QUESTION:      Our state, probably like most, requires a criminal background check. Our employed physician group has hired a badly needed primary care physician to serve in one of our more rural clinics. When his application was submitted for medical staff appointment, the report of the background check stopped the process cold. It listed arrest for “minor” infractions, such as assault and disorderly conduct.

The employer insists that the physician’s application be processed timely, as he was scheduled to start in the clinic on January 1. The medical staff process requires that we follow up on unusual information in an application. The applicant is claiming that the hospital is “interfering with his contractual relationship.” This has exacerbated the rift between HR and the medical staff. I thought we were all on the same team? What now?

ANSWER:     With notable exceptions to be sure, the HR/medical staff disconnect, when it comes to employed physicians, has been more perplexing than it needs to be. Medical staff professionals and physician leadership are increasingly very well trained credentialers. They “get it” that credentialing is a duty owed to the patient – to assure that those who are selected to practice in the organization are well qualified to do so safely and competently. They know how to follow up on unusual or problematic questions, circumstances or blanks in an applicant’s background. Their mantra is “the burden is always on the applicant” to demonstrate that he or she qualifies.

Issues such as yours require follow-up, to determine if the arrest was the result of one awful and regretted event or a manifestation of a larger problem.   In addition to the duty to the patient, the medical staff and leadership know very well that there is also a duty to treat the applicant fairly. In this case, that might involve requiring the applicant to provide a complete explanation and documentation of the incident for further assessment.

Some employers of physicians have not caught up to this duty and process. They often have different objectives, such as making sure the clinic is staffed timely.

This is an easy fix, except when you are in the middle of it. The necessary process is that the recruiters, those who hire in the employed physician group and HR must have access to the same excellent education your medical staff professionals have. The “threshold qualifications” for employment and appointment must be coordinated. The employed physician group and HR may create a structure, whether a CVO or some other contractual relationship, to employ the expertise of the Medical Staff Office in the assessment of applicants.

Employment itself never qualifies a physician for medical staff appointment or clinical privileges. Ever.

QUESTION:     Can our hospital’s Institutional Review Board (“IRB”) be structured like and function as a medical staff committee?

ANSWER:     No. The federal Food and Drug Administration regulations pertaining to IRBs, 21 C.F.R. §56.101 et seq., define an IRB as “any board, committee, or other group formally designated by an institution to review, to approve the initiation of and to conduct periodic review of biomedical research involving human subjects.” The Department of Health and Human Services’ regulations echo the “institutional” aspect of the formal designation of IRBs (45 C.F.R. Part 46). Federal regulations require the IRB to be a committee formally designated by a hospital’s Governing Board to review biomedical research involving human subjects at the hospital.

This issue has been gaining momentum lately in research audits performed by both the Office of Human Research Protections and the Food and Drug Administration in which the agency takes issue with the fact that the institutions included their IRBs as one of several “medical staff committees” that lived in a medical staff governance document like the bylaws. The auditors pointed generally to the language cited above, that it is an institutional responsibility to maintain an appropriate IRB, not a medical staff responsibility. As a practical matter, the concern is that (however unlikely) if the IRB procedures need to be revised because of a regulatory change, the medical staff may refuse to do so, as is contemplated by the amendment process to these rules. By comparison, if the IRB is a hospital committee, hospital administration and/or the Board could implement a change on its own action. Again, while the likelihood of a Medical Executive Committee or a medical staff as a whole acting in such an obstructionist manner is very slim, in the eyes of the audit agencies, it is a valid concern.

Therefore, we recommend that the IRB be created by a Board resolution and thereafter function as a committee of the hospital, rather than the medical staff, with its independent authority derived from the Board. For this reason, a medical staff committee should not act as the IRB. There may be substantial overlap of the IRB membership with that of a medical staff committee. However, the IRB should be constituted as a separate committee of the Board in accordance with the membership requirements set forth in the federal regulations.

QUESTION:    We would like a hospital employee to obtain a daily list of admissions, review the patient’s medical record to determine if the patient might benefit from rehab services offered by the hospital, and contact the patient if rehab is indicated. Is this permitted, or would it violate HIPAA’s “marketing” rules?

ANSWER:    This practice would be permitted by HIPAA. Under HIPAA, “marketing” means “to make a communication about a product or service that encourages recipients of the communication to purchase or use the product or service.”

