Introduction to the Revised Federal Guidelines for Nursing Home Medical Directors: F-Tag 501

INTRODUCTION

The last few years have seen expansion of the scope of regulations covering nursing homes.¹ In June 2005, The Centers for Medicare & Medicaid Services (CMS) released the new surveyor guidelines for nursing home deficiency “Tag F501, Medical Director.” These include Interpretive Guidelines, Investigative Protocol, and Severity Guidance for deficiencies related to this F-tag.² This article will provide direction for medical directors in understanding the new regulations and how to meet regulatory expectations. It is also directed at those considering entry into this position, to appreciate the scope of responsibilities now required by law.

BRIEF HISTORY OF REGULATIONS PERTAINING TO MEDICAL DIRECTORS

The nursing home industry expanded rapidly in the post–World War II era. Several attempts to regulate the industry were made, but were deemed ineffective at preventing abuse of residents and maintaining quality of care. In the 1980s, Congress commissioned the Institute of Medicine (IoM) to study the need for nursing home regulation, which resulted in a detailed report that recommended radical expansion of regulations governing long-term care.³ These recommendations covered such topics as resident rights, physical and chemical restraints, resident assessment, quality of care, and training of staff. One of the IoM’s recommendations was mandatory presence of a medical director in each facility.⁴

Congress incorporated most of these recommendations into the Omnibus Budget Reconciliation Act of 1987 (OBRA ‘87), also called the Nursing Home Reform Amendments. In 1990, these regulations went into effect for all facilities receiving reimbursement from Medicare and/or Medicaid. Prior to these regulations, there was no requirement for medical direction in a nursing home.

The Medical Director Requirement Prior to November 2005
Section 483.75 of the Nursing Home Reform Amendments contains the specific clause requiring facilities to have a medical director. The wording is simple, brief, and to the point:

The medical director is responsible for—
     (i) Implementation of medical care policies; and
     (ii) The coordination of medical care in the facility.

The teeth of the regulation are contained in the Guidance to Surveyors, originally issued by the Health Care Financing Administration (HCFA), now CMS. These guidelines contain the “federal tags” under which facilities are cited, and the Investigative Protocols to assist surveyors in gathering data to justify the deficiency.

The original wording in the Guidance to Surveyors that pertains to “Tag F501, Medical Director” released in 1990 was broad and vague. Requirements of the medical director were defined by terms as “appropriate care,” “significant role,” and “appropriate steps.” There were no investigative protocols for surveyors to follow, and no formal method for surveyors to tie the medical director and physician staff to deficiencies in other areas of care. Physicians and medical directors were thus “out of the loop” when facilities were cited, because there were no formal criteria for compliance.

THE NEW MEDICAL DIRECTOR REQUIREMENT

The revised Interpretive Guidelines now spell out the expectations of the medical director in terms of education of medical staff, coordination of medical care, collaborating with other disciplines, and ensuring regulatory compliance. A key aspect of citations for F-tag 501 is that the medical director regulation can only be cited in the context of other federal tags. In other words, in order to cite the medical director, there must be a deficiency in another area, such as pressure ulcers, nutrition, hydration, pharmacy, etc. This is a key point, as the medical director and physician staff are now tied directly into all aspects of quality of care.

Clinical Example:
Mrs. Jones was an 87-year-old resident of Shady Rest Nursing Home. Her problems included dementia, dysphagia, gastrostomy tube, and contractures of the lower extremities. On July 3, 2005, the nurses noted a stage 3 pressure ulcer on her buttocks. The nurses attempted to notify the primary care physician, but could not because she was on vacation, and the designated coverage physician did not return calls. Treatment orders were not obtained until July 17, when the physician returned from vacation and visited the facility during monthly rounds. During a state survey in August 2005, a surveyor discovered the two-week delay from time of detection of Mrs. Jones’ ulcer to administration of treatment.

How the Regulations Apply:
With this finding, the surveyor can perform an expanded investigation of the facility’s care of pressure ulcers. Using chart review, interviews with staff, quality assurance documents, and dressing observations, this facility may be cited for “Quality of Care, 483.25, Pressure ulcers,” under F-tag 314. Other F-tag citations can be identified related to pressure ulcers such as Resident Assessment (F274), Nutrition (F325), Hydration (F327), and Continence Care (F315). The surveyor can also pursue the Investigative Protocol for medical directors.

This Investigative Protocol will begin by determining whether the facility has designated a licensed physician to serve as medical director. Then the surveyor will determine whether the medical director has collaborated with the facility to coordinate medical care and implement resident care policies with regard to pressure ulcers.

The medical director is subject to interview on topics of resident care policies, medical care, and physician issues related to skin ulcers. His/her role can be examined with regard to actual input on policies and procedures, guidance and/or oversight of primary care physicians, education of physicians regarding skin care, and maintaining adequate physician coverage including availability of consultants. The medical director can be asked how information on quality of care is disseminated to the primary care physicians. The interaction of the medical director with administration can be investigated, specifically how the medical director exchanges information regarding resident care issues.

