June 4, 2015

QUESTION:        Can credentials and peer review information about a practitioner be shared with a sister hospital if the sister hospital has the same Board but each has its own separate Medical Staff?  Should they?

ANSWER:         Hospitals that are affiliated under the same Board, in a system, can exchange information, although we recommend several steps to maximize legal protection. We generally recommend including a provision in each hospital’s medical staff bylaws or credentials policy, as well as a statement on the application form, that the applicant understands that information will be shared among entities in the system and that the sharing of this information is not intended to be a waiver of the state peer review protection statute. It is also a good idea to have a formal information sharing agreement among the hospitals which clearly defines what information will be shared, when it will be shared, and to whom it will be forwarded.

As for whether the hospitals should share information, the answer is yes. Two hospitals under one Board would be considered one corporate entity. Each individual hospital (or clinic, health plan, ambulatory surgery center and any other related facility) is part of that one entity. Important to the medical staff leaders responsible for helping to maintain high standards of care through careful and thorough credentialing of physicians, is the fact that because it is one entity, credentialers may be “deemed” to be making recommendations as to whether a specific practitioner is qualified and competent based on the collective knowledge of the entity as a whole, rather than the knowledge contained within an individual hospital. The standard in the law – when it comes to doling out liability – is that the credentialers “knew or should have known” the relevant information that came from the sister facility.

May 28, 2015

QUESTION:        We have a very small neurosurgery department at our hospital, where the active members of the medical staff are obligated to provide ED call. Assuming that we only have two neurosurgeons that are able to cover ED call, does this mean they must each take 180 days of call each year? Our physician leaders are telling us that this is a tremendous burden, but we do not want to violate EMTALA.

ANSWER:        A tough question, made even tougher by the fact that CMS has provided very little guidance on the reasonableness of hospital call schedules. In fact, the best rule of thumb comes from historical guidance from CMS that CMS now specifically denounces!

To begin, it is important to keep in mind that CMS does not require 24/7/365 coverage. Instead, it uses a rather nebulous “all relevant” factors test to evaluate the reasonableness of a hospital’s coverage arrangements. Frankly, this is not a very helpful rule, so many organizations that we work with take a “rule of three” approach, as it relates to provider on-call responsibilities. This approach is based on prior, informal guidance from CMS that said if there were three physicians in a particular clinical specialty on a medical staff, the hospital had the obligation to provide emergency services on a 24/7/365 basis for that specialty. This has been extrapolated to mean that, in a single physician specialty, call would need to be provided only one-third of the time (i.e., 10 days/month). This would mean the hospital above would have neurosurgery coverage for 20 days out of the month.

While CMS has explicitly denied the rule of three ever existed, we think this is a relatively safe position to take in terms of EMTALA compliance. Of course, we have seen other facilities adopt a “rule of four” or even a “rule of five” where they have found the obligation created under the “rule of three” to be too burdensome or if there are other “relevant factors” that would justify another approach (e.g., the number of physicians available to take call, other demands on these physicians, frequency of emergency cases in that specialty, etc.).

May 21, 2015

QUESTION:        We are currently in the process of revising our Medical Staff Bylaws and have been trying to pin down the requirements for the history and physical (“H&P”) provisions in the Bylaws. As a starting point, could you let us know what details are required by federal law and regulations and accreditation standards?

ANSWER:        The Medicare Conditions of Participation for hospitals (“CoPs”) have several requirements for what must be included in the Medical Staff Bylaws when it comes to H&Ps. The CoPs require that the Bylaws include a requirement that a physician, oromaxillofacial surgeon, or “other qualified licensed individual in accordance with State law and hospital policy” complete an H&P no more than 30 days before or 24 hours after admission or registration, but at all times prior to surgery or a procedure requiring anesthesia services. When the H&P is conducted within 30 days before admission or registration, an update (which notes any changes in the patient’s condition) has to be completed and documented by a licensed practitioner, who holds privileges at the hospital to perform an H&P, within 24 hours after admission or registration but always before surgery or a procedure requiring anesthesia.

The CoPs do not address content-related requirements of H&Ps, other than noting in the Interpretive Guidelines that “[t]he purpose of a medical history and physical examination…is to determine whether there is anything in the patient’s overall condition that would affect the planned course of the patient’s treatment, such as a medication allergy, or a new or existing co?morbid condition that requires additional interventions to reduce risk to the patient.”

