QUESTION:    I understand that our patients can now directly obtain their lab results from the lab, and don’t have to get that information from their physician or his or her office. I’m very concerned with my patients receiving those test reports without the benefit of my description and interpretation of them. I don’t know how patients are going to have the knowledge to understand what they’ll be reading, and that could be harmful to them. What is this all about?

ANSWER:    Until this year, the Clinical Laboratory Improvement Amendments (“CLIA”) did not allow a patient to directly access his or her completed test reports. At the same time, while HIPAA championed an individual’s direct access to medical record information, the Privacy Rule said not for lab reports, to be in step with CLIA.

A new federal rule changes all of that. By the new rule, both the CLIA and HIPAA regulations have been revised to allow a patient, or his or her personal representative, to have the right of direct access to the lab results.

As to why this was done, the Department of Health and Human Services (“HHS”) states that it “believes that this right is crucial to provide individuals with vital information to empower them to better manage their health and take action to prevent and control disease. In addition, removing barriers in this area supports the commitments and goals of the Secretary of the Department of Health and Human Services…and the Administrator of CMS regarding personalized medicine, an individual’s active involvement in his or her own health care, and the widespread adoption of EHRs [electronic health records] by 2014.”

As to the concern that patients will not be able to understand the lab results without their physicians’ involvement, HHS states: “This rule does not diminish the role of the health care provider in interpreting the laboratory test reports for his/her patient in the context of the patient’s medical condition. We expect that individuals will continue to obtain their test reports and the interpretation of those test reports from their health care provider.”

HHS also believes: “that the rule will further encourage ordering and treating providers to more proactively discuss with patients the range of possible test results and what the results may mean for the particular patient before or at the time the test is ordered.”

The new rule does not require the testing lab to provide any interpretation information or material to the patient involved.

The world of medical records is changing, and that’s not just because of the switch to EHRs or providers desire to meet the meaningful use rules in order to receive the incentive payments that come with that. Collectively, recent industry practices, rules or rules in the making make patient access more direct (patient portals, this new rule), enhancing patients’ rights. Others treat or propose to treat EHR as less private than they are now (proposed revisions to the federal drug and alcohol medical records laws, practices necessary for health information exchanges to best perform).

These changes are not all pulling in the same direction, and there are likely more changes to come. Look for a coming article in our Action Kit of Hospital Law publications to read more in-depth about all of these changes and what you should know to best manage them.

QUESTION:   We understand that the enforceability of a restrictive covenant depends on state law. In our state, the courts will enforce a covenant in an acquisition and will generally enforce a covenant in an employment agreement. However, a question has arisen as to whether the courts will enforce a covenant in an agreement with an independent contractor in the same manner as it would if the physician were an employee.

ANSWER:   As you correctly point out, whether a court will enforce any type of restrictive covenant depends on your state law. Most (if not all) states will enforce a restrictive covenant that is part of an acquisition of a business. Most states will also enforce a covenant that is reasonable in scope and geographic extent during the term of employment or during the term of an agreement with an independent contractor. Where courts differ is whether a court will enforce a restrictive covenant following the termination of the employment/services agreement. However, the enforceability of a covenant should not depend on whether a physician is an employee or an independent contractor.

In Pennsylvania, for example, the Pennsylvania Superior Court has specifically held that restrictive covenants are applicable “beyond the tradition employer/employee relationship” and has held that “a valid restrictive covenant can be imposed on an independent contractor…restrictive covenants should not be set aside…merely because [a party]…is an independent contractor rather than an employee.” This decision was based on a Pennsylvania Supreme Court decision that a restrictive covenant in a franchise relationship was enforceable and Section 516(f) of the First Restatement of Contracts upholding a restrictive covenant by “an assistant, servant or agent not to compete with his employer or principal during the term of the employment, or agency or thereafter….” (Emphasis added.)

Therefore, the fact that a physician is an independent contractor should have no effect on the validity or the enforceability of an otherwise valid and enforceable restrictive covenant.

 

QUESTION:    Our hospital would like to allow students from local high schools, colleges or trade schools to “shadow” Medical Staff members and other health care professionals. We believe this will encourage students to enter the health professions and perhaps work at our hospital in the future. Would a job shadowing program violate HIPAA?