Interview of the medical director may be supplemented by interviews with other administrative staff, families, and primary care physicians. If the surveyor decides there was noncompliance on the part of the medical director, the survey team must identify the association with the original deficiency (ie, pressure ulcers). Once this association is made, the facility will be cited for F501, and the deficiency categorized with respect to level of harm, also termed Severity Determination.

Key elements for severity determination for F-tag 501 include: (1) presence of, or potential for, negative outcomes; (2) degree of harm (actual or potential) related to noncompliance; and (3) immediacy of correction required.⁵ In our clinical example, if it is determined that actual harm resulted from lack of physician coverage with late medical assessment and treatment of pressure ulcers, and the medical director did not have adequate input regarding physician supervision and wound care, and this problem was widespread throughout the facility, the facility will risk receiving a Severity Level 4 citation, “Immediate Jeopardy.” This categorization will apply to “F314, Pressure Ulcers,” “F501, Medical Director,” and any related F-tag the surveyor deems appropriate.

RECOMMENDATIONS TO ACHIEVE REGULATORY COMPLIANCE

The new guideline for F-tag 501 elevates the nursing home medical director position to one of greater visibility and responsibility. It therefore codifies recommendations that have been suggested for years by physicians advocating improved quality of care in nursing homes, as well as the American Medical Directors Association.^6,7 The first major prerequisite for achieving regulatory compliance for medical directors is adequate on-site presence.

On-site presence should occur during the day shift on weekdays, when key staff are in the facility. Physicians with busy practices who can only show up in early morning hours, evenings, and weekends will have difficulty achieving the goals set forth in the guidelines for F501. Efforts should be made to maintain a working rapport with key staff, such as the administrator and director of nursing. In addition, the medical director must make efforts to maintain accountability and professionalism for both primary care physicians and consultants.⁸

Input into resident care policies is an important component of the guideline. One example of how the medical director can provide input is in the area of ordering laboratory tests. Items such as monitoring warfarin, checking digoxin levels, or checking electrolytes for persons taking diuretics all may require written policies for medical staff. Additional considerations include physician notification of abnormal results, sign-off after review, and timeliness of filling in the resident’s chart.

There are no specific federal recommendations for medical staff meetings, but a quarterly meeting with all physicians, physician assistants, and nurse practitioners is advised. This meeting should have a written agenda that goes over quality assurance (QA) statistics, such as pressure ulcer prevalence and falls. An educational component should present such items as federal regulations, new ulcer documentation procedures, coverage and “on call” schedules, quality and completeness of medical notes, and the like. The medical director should maintain files on each physician and physician consultant that contain credentialing information and pertinent memoranda.

The medical director will need to demonstrate to the surveyor that clinical concerns that affect resident care are evaluated and addressed. He/she should be on the alert for potential abuses of the system by providers. This may include not seeing patients in a timely manner, incomplete or illegible medical notes, unnecessary procedures or visits, overuse of psychotropic medication, and polypharmacy. Communications with physicians regarding these issues should be recorded and maintained in their personnel folder.

The medical director should be available for emergency calls when there are coverage issues and other crises. This may entail opening up communication by promoting approachability by nurse managers. When the state surveyors arrive during a regular survey or complaint investigation, the medical director should be present in the facility and available for questions.

BARRIERS TO REGULATORY COMPLIANCE

A major barrier to regulatory compliance for “F501, Medical Director” is maintaining appropriate reimbursement to the person taking this position. Following implementation of the Nursing Home Reform Amendments in 1990, and prior to implementation of revised F501 in November 2005, medical directors were frequently given modest stipends. The requirements of the position were proportionately minimal, allowing the facility to claim “paper compliance.” This arrangement is certainly no longer conducive to satisfying the federal regulatory requirement for medical directors, who must spend increased on-site time and demonstrate collaboration and leadership.

Another barrier to regulatory compliance is lack of physician training in such critical spheres as geriatric medicine, team dynamics, the regulatory process, and leadership skills. Lack of proper training in geriatrics is widespread, and the current rate of certification in geriatric medicine will not meet current demand.⁹ Gladly, there are excellent continuing medical education (CME) resources available for physicians interested in improving their skills in medical direction. The American Medical Directors Association has developed an extensive education and resource network for medical director education.⁶ In addition, the American Geriatrics Society meetings provide outstanding educational resources.

Finally, the nursing home industry must rise to support the proper level of physician professionalism to achieve the new expectations of regulatory compliance. There must be administrative support for the medical director in terms of salary and resources to maintain levels of quality expected under the new guideline.⁴ The medical director must enter this position with the confidence that his/her input will be respected and appreciated. The federal government now formally recognizes the importance of an informed, involved medical director, and it is time for the nursing home industry to do the same.