The Joint Commission Accreditation Standards reiterate the timing requirements for H&Ps and are, similar to the CoPs, not overly prescriptive when it comes to content-related details. In a recent FAQ posted on its website on March 5, 2015, the Joint Commission noted, generally, that “[o]rganizations have the flexibility of determining the content of the H&P based on the population served and the services provided.” Some additional guidance is contained in the glossary of the hospital Standards, which provide a definition for an H&P. That definition indicates that the history portion “may include information about previous illness, previous medical or surgical interventions and response to treatment, family health history, and social, cultural, economic, and lifestyle issues that may affect an individual’s health and well-being” (emphasis added). The physical portion “involves the physical examination of the individual’s body by the following means: inspection, palpation, percussion, and auscultation….”

Under the CoPs and Joint Commission Accreditation Standards, there is no requirement that the content-related details of H&Ps be included in the Bylaws. Thus, these content-related details may be included in other medical staff documents, such as the Medical Staff Rules and Regulations (however, we recommend including all the details for H&Ps in the Bylaws for ease of reference).

Occasionally, state law and regulations will contain H&P requirements that are different, and at times more restrictive, than the CoPs and the Joint Commission’s Standards. The same applies for commercial insurer billing requirements. Commercial insurers will often dictate what needs to be included in the H&P (e.g., age, height, vital signs, past medical and behavioral history, family history, physical examination, medical impression, etc.) for reimbursement purposes. Accordingly, state law and regulations, as well as any commercial insurer (with which your hospital contracts) requirements, must be consulted when deciding on what will be included in the H&P sections of your Medical Staff documents.

May 14, 2015

QUESTION:        Would our state statutory peer review privilege be jeopardized if non-physician support personnel or other representatives of the management team or board attended peer review committee meetings?

ANSWER:        No. It is our experience that the most effective peer review processes result when there is a collaborative approach among the physicians, and other practitioners, non-practitioner support personnel, and hospital representatives. (The latter commonly serve as non-voting members but most committees strive for consensus in today’s world.) (Readers should check with counsel about any specific case law in their states, but – based on our research – the fear of a “waiver” ruling by a court is far greater than the incidence of actual court opinions holding that providing peer review information to someone in a committee meeting, who is not a voting committee member, waives the privilege.) It is becoming increasingly common for a board member to attend credentials committee and MEC meetings as well. State peer review privilege laws do not generally limit the protection to meetings at which only physicians are present (and documents generated at or for such meetings). In fact, the presence of management team or board members may bolster the legal protection available by making clear that the committee’s discussions advance the general interest in quality patient care, and not the interests of any individual physicians. A hospital’s overall responsibility for the peer review process is also outlined in the Medicare Conditions of Participation and most hospital licensing regulations. (For hospitals choosing to be accredited by The Joint Commission, the CEO is to be present at MEC meetings.) The governing board is legally responsible for everything that occurs in the hospital, including credentialing and peer review, with the medical staff committees, departments and leaders being accountable to the governing board for oversight of the quality of care provided to patients. Nonetheless, all individuals present at such meetings should sign confidentiality agreements, at least annually.

There may actually be risks to the physicians and the hospital if hospital personnel are excluded. First, such a practice could create the misperception that the medical staff and hospital are separate legal entities. This could make physicians and the hospital more vulnerable to certain types of lawsuits (e.g., antitrust and other conspiracy based claims). And, the presence of the CEO or designee or a board member at meetings of peer review committees strengthens the immunity provided by the federal Health Care Quality Improvement Act because it makes it clear that the committee is a “professional review body” that is “assisting the governing body in a professional review activity.” 42 C.F.R. §11151(11).

May 7, 2015

QUESTION:         We recently rejected an application for initial appointment because the applicant misrepresented information on his application – he failed to disclose that he had been investigated at another hospital. We heard that there is a new National Practitioner Data Bank Guidebook and that it is more expansive in terms of what has to be reported. Do we have to report our decision to the National Practitioner Data Bank?

ANSWER:         You are correct. There is a new NPDB Guidebook that was published on April 6, 2015. You are also correct that the new NPDB Guidebook is more expansive in some areas (especially with respect to when an investigation starts). And, your question is a good one. In fact, there is a similar question in the new NPDB Guidebook. The answer in the new NPDB Guidebook to whether a falsification on an application is reportable is “it depends.” We can be more definitive than that. In our opinion, if you have the right bylaws language and follow the right process, you do not have to report a decision to reject an application because of a misrepresentation or omission.

