Question Of The Week

November 19, 2020

Posted on by hortyspringer

QUESTION:        We have an applicant for medical staff appointment who is over 80 years old. Are there certain things we can require during the credentialing process before he gets on staff?

 

ANSWER:           Let’s start with Henry’s favorite answer:  “It depends,” because it always does.

We recommend that Hospital Medical Staffs try to comply with the Americans With Disabilities Act (“ADA”) and Age Discrimination in Employment Act (“ADEA”) in the credentialing and recredentialing processes.  Whether the ADA and ADEA, which are both employment-based statutes, apply to the appointment process is still an open question.  But there are a number of cases, in reviewing these and other civil rights statutes, that have concluded there should be broad application of these laws and have applied them to the credentialing and recredentialing processes.

Furthermore, more and more physicians are employed, and these statutes will apply to your employed physicians.  It makes no sense to have two sets of rules in your credentialing process, one for employed physicians and one for private practice physicians (especially if the standard for private practice physicians is higher).  Therefore, we recommend that hospitals get as close as possible to compliance with the ADA and the ADEA, including in their appointment and reappointment processes.

Under the ADA, an employer is prohibited from requiring a health examination or making health-related inquiries until after a conditional offer of employment.  In the medical staff world, this means there can be no required physical examination and no health status questions until after the Credentials Committee has determined that an applicant is otherwise qualified to practice.

After the conditional offer, the employer is permitted to ask any health status questions and/or require a fitness for practice evaluation so long as it asks the same questions and requires the same evaluation for similarly situated applicants.  In the medical staff world, this means that after the Credentials Committee has made a conditional recommendation for appointment, a physical examination could be required and health status questions could be asked as long as this is the practice for all applicants.

If you do not typically ask health status questions or require a physical exam, you cannot do so just for the 80-year-old applicant.

There is an exception to this rule if a concern about a potential impairment is brought to your attention.  So, for example, if a peer reference raised a concern about the applicant’s cognitive impairment or eyesight or hearing or technical skills in the OR, you could follow-up.  The same would be true if during the interview the applicant was unsteady on his feet or confused.  Under these circumstances you would be permitted to follow-up on the health concerns and you could require a fitness for practice evaluation.

The ADEA would also prohibit you from making an appointment (or reappointment) decision based solely on the physician’s age.  The days of “congratulations on turning 75, you’ve been elevated to the Honorary Staff” are gone – as they should be.  It is worth pointing out that the requirement that a physician get a physical or cognitive exam based on the physician’s age (as some Late Career Practitioner Policies do) is being challenged by the EEOC.  See EEOC v. Yale New Haven Hospital.  https://www.eeoc.gov/newsroom/eeoc-sues-yale-new-haven-hospital-age-and-disability-discrimination.  The challenge is based on both the ADEA and the ADA.

 

November 12, 2020

Posted on by hortyspringer

QUESTION:        The medical staff recently began an investigation of one of our employed physicians.  We have decided to exercise our right to terminate the physician without cause which, per the terms of his employment agreement, will result in the automatic expiration of his medical staff appointment.  Is this reportable?  Is there anything else we should consider?

 

ANSWER:          This situation is not reportable to the Data Bank.  How do we know – the Data Bank told us.  We also have some other recommendations that you should consider.

First, the termination of the Physician’s appointment due to the terms of an agreement is not reportable.  That is true even if the physician is under medical staff investigation at the time of the termination.

When asked about a similar situation, we received the following response and analysis from the Data Bank:

Response:

Regulations and Policies:

Under 45 CFR §60.12(a)(i), “[e]ach health care entity must report to the NPDB…[a]ny professional review action that adversely affects the clinical privileges of a physician or dentist for a period longer than 30 days.”

Under 45 CFR §60.3, a professional review action is “…an action or recommendation of a health care entity; 1) taken in the course of professional review activity; 2) based on the professional competence or professional conduct of an individual health care practitioner which affects or could affect adversely the health or welfare of a patient or patients; and 3) which adversely affects or may adversely affect the clinical privileges or membership in a professional society of the health care practitioner…” Additionally, a professional review activity under 45 CFR §60.3 is “an activity of a health care entity with respect to an individual health care practitioner…[t]o change or modify such privileges.” According to the NPDB Guidebook, the reporting entity generally decides when a professional review has occurred.

According to the NPDB Guidebook, “[a]dministrative actions that do not involve a professional review action should not be reported to the NPDB.”2 This point is illustrated in Q&A#2.3 In Q&A#2, the hospital used its employment termination procedures, not a professional review process, to revoke the practitioner’s clinical privileges. Since the hospital did not take the action through the professional review process, the revocation of the clinical privileges was not reportable.