However, HIPAA includes a number of exceptions to this definition of marketing. Under HIPAA, the following activities are not “marketing” (as long as payment is not made to the entity for making the communication):

1. “case management or care coordination for the individual, or to direct or recommend alternative treatments, therapies, health care providers, or settings of care to the individual”;

2. “to describe a health-related product or service (or payment for such product or service) that is provided by, or included in a plan of benefits of, the covered entity making the communication”; or

3. “case management or care coordination, contacting of individuals with information about treatment alternatives, and related functions to the extent these activities do not fall within the definition of treatment.”

Calling a patient to discuss the rehab services offered by the hospital satisfies the exception to the definition of marketing. Thus, such calls would not violate HIPAA.

QUESTION:        Our state law says that employers may not make hiring decisions based on criminal convictions unrelated to the employee’s suitability for a particular job. What makes a person suitable for practicing medicine?

ANSWER:        There is not a single, fully-accepted answer to your question. Accordingly, in order to comply with your state law, you will have to use your professional judgment to define the types of crimes that are related to practicing medicine.

At least one court has held that conviction of any felony is a legitimate consideration when looking at the qualifications of a physician for Medical Staff appointment or clinical privileges (See Bouquett v. St. Elizabeth Corp. (Ohio 1989), holding that the “best interest of patient care encompasses more than technical skills and professional competence. It includes the perceived integrity of the physician which becomes suspect after he has been convicted of a felony.”) But, that case was not decided recently and with the passage of time may have lost a bit of its persuasive authority, especially since the modern trend is to more significantly limit the consideration of criminal background.

A number of health care organizations have begun to think through the issue of job?related crimes – and, in assisting them, we have come up with a short list of criminal activity that is pretty obviously related to the practice of medicine:

• crimes related to violation of the state’s medical practice statute
• crimes related to possession or distribution of controlled substances
• insurance or health care fraud and abuse
• violence
• sexual assault
• abuse of a member of a vulnerable population (child abuse, elder abuse, etc.)

Some employers choose to limit consideration of criminal activity temporally (a practice that is strongly encouraged by the EEOC). For example, you may choose to consider only those crimes occurring in “the past 7 years” or “since the commencement of medical training.” Of course, you should work with your counsel to ensure that any time frame you choose is consistent with your state’s laws.

Finally, also consider incorporating mitigating factors into any examination of an applicant’s criminal background. For example, while a conviction or plea of guilty or no contest might result in automatic elimination from consideration with respect to some crimes, for other crimes, you might examine the circumstances of the crime on a case-by-case basis, along with the following factors:

• The nature of the conviction
• How closely the actions of the applicant, with respect to the crime, bear on his or her ability to safely practice medicine
• The time elapsed since the conviction
• The applicant’s age at the time of conviction
• Evidence that the applicant has rehabilitated himself or herself
• Evidence that the applicant has been practicing medicine since the conviction, without additional incident

For more details on employment trends affecting physician employment and hospital?physician relations, please join us January 15-17 for the Institute on Employed Physicians and Their Impact on the Medical Staff. We will discuss criminal background checks, the EEOC’s guidance on how to lawfully consider criminal background during the hiring process, and many other interesting issues. Consult the brochure for more information about the program.

QUESTION:    In the January 2, 2014 Question of the Week, you discussed the Bundled Payments for Care Improvement initiative, which was developed by the CMS Innovation Center. In Model 2, the participants were “live” and in the risk-bearing period (“Phase 2” – actual expenditures on beneficiaries were reconciled against a “target price” for an episode of care – if a participant was under the target price for a beneficiary, it kept the difference, but if over the target price, pays the difference to CMS). Can you update us on Model 2, Phase 2?

ANSWER:    Yes. In November, CMS announced that it would eliminate downside financial risk for 2014 for all participants in Phase II because of complications associated with launching BPCI. The elimination of downside financial risk means that hospitals will not have to pay back CMS for losses, nor will hospitals have any financial liability for the rest of 2014. However, hospitals will still be able to earn gains if their aggregate spending falls below the aggregate target price amounts during 2014. However, as of the first quarter of 2015, all BPCI participants in Phase 2 will face full downside risk.

QUESTION:      We’ve had some debate over who can order therapeutic diets. Can you help explain the rules on this issue?