The new NPDB Guidebook took the position that a hospital would have to report a clinical privilege decision based on the falsification of an application if the hospital determined that the falsification “could adversely affect the health or welfare of a patient.” We recommend that your medical staff bylaws or credentials policy (“bylaws”) clearly state that an application that contains a misstatement or omission is rejected and not processed. Thus, there should be no adverse professional review action, there should be no findings or conclusions that the physician’s professional conduct “adversely affects or could adversely affect the health or welfare of a patient,” and there should be no report to the National Practitioner Data Bank.

Importantly, a decision to reject and not process an application is an administrative decision not an adverse professional review action. The new NPDB Guidebook makes it very clear that “Administrative actions that do not involve a professional review action should not be reported to the NPDB.”

Your bylaws should also clearly state that a rejection of an application does not “entitle the applicant or member to a hearing or appeal.” To reinforce this point, the section of the bylaws that deals with hearings should also state: “None of the following actions constitute grounds for a hearing. These actions take effect without hearing or appeal…a determination that an application will not be processed due to a misstatement or omission.”

April 30, 2015

Dealing With Dishonest Re-Applicants

QUESTION:        Late last year, we stopped processing the Medical Staff application of a physician who omitted an out-of-the-country residency training program that was begun but not completed from his application form. We considered the applicant’s explanation for the omission and determined that it was not credible. So, we chose not to process the application, pursuant to our Bylaws language that says that applications which include material misrepresentations or omissions may not be processed. The applicant was notified.

Last week, this same physician submitted a new application, this time listing the previously-omitted residency on the form. Do we have to process the application?

ANSWER:        Hospital and medical staff leaders are placed in a difficult position when an applicant who has previously lied to them seeks reconsideration. Luckily, there are a couple of ways to deal with a re-applicant who has a history of material misrepresentations or omissions.

One option is to adopt language in your Medical Staff Bylaws or Credentials Policy stating that an individual who has previously had an application for appointment or privileges deemed ineligible for processing due to a material misrepresentation or omission is ineligible to apply or, alternatively, is ineligible to apply for some specified period of time (such as three or five years). With such language in hand, you need not engage in verifying or processing any re-applications by an individual who has previously filed an application with a material misstatement or omission.

In the absence of such Bylaws or policy language, you still need not process the application as if nothing happened. Rather, we recommend that you deem the application incomplete due to the unresolved concern involving the veracity of the applicant. You can then rely on your Bylaws (or Credentials Policy) language stating that incomplete applications will not be processed and that applicants have the burden of completing their applications.

In the case of an applicant who has made a misstatement or material omission on a previous application, you should notify the individual that the application remains incomplete due to the unresolved concerns over the individual’s veracity – and then inform the individual of the deadline for submitting sufficient information to resolve that concern (for example, information showing that the individual has taken steps to address his or her lack of veracity).

It can be difficult for an individual who has lied on a previous occasion to resolve the concern that they will lie again in the future. After all, how would the hospital and medical staff leadership know whether the individual is being honest, except by being constantly vigilant in verifying every little fact that the applicant asserts? The re?applicant may choose to submit evidence indicating that the previous misrepresentations or omissions were related to an addiction problem that caused him or her to lie – and that he or she is now in treatment. Perhaps the re-applicant could show that he or she attended a professional ethics class or started filling out applications personally instead of relying on his or her office staff to do so. If the re-applicant submits any such information – and if the leadership truly believes that the information resolves the concern that the individual will lie again – then it may choose to process the application. If not, the applicant can be informed that the information is insufficient and the application will remain incomplete until such time as additional information deemed sufficient by the leadership is received.

Of course, most Medical Staff Bylaws and Credentials Policies include language stating that if an incomplete application is not completed within 30 days of notice being provided to the applicant, then the application will be deemed withdrawn. So, if the re-applicant is not able to resolve the concerns with his or her veracity during that time period, the application can be deemed withdrawn, the re-applicant can be notified, and all processing can stop.

Want to learn more about addressing applicants – and re-applicants – with red flags in their applications? Join us this fall for The Credentialing Clinic, October 15-17, in Las Vegas. More information.

April 23, 2015

QUESTION:         The law in our state was recently changed and advance practice registered nurses (APRNs) are now allowed to practice independently. How should we handle this change in the law at our hospital? Can we continue to require collaboration agreements? Or should we eliminate that requirement and allow the APRNs to practice on their own?