Analysis:

In this scenario, the facility is terminating its employment arrangement with a physician due to the physician’s past non-compliance. The employment agreement requires that the physician relinquish his or her privileges if requested by the facility. Should the facility report the relinquishment of the privileges? Based on these facts, and similar to Q&A#2, the facility in this scenario is using its employment termination procedures to remove the practitioner’s privileges. Since it is using its employment termination procedures and not its professional review processes to remove the privileges, the relinquishment of the physician’s privileges would not be a reportable action.

(Emphasis added.)

We also have some practical advice for employers everywhere.  When preparing an employment agreement, give some thought to the length of the notice period to terminate the agreement without cause.  This period should be long enough to provide time to find a replacement, but not so long that it will create a financial strain on the employer’s finances if it decides to provide the physician with pay in lieu of working out the notice period (which is common).

While the decision to terminate the employment agreement must be made solely by the employer, the employer should make the medical staff committee involved in the investigation aware of its decision.  Also remind the Committee members that if they receive a request for a recommendation about this physician, they should inform Hospital management of the request.  The Hospital’s medical staff office should then inform the physician requesting the recommendation that no information will be provided without the physician executing a release that is specific to your hospital.

 

November 5, 2020

Posted on by hortyspringer

QUESTION:        I know that the Centers for Medicare and Medicaid Services (“CMS”) have made certain regulatory flexibilities available in response to the public health emergency.  Where is the best place to learn more about these changes?

 

ANSWER:           CMS has made available a large amount of material relating to COVID-19 on its website, but it isn’t always easy to find a specific piece of information (or to know when something’s been recently updated).  Speaking generally, the best starting point for research is the agency’s “Current Emergencies” page, which you can find here.  It’s a bit overwhelming at first, but I would first suggest that you focus on the link that says:  “Get waiver & flexibility information.”  This will take you to a new page that lists “Waivers & flexibilities for health care providers.”  You can skim that list to look for items that may be relevant to your question.  I often scroll down to the “provider-specific fact sheets” when I am beginning my research.

Be careful of relying too heavily on any one document, unless it is crystal clear.  These guidance pages are being updated regularly, and we have encountered numerous situations where the information provided can be misleading or seriously incomplete.  Although it’s not always possible, it’s good if you can locate relevant material from a regulation.

If you have a question about a recent change to a policy, be aware that the agency may not yet have an answer for you.  Under these circumstances, it may be helpful to check this list of CMS podcast transcripts to look for recent updates.  The “CMS Office Hours” calls will often have transcripts that you can search.  (If you have the time, you can also call into one of the agency’s “Office Hours” calls directly.  Agency representatives make themselves available to answer questions related to the Medicare program.)

These online resources can be a helpful way to answer run-of-the-mill questions, but we would encourage you not to rely on them for more important matters.  In those cases, it’s best to seek legal counsel.

October 29, 2020

Posted on by hortyspringer

QUESTION:        I heard on a recent audio conference that nurse practitioners are not permitted to be listed on the emergency department call schedule.  But, it’s commonplace at our Hospital for the hospitalists to split call amongst the doctors and the nurse practitioners.  It’s been this way for years.  Did something change?

 

ANSWER:          The Emergency Medical Treatment and Active Labor Act (“EMTALA”) has always required that a physician be listed on the on-call roster for the emergency department (“ED”). Nurse practitioners, physician assistants, and other non-physicians do not suffice to satisfy this legal requirement.

That does not necessarily mean your hospital has been doing things wrong, however.  When the term “on call” is thrown around by those involved in hospital and medical staff compliance matters, sometimes things get jumbled up a bit – because that term can mean a number of things.

It is perfectly acceptable for nurse practitioners, physician assistants, and other non-physicians to be on call for their private group practice or for their employer (for example, physician assistants who are part of an employed or contracted hospitalist group that covers all patients admitted to the hospital).  These individuals likely are responding to calls about the practice’s patients (sometimes from the ED and sometimes from the floor) and they may even agree to take on some unassigned patients who present to the hospital, if no one else is available to assume those patients’ care.

This is different than the ED’s on-call roster.  The on-call roster is used by the hospital to ensure that services that are designed to meet the needs of the community are available within the ED.  This is the roster of physicians who respond in the event that a patient comes to the ED and is determined to be suffering from an emergency medical condition that requires stabilization.  In some (most) hospitals, if the patient lacks an existing patient-physician relationship with the type of specialist (e.g., cardiology, oral and maxillofacial trauma surgeon) whose services are required, the patient is considered “unassigned” and, by policy, the physician listed on the ED’s on-call roster must respond to the hospital to care for the patient (as requested by the ED physician).  In some hospitals, all patients who come to the ED after normal business hours are assigned to the ED’s on-call physician, though that is less commonly the policy.