ANSWER:      Historically, CMS has restricted the ability to order therapeutic diets to “practitioners responsible for the care of the patient.” This generally meant physicians. However, in its Final Rule dated May 12, 2014, CMS changed its position on this matter, and revised 42 C.F.R. §482.28(b)(2) to read “All patient diets, including therapeutic diets, must be ordered by a practitioner responsible for the care of the patient, or by a qualified dietician or qualified nutrition professional as authorized by the medical staff and in accordance with State law governing dieticians and nutrition professionals.” (Emphasis added.)

This change came about largely in recognition of the fact that registered dietitians are trained to order patient diets independently, without requiring the approval or supervision of a physician. In order to give hospitals more flexibility in this area, CMS noted that “[i]n order for patients to have access to the timely nutritional care that can be provided by [registered dieticians], a hospital must have the regulatory flexibility either to appoint [registered dieticians] to the medical staff and grant them specific nutritional ordering privileges or to authorize the ordering privileges without appointment to the medical staff, all through the hospital’s appropriate medical staff rules, regulations, and bylaws.”

While it is unlikely most medical staffs would elect to make dieticians full members, CMS does indicate that in order for a dietician to order patient diets independently, clinical privileges must be granted and monitored by the medical staff.

Of course, your state law may still limit a dietician’s scope of practice, so be aware of any restrictions at the state law level.

For answers to more of your credentialing and privileging questions — including those related to allied health professionals — please join us for The Credentialing Clinic or contact us about having The Credentialing Clinic come to you!

 

QUESTION:    Nationally, what are you seeing with regard to the composition and structure of Medical Executive Committees and what is the national norm regarding term limits for Department Chairs?

ANSWER:    In many hospitals, the Medical Executive Committee (“MEC”) has become unwieldy and ineffective. One trend we are seeing is an effort to re-engineer the MEC and reduce the number of physician members and hospital/administrative representatives. The goal is to create a more nimble, effective body that can respond promptly to the challenges facing the Medical Staff and the Hospital, and also be a forum for thoughtful discussion, planning, and action.

Seven to nine members is considered by many leadership gurus to be the “best practice”/optimum size for leadership committees and professional boards in order to conduct efficient operations and promote thoughtful discussion and action. An article in the Harvard Business Review observed that research on group dynamics indicates that, in larger groups, members “cease to take personal responsibility for the group’s actions and rely on others to take the lead.” Large groups also “inhibit consensus building.”

As another trend, the “agendas” for MEC meetings are being re-evaluated to be sure that the issues that truly need discussion and planning take precedence over the important – but more “routine” and ongoing – agenda items that appear each month. Consent agendas are definitely on the rise!

Finally, we are seeing that many MECs (and all Medical Staff committees really) benefit from having the expectations and requirements for committee service explicitly articulated and shared with the committee members, prior to their service. While many of the principles are common sense, we are finding that making them explicit helps MECs (and other committees) function better.

The most common “term of service” we are seeing nationally for Department Chairs is still two years and reappointment for additional terms is generally permitted. But increasingly, the initial term is lengthened to three years in order to permit more leadership development and effective functioning.

In many hospitals, Department Chairs are no longer elected by members of the Department. Rather, there is  a “Nominating/Leadership Development Committee” that is responsible for not only nominating candidates for Medical Staff office, but also selecting committee chairs and members and Department Chairs, after obtaining feedback from others. This requires a lot of education with the Medical Staff, but this model has proven to be very effective in improving the quality of overall Medical Staff leadership.

QUESTION:    Our hospital uses a team of hospitalists who provide care for all internal medicine admissions. This has been a successful program; quality of patient care and patient satisfaction have markedly increased. The problem is that now we have a number of internists appointed to the medical staff who very rarely, if ever, come to the hospital, however they still have clinical privileges. This brings up problems during reappointment in being able to assess current clinical competence. Any solutions?

ANSWER:    Reappointment, when it includes the renewal of clinical privileges, is to be a “performance-based reappraisal,” which does become harder if you have little clinical data. If an internist is appointed at another hospital, you can request the physician’s quality file from a hospital where he or she is more active, obtain peer evaluations that incorporate the six ACGME general competencies from physicians to whom referrals are made (including the hospitalists), and also, possibly, seek managed care quality profiles. You could request office records from the physician to review as well, although not many medical staffs seem to take that approach because of how onerous it is for a physician who no longer provides services at the hospital.