ANSWER:    The HIPAA Privacy Rule has been in effect for over a decade. In that time, the federal government has not provided any formal or informal guidance regarding job shadowing programs. Also, we have not heard of any HIPAA investigations involving job shadowing programs. This is not to minimize the compliance issues associated with job shadowing programs. However, the government’s lack of action in this area suggests that the HIPAA risks of job shadowing programs can be successfully addressed.

The HIPAA Privacy Rule permits protected health information to be used and disclosed without patient authorization for the “health care operations” of a hospital. The definition of “health care operations” includes two provisions which could reasonably be viewed as including job shadowing programs:

(1)        “general administrative activities” of the hospital; and

(2)        “conducting training programs in which students, trainees, or practitioners in areas of health care learn under supervision to practice or improve their skills as health care providers.”

We believe that job shadowing programs could be viewed as part of the “general administrative activities” of the hospital. Such programs can increase the number of individuals interested in health careers and allow hospitals to build closer relationships with their communities. These would seem to qualify as important administrative activities of a hospital.

Another alternative is for a hospital to establish a “Health Career Assessment and Training Program” in a formal manner. The purpose of such a program would be to encourage individuals to choose health care professions as careers. This would bolster the argument that participants in the training program fall within the training language set forth in the Privacy Rule’s definition of health care operations.

To minimize risk, job shadowing programs could require that students sign an agreement by which they promise to keep the identity of any hospital patient and the medical condition or treatment of any patient strictly confidential. In addition, a sponsor from the hospital, either a physician or other health care worker, should sign an agreement to be responsible for the actions of the student.

QUESTION:    This week’s question comes from Jack, who lives in Georgia, and who writes “Dear Countdown, my wife, Diane, has lived far away from me for the past several years as she went through residency.  It’s been very hard, but now things are looking up, since she’ll soon be taking the Midnight Train to Georgia and be with me again.  I’m wondering though – I’m on the Medical Executive Committee of a hospital, and Diane is going to apply for clinical privileges there.  I was told that I can’t vote on her application, but my thinking is What’s Love Got to Do with It?”

ANSWER:    Well, Jack, we don’t want you to be Alone Again (Naturally).  But in order for this story to have a happy ending, you’ll need to think back to your compliance training and Listen to What the Man Said about basic conflict of interest rules.  You see, you have, or reasonably could be perceived as having, a conflict of interest or bias regarding Diane’s application.  So, you can’t participate in the final discussion or vote on her application, and are required to be excused from the meeting during that time.  But, you may provide relevant information and answer any questions regarding her application before leaving.  Good luck Jack & Diane, and the Countdown wishes both of you Endless Love.

QUESTION:    The MEC and Board serve as approval-type bodies for credentialing decisions.  So, our custom is to have the chair of each department present applicants within their departments to the MEC for approval.  Usually, this just involves the department chair offering up a list of applicants who have been “recommended” for appointment, reappointment, and clinical privileges.

At the Board level, the MEC’s recommendations for appointment, reappointment, and clinical privileges are presented.  This generally involves the Board being given a list of applicants and the Chief of Staff verbally reporting that the MEC has recommended the listed individuals.

Is something more required or recommended?

ANSWER:    When hospitals credential applicants for appointment, reappointment, or clinical privileges, much of the hard work is done by the Medical Staff Office and Credentials Committee, which look closely at any history that the applicant may have, follow up on any concerns, and obtain more information from the applicant and outside resources, and, in the case of the Credentials Committee, carefully deliberates and decides how to proceed.  While these functions are invaluable to the credentialing process, they do not replace the important role that the MEC and Board play in carefully considering and acting upon applications for appointment, reappointment and clinical privileges.

When no concerns have been raised about an applicant (which is the case most of the time), the MEC and Board can likely fulfill their duties by approving a list of applicants, with the understanding that the Medical Staff Office, department chairs, and Credentials Committee have done their jobs diligently, in accordance with the Medical Staff Bylaws and related policies.

The situation differs when material concerns have been raised about an applicant.  In that case, the MEC and Board should be provided more information about the concerns and the reasons for the recommendations of the department chair and/or Credentials Committee – even if the department chair and Credentials Committee have decided to recommend appointment or reappointment and the grant of clinical privileges, with no additional conditions or restrictions being put into place.

It can be helpful in emphasizing the Board’s responsibility for approving applicants for the Board Chair to require that the Chair of the Credentials Committee or the Chief of Staff personally present the approved list of applicants for Board approval.  The Board Chair would – each time – ask the presenter whether he or she personally approved the actions.  This all is pro forma but it emphasizes that the Board expects that those who send the list forward for Board approval understand the Board’s responsibility and accept responsibility for the recommendations they are making.