To summarize: When an individual is covering their own practice’s patients, that person is not generally considered to be on the ED’s on-call roster.  As long as hospital policy allows it, a practice can choose any of its practitioners to respond to calls to the practice about their own patients.

For the ED roster that is designed with EMTALA compliance in mind, however, a physician must be listed (by name, not by group practice).  It is likely that this is the way your hospital has been managing things, since the requirement for a physician to be listed has not changed.  The confusion generated during the recent audio conference that you listened to probably lies in the ambiguity over the term “on-call roster.”

October 22, 2020

Posted on by hortyspringer

QUESTION:        We have a new crop of Medical Staff leaders taking office on January 1.  How do we get them up to speed with no live seminars this fall?

ANSWER:          Fear not! Horty Springer is bringing its live seminars to a virtual platform, so your new Medical Staff Officers, chairs, and committee members can get all the education they need to become effective physician leaders in the New Year!

These courses will provide the same engaging, practical, and entertaining content that you expect from Horty Springer right to your PC, laptop, or iPad, so please join us this fall!

 

October 15, 2020

Posted on by hortyspringer

QUESTION:        In the Tayefeh v. Kern Medical Center case summarized in this week’s Health Law Express, there was confusion about whether the physician was entitled to a Medical Staff hearing because of his failure to disclose certain unfavorable information and the resulting “termination” of his clinical privileges.  Is there any way that we can make it clear in our Medical Staff Bylaws or Credentials Policy that such an event does not give rise to a hearing?

 

ANSWER:          Yes.  While it is always important to consult requirements under state law, which may address situations when a hearing is required (we saw the California Business and Professions Code come into play in the Tayefeh case), your Medical Staff Bylaws or Credentials Policy (“Bylaws”) should clearly define the consequences for certain events and the circumstances that give rise to a hearing.  In Tayefeh, the physician failed to disclose an “accusation” filed against him by the Medical Board of California.  The Bylaws should spell out the results of failing to disclose information requested on the application and instruct that any misstatement in, or omission from, the application is grounds to stop processing the application. A decision not to process an application for these reasons does not entitle the applicant to a hearing or appeal.

With that in mind, it also makes sense to review your application forms to confirm that the application questions are seeking information that you need to make an informed decision about someone’s qualifications.  For example, the hospital’s application in the Tayefeh case not only sought information on past actions by licensing boards, it also asked for information on pending actions.  Confirm that the questions on the application form are consistent with provisions in the Bylaws with respect to the threshold eligibility criteria that someone must satisfy for eligibility for appointment.  If one of your threshold eligibility criterion requires an applicant to “have a current, unrestricted license to practice that has never been subject to any restrictions, conditions, or probationary terms and have never had a license to practice in any jurisdiction denied, revoked, restricted or suspended by a state licensing agency,” then there should be a corresponding question on the application seeking this information.

Finally, your Bylaws should place an obligation on members to notify the Medical Staff Office of any change in information provided as a part of the application and state that a failure to do so may result in administrative relinquishment of appointment and clinical privileges.  This permits the Medical Staff and Hospital to evaluate any changes in an individual’s qualifications, weigh those changes against eligibility criteria, and assess the appropriateness of any applicable consequences under the Bylaws.  Unless state law requires it, an administrative relinquishment of appointment and clinical privileges because of failure to continuously satisfy threshold eligibility criteria does not give rise to a Medical Staff hearing.

October 8, 2020

Posted on by hortyspringer

QUESTION:        Our Medical Staff Bylaws require all bylaws amendments to be accomplished at an officially called, in-person meeting.  As a result, we have been compiling revisions for months (years?) because of the logistics involved in getting this done.  The issue has now come to a head because we have revisions that really have to get into our Bylaws in preparation for an upcoming survey.  Do medical staffs really still vote on bylaws amendments in meetings?  No one shows up for meetings any more — even before the complications created by the current pandemic! Is this still a current practice?  Should it be?

 

ANSWER:           In our experience working with medical staffs across the country, the answer has pretty clearly become no.  While it was traditional for big things — like bylaws amendments and voting on medical staff officers — to occur in in-person medical staff meetings, that tradition has been changing significantly over the past decade.  The negative spin on the move away from in-person voting is that people have stopped showing up for meetings — there just isn’t enough time in the day for all of the patient care issues that have to be addressed to then make time for medical staff citizenship obligations.  However, what we hear most often is the positive side of this coin — which is that by moving away from in-person meetings to take action, which, no matter when they are held (early morning, lunchtime, or late afternoon/evening) will exclude some portion of the medical staff, it is a way to get the input of a much more board cross-section of the medical staff.  The reality is that folks have more time to read an email that includes the proposed amendment and a description of the rationale than they to do attend a meeting.

