – Glen Hazel v. CMS, CRD No. CR1394 [2006], aff’d DAB No. 2068 [2007]). Thus, a medical director affiliated with the Society was determined to be “far more persuasive” than a world-famous forensic pathologist.
      The CPR case is only one example of the many times I have called on a medical director from the Society in an appeal where a CMS enforcement action was being challenged. Based on my own experience, there is no doubt that a medical director’s persuasive testimony can make the difference in an appeal of a CMS enforcement action.

      A Challenging Role

      There are many valid reasons for challenging unsustainable deficiencies. Alleged deficiencies can result in civil money penalties in the high six-figure range, frequently over $1 million. Additionally, lower 5-Star Quality ratings, higher insurance premiums, and adverse publicity often follow an immediate jeopardy allegation.
      When alleged deficiencies turn out to be legitimate, the medical director can assist in correcting the underlying causes. However, when deficiencies are wrongfully alleged — as often occurs — the medical director’s input can help the ALJ correctly decide the case. Challenges also may incentivize CMS to rethink unsupportable deficiencies.
      In either case, the medical director has a key role to play. The medical director can help steer the facility in the right direction and maintain the focus on providing the highest quality of care.
      Mr. Horowitz is a partner at Arnall Golden Gregory LLP. His practice involves regulatory compliance concerning skilled nursing facilities, hospices, and home health agencies. Prior to joining the firm, he served as Assistant Regional Counsel at the U.S. Department of Health and Human Services and represented the Centers for Medicare & Medicaid Services. Mr. Horowitz also has an extensive experience as health care provider.