After being alerted to the general nature of the concerns involving the applicant, the MEC or Board (as applicable) can decide whether it would like to review the applicant’s credentials file, obtain additional information, or refer the matter back to the Credentials Committee for further consideration and recommendation.  Those bodies can only make such decisions, however, if they are made aware that there is something unusual about the applicant who is before them for approval.

So, the answer to your question is that, yes, when making credentialing decisions, it is sometimes necessary for the MEC and Board to be given more than a name on a list.

Please join us at The Credentialing Clinic this fall for more practical advice and tips for leaders performing credentialing functions.

Question:        How many people would be ideal to participate in a collegial intervention and do you recommend that an administrative staff person sit in to take notes in order to prepare the follow-up paperwork?

ANSWER:        While there is no hard and fast rule, it generally is a good idea to have more than one person.  Two or three are usually best.  If there are more than three, it can put the person who is being “intervened upon” in a very defensive posture and is likely not to be helpful.

The same applies to having a person sit in to take notes.  When the whole tenor of the conversation is that this is a confidential discussion among colleagues, it can seem disingenuous and be disconcerting to have someone sit in to take notes.  However, often the support person has more experience in participating in collegial interventions than the leaders do because they rotate in and out of leadership positions, so sometimes it may be helpful.

It is not always possible, but we recommend drafting the follow-up letter that will be sent after the collegial intervention BEFORE the intervention takes place.  The process of writing the letter can help leaders plan for the intervention, determine their talking points and outline the changes in practice or behavior they would like to see going forward.  Of course, the letter should be modified to reflect the actual conversation before it is sent.

If you missed our webinar, Collegial Intervention:  Awkward and Uncomfortable – but Effective!, you can still obtain a recording of the webinar and all of its supporting documents, including:

• Collegial intervention checklist to track the major issues that must be addressed in any effective collegial intervention, from planning to follow-up;
•  Template follow-up letter to collegial intervention that ensures the meeting is documented in a way that helps the physician under review, facilitates future interventions if they are necessary, and also protects the physician leader if the need arises;
• Policy on Practitioner Access to Confidential Files that grants Medical Staff members access to the various different types of information about them in their files – but in an appropriate manner;
• Confidentiality and Non-Retaliation Agreement that helps to preserve the peer review privilege for confidential information and files – and prevent retaliation against individuals who may have reported a concern; and
• Slides used during the webinar.

QUESTION:    As we continue to employ more physicians, we have spent a fair amount of time trying to manage the files related to these individuals. At this point in time, “personnel files” live in our HR department, while our confidential medical staff files live in the Medical Staff Services Department.  But where should we keep the health records of employed physicians when there has been a disclosure of a condition like Parkinson’s or ADHD?

ANSWER:    The Americans with Disabilities Act (“ADA”) places certain restrictions on the manner in which employee health information may be stored.  The regulations implementing the ADA state that such information must be stored in a confidential manner that is only accessible by supervisory personnel and first aid workers.  This approach is explained in the Equal Employment Opportunity Commission’s (“EEOC”) guidelines, which state that:

The ADA requires employers to treat any medical information obtained from a disability?related inquiry or medical examination (including medical information from voluntary health or wellness programs), as well as any medical information voluntarily disclosed by an employee, as a confidential medical record. Employers may share such information only in limited circumstances with supervisors, managers, first aid and safety personnel, and government officials investigating compliance with the ADA.

Accordingly, whenever information related to an employed physician’s health is disclosed, there is no hard and fast rule on where the information is physically stored.  The primary concern is limiting the accessibility of that information to those who have a “need to know,” i.e., a supervisor or manager who may be involved in developing any necessary accommodations related to the employee.

For answers to more of your credentialing questions, including tips on how best to organize and maintain access to your confidential files, please join us this fall for “The Credentialing Clinic” at the New York Marriott Marquis in The Big Apple or contact us about having The Credentialing Clinic come to you!

QUESTION:    We are a rural hospital that has difficulty recruiting physicians for certain specialties.  To help with recruitment, we are actively seeking to engage physician recruiters to bring needed physicians to our hospital.  The physician recruiters that would like to work with us all have proposed different contractual terms for their services.  What should we be looking for or insist on including in these agreements with the physician recruiters?