We have also worked with a number of medical staffs that have opted to “open forum” meetings to discuss proposed bylaws amendments (generally when there is a comprehensive revision process underway), but then conduct the actual vote through email or other electronic ballot — again, attempting to reach as many members of the medical staff as possible.

October 1, 2020

Posted on by hortyspringer

QUESTION:        We unintentionally sent an unencrypted email containing Protected Health Information (“PHI”) to the wrong person, who is a business associate.  Is sending an unencrypted email a HIPAA breach?

ANSWER:          No.  The HIPAA Rules that come into play here are the Privacy Rule and the Security Rule.  HIPAA defines “breach” to mean the acquisition, access, use or disclosure of PHI “in a manner not permitted under [the Privacy Rule]….”  So, a “breach” can occur only if the Privacy Rule is violated – Security Rules violations are not “breaches” – and merely sending an unencrypted email containing PHI, without more, does not violate the Privacy Rule (however, sending an unencrypted email could possibly violate the Security Rule, since it has standards that discuss encryption).

Alright, since a “breach” did not occur by sending an unencrypted email, did a HIPAA “breach” occur when the email was sent to the business associate?  The answer is “no” since the HIPAA definition of “breach” has an exception that states as follows:

“Breach excludes…any unintentional acquisition, access, or use of PHI by a workforce member…of a covered entity or a business associate, if such acquisition, access, or use was made in good faith and within the scope of authority and does not result in further use or disclosure in a manner not permitted under [the HIPAA Privacy Rule.]”

In this case, the business associate “acquired” the PHI by opening the e-mail, which was unintentional.  In other words, the business associate did not mean to acquire the PHI (as opposed to actively trying to gain access to information), and was acting within the scope of his/her employment, in good faith, and did not further disclose the PHI.  Thus, there was no HIPAA breach.

September 24, 2020

Posted on by hortyspringer

QUESTION:         May a physician be on-call for more than one hospital at the same time (take “simultaneous call”) or perform elective surgeries while on call?  If so, is that physician required to identify a specific back-up physician who will take calls at our hospital if the original physician is called to another hospital or is in the middle of an elective surgery when called by our hospital?

 

ANSWER:           CMS doesn’t specifically require that another physician be identified to take back-up call if the original on-call physician is performing elective surgery or is taking call at another hospital when the ED needs assistance.  Instead, CMS says that a “back-up plan” must be in place.  Per CMS, “some hospitals may employ the use of ‘jeopardy’ or back-up call schedules,” indicating that other hospitals may choose to not use back-up call schedules.  Here’s the full quote from the EMTALA Interpretive Guidelines (found in Appendix V of the Medicare State Operations Manual):

The [hospital’s] policies and procedures must also ensure that the hospital provides emergency services that meet the needs of an individual with an EMC [Emergency Medical Condition] if the hospital chooses to employ any of the on-call options permitted under the regulations, i.e., community call, simultaneous call, or elective procedures while on-call. In other words, there must be a back-up plan to these optional arrangements. For instance, some hospitals may employ the use of “jeopardy” or back-up call schedules to be used only under extreme circumstances. The hospital must be able to demonstrate that hospital staff is aware of and able to execute the back-up procedures.

https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_v_emerg.pdf

Of course, a hospital may decide that it’s On-Call Policy will not permit simultaneous call or elective surgeries while on call.  Or, a hospital’s policy may require on-call physicians to identify a specific individual to provide back-up coverage in such cases.  The key is to clearly identify the requirements in the hospital’s On-Call Policy.

September 17, 2020

Posted on by jwilbert

QUESTION:        Some big drug companies sent letters to our hospital saying that they would stop selling us 340B drugs unless we participate in the 340B “ESP” program and give them specific claims information.  Is this legal?

 

ANSWER:          There is some question as to whether drug companies can condition the sale of 340B to submitting this kind of information.  The letters we have seen cite concerns about duplicate discounts between the Medicaid and the 340B program. These requests also raise serious questions about whether the disclosure of claims information would comply with HIPAA unless the protected health information is de-identified – which is easier said than done – or the drug companies sign business associate agreements – which is unlikely. The American Hospital Association recently sent a letter to the Secretary of HHS in opposition to these requests. Some of the requests set a deadline of October 1 for compliance, but it is doubtful that the matter will be resolved by then.  Stay tuned for further developments.  For more information, contact Henry Casale at hcasale@hortyspringer.com or 412-687-7677.