The approach that many medical staffs and hospitals have taken in the recent past is having a staff category that does not include clinical privileges – Ambulatory Care Staff or Community-Based Staff – which includes perks like being able to access patients’ electronic records and being able to have office H&Ps entered into the record, while not granting clinical privileges which gets the hospital off the hook for performing OPPE, FPPE and needing to assess clinical data at reappointment.  Because so many physicians are transitioning to such staff categories from the Active Staff due to changes in clinical practice patterns, we are also seeing a move towards permitting these individuals to vote and serve in leadership roles as part of the desire to keep them connected to the hospital.

 

Question:    Under the Americans with Disabilities Act (“ADA”), are we permitted to disclose information about the disability of a physician previously employed by us in response to a reference request from a prospective employer that seeks information on the ability of the physician to perform the functions of his anticipated position?

Answer:    If the information about the physician’s disability was obtained through a “medical examination or inquiry,” the answer is “no.” Under the ADA, any information obtained regarding the medical condition or history of an employee as a result of a “medical examination” or “medical inquiry” must be “collected and maintained on separate forms and in separate medical files and is treated as a confidential medical record.”

This statutory rule contains several exceptions which permit disclosures of the information to: (1) supervisors and managers regarding necessary restrictions on the work or duties of the employee and necessary accommodations; (2) first aid and safety personnel, when appropriate, if the disability could require emergency treatment; and (3) government officials investigating compliance with the ADA. However, none of the exceptions encompass disclosure of information obtained through a medical examination or inquiry on an ex-employee’s disability in response to a reference request.

At least one court has concluded that information about an ex-employee’s health disclosed in response to a reference request was not a violation of the ADA if the information was not obtained through a medical examination or inquiry. In EEOC v. Thrivent Financial for Lutherans, the United States Court of Appeals for the Seventh Circuit found that an employer did not violate the ADA by informing a prospective employer that the ex-employee suffered from migraine headaches. This information was obtained when the former employer contacted the ex-employee after he failed to show up for work and did not notify anyone. The court concluded that the contact was not a “medical inquiry.” As such, the information obtained about the ex-employee’s migraine headaches was not subject to the confidentiality provisions of the ADA.

Nonetheless, employers should tread carefully in this area. Other laws may come into play, such as the Health Insurance Portability and Accountability Act (“HIPAA”), especially if the employer is a health care provider and the health information of the employee was obtained during treatment provided by the employer.

For more information on the ADA and effectively managing health issues of employed physicians, please join Henry Casale, Rachel Remaley, and Charles Chulack for the Institute on Employed Physicians and Their Impact on the Medical Staff from December 4 – 6 in New York City, New York.

QUESTION:    One of our older surgeons had several very bad cases right in a row. Medical Staff and Hospital leadership were very concerned and, after a lot of discussion, we decided we could not let the surgeon practice until we had completed a focused review. We asked the surgeon to “agree to refrain from exercising her clinical privileges” while we completed the focused review, but she refused. We then imposed a precautionary suspension. A week later, the surgeon resigned. We had not commenced an investigation so we weren’t sure if we had to report the resignation to the National Practitioner Data Bank (“NPDB”).

 ANSWER:     You are correct in thinking about whether an investigation was started with respect to your reporting obligation to the NPDB. The Health Care Quality Improvement Act (“HCQIA”) imposes an obligation on hospitals to report professional review actions that adversely affect the clinical privileges of a physician for a period of longer than 30 days. The HCQIA also requires a hospital to file a report if it accepts the surrender of clinical privileges “while the physician is being investigated…relating to possible incompetence or improper professional conduct or…in return for not conducting such an investigation.” So, clearly, if the physician had resigned during an investigating or in return for not conducting an investigation, the resignation would have been reportable to the NPDB.

In your situation, even though there was no investigation, the physician’s clinical privileges had been precautionarily suspended. The NPDB Guidebook specifically addresses the reportability of resignations that occur during a suspension. According to E-20 of the Guidebook: “If the physician, dentist, or other health care practitioner surrenders his or her clinical privileges during a summary suspension, that action must be reported to the NPDB.” Therefore, even though the surgeon did not resign during or in lieu of an investigation, the surgeon’s resignation while under a precautionary suspension must be reported to the NPDB. It is also important for you to check state law. You may have a separate obligation to report the resignation under state law.