ANSWER:    Some physician recruiters will offer bare bones recruitment agreements and “guarantee” a physician’s placement for a limited period of time, such as 30 days.  We recommend, at a minimum, a stronger “guarantee” in any agreement with a physician recruiter.  For example, the agreement should specify that if a physician candidate for whom the recruiter has been paid fails to commence a medical practice per the employment agreement or if the employment agreement is for any reason terminated within one year of the commencement date, then the recruiter will conduct a new search at no additional fee for a period of six months to provide a suitable replacement candidate.  If the recruiter fails to provide a replacement candidate, the agreement should obligate the recruiter to refund the fee paid for its recruitment efforts.

In the Simpson v. Beaver Dam Cmty. Hosp., Inc. case, the employer paid the physician recruiter $12,000 after the physician accepted the offer of employment even though the credentialing process for medical staff appointment and clinical privileges was not complete.  Ultimately, the physician was not appointed to the medical staff or granted clinical privileges and his employment did not go forward.  Using a strong “guarantee” in agreements with physician recruiters can help eliminate situations like these when the employer, per an unfavorable agreement, would otherwise be on the hook for a significant sum because of the recruitment of an unsuitable candidate.

We also recommend that the agreement include a “position description” attachment, which the recruiter will provide to the candidate.  The position description outlines the duties and obligations that will be set forth in the employment agreement.  The position description serves the primary purpose of informing both the recruiter and the candidate of the expectations for employment.  Ideally, outlining these in a position description and requiring the recruiter to present it to any candidate will minimize the chances that the recruiter will present candidates who are unable to meet the expectations and will also save both time and money for the employer.

For more information on physician recruitment and other essential topics related to physician employment, please join Henry Casale, Rachel Remaley, and Charles Chulack for the Institute on Employed Physicians and Their Impact on the Medical Staff in New York, New York on December 4-6, 2014.

QUESTION:    We are now reviewing our Bylaws and Credentials Policy.  One physician has objected to the proposed language that the CEO appoints the hearing panel.  Is it okay for us to keep the current provision that the Chief of Staff appoints the hearing panel?  We haven’t had a hearing in over a decade.

ANSWER:    A hearing panel is most commonly appointed by the CEO, to protect the Chief of Staff from the risk of being named in a suit.  Such a suit can include antitrust claims that there is a conspiracy to restrain trade, among medical staff members.  Hearings are rare.  The Bylaws or Credentials Policy should guide physician leaders to use progressive steps starting with collegial intervention.  A Peer Review Policy should provide options for performance improvement plans.  However, a hearing is necessary when an adverse recommendation is made by the MEC, in cases where a practitioner is unable or unwilling to follow those steps.  Often, the attorney for the affected practitioner will seek to argue that medical staff leaders are biased or acting anticompetitively. The Health Care Quality Improvement Act immunity has worked well to protect physician leaders from antitrust allegations that were common before the HCQIA.  The HCQIA’s objective reasonableness standards have been applied by the courts generally to rule that allegations of subjective motives are irrelevant if the record demonstrates reasonableness. The Chief of Staff is at some risk of being personally named in an antitrust suit – an aggravation even if the likelihood of actual liability is extremely remote.  However, notwithstanding the enhanced legal protection for the Chief, it can sometimes be politically difficult to get buy-in for the CEO to appoint the panel.  A middle ground, to balance trust and protection, is to have the CEO consult with the Chief of Staff. 

QUESTION:    We have several clinical departments that have either weak chairs or chairs who are there entirely by “default.” These individuals are relied upon to perform a really important role.  How can we get stronger leaders interested?

ANSWER:    In many hospitals, it has been traditional to rotate the department chair position so that everyone in the department gets his or her turn.  However, not every physician has an aptitude for, or interest in, medical staff leadership.  And to be perfectly honest, many do not even know what the role will require of them before they assume the position.  One answer may be to develop stronger qualifications for serving in medical staff leadership roles, including officers and department chairs, and to provide compensation for department chairs.  Another question to ask is if there are too many departments.  Consider including guidelines in the governance documents that provide factors for the medical executive committee to consider when deciding whether to eliminate (or establish) clinical departments that explains the functions that the individuals within such a department have to fulfill.  On that basis, you might consider consolidating departments or doing what many hospitals have done, which is moving to a service line model.  By having fewer positions to fill, you then have a larger pool of qualified people who want to serve!