ANSWER:        There is not a “right” answer to the question about how APRNs should practice in any hospital. There is a trend in licensing statutes around the country to allow APRNs to practice independently. An independent practice for APRNs makes a great deal of sense on an outpatient basis and may work in a hospital setting if you are in a rural setting where the option to have a collaborative relationship with a physician is limited.

However, even with a change in the law, your hospital is not required to allow APRNs to practice independently in your facility. Your hospital may want to put together a task force to consider whether there should be a change in practice for APRNs. In addition to other medical staff and hospital leaders, the task force could include APRNs and physicians who have a history of collaborating with them. Be careful not to load the task force with physicians who have an economic reason to limit the practice of APRNs.

The task force could gather information and then consider whether to recommend that APRNs continue to practice in a collaborative arrangement, whether all APRNs are permitted to practice independently or whether to recommend that the ability of APRNs to practice independently is made by practice specialty (e.g, nurse midwives, CRNAs, APRNs in the NICU).

The task force could also consider whether to recommend requirements for backup and coverage, especially for situations when a patient has a complication that requires expertise outside the scope of practice of the APRN. The task force might also be charged with reviewing how the care provided by APRNs will be evaluated through the peer review process.

It makes sense to continue to evaluate how care is provided to patients in your hospital and to look for ways to improve that care, including the way care is delivered. APRNs and Physician Assistants play a vital role in the delivery of care to patients in most hospitals. You should continue to look for ways to integrate these practitioners into your health care teams in a way that is safe and productive.

April 16, 2015

QUESTION:        Our hospital does not have a bariatric surgical program. In fact, we are concerned that neither our equipment nor our staff are up for handling obese patients. Can the hospital set a patient weight limit for an area of care, like the OR or the ICU?

ANSWER:        It’s an interesting question.

Under certain states’ statutes, employment law protects the obese from being discriminated against.  It appears that this idea is gaining steam to potentially create a new protected area under the federal ADA, again in terms of employment.  But, as of now, there does not appear to be any clear law that makes obesity a protected class in terms of receiving health care services.  Nonetheless, for good risk management purposes, any hospital’s rules as to care for obese patients should be based in reasonable principles and concerns.

The risk management issue arises when it appears that a hospital has set a weight number arbitrarily.  Any hospital rule should be based upon sound information and supporting data as to why the rule is needed, be that for the protection of the patient and/or the hospital and its staff.  Otherwise, this practice is more likely to expose the hospital to complaints and ethical questions of discrimination.

The clearest situation is where the hospital’s equipment is incapable of supporting the patient’s weight.  But where the equipment can accommodate the weight, there should be good reasons for the hospital’s position, be that injury to staff, clinical difficulties for treating the patient (outside of equipment weight-support/ability, etc.).  These would be specifics to the nature of the patient and/or the nature of the hospital and its resources.

On the ethical front, a statement from the American College of Obstetricians and Gynecologists is helpful as a guiding principle: “It is unethical for physicians to refuse to accept a patient or decline to continue care that is within their scope of practice solely because the patient is obese. However, if physicians lack the resources necessary for the safe and effective care of the obese patient, consultation or referral or both are appropriate.”

Obesity has been increasingly held to be a protected area in employment law, and employment termination due to weight discrimination has been successfully challenged a few times by the Equal Employment Opportunities Commission (EEOC).   In 2014, the AMA classified obesity as a medical disease for the first time.  All of this is moving in the direction of obesity to be classified as a disability in terms of employment.  Only time will tell whether this becomes a stepping stone for further expansion into other areas.

April 9, 2015

QUESTION:        We have been provided with a range of fair market rental values from a local real estate appraiser. Is this sufficient to benchmark the fair market value of the rent that we are charging?

ANSWER:        A range of fair market value from an experienced appraiser is an excellent start. However, in order to establish that the rent that you are charging constitutes a commercially reasonable, fair market value rent, you have to consider the totality of the circumstances that resulted in that range.

In U.S. ex rel. Goodstein v. McLaren Regional Medical Center, 202 F.Supp.2d 671 (E.D. Mich. S. Div. 2002) (the “McLaren Case”), a qui tam relator alleged that the rent being paid by a hospital to several orthopedic surgeons who owned a medical office building (and who were in a position to refer Medicare and Medicaid patients to that hospital and its orthopedic and physical therapy services) exceeded fair market value.

In the McLaren Case, the physicians were the landlord and the hospital was the tenant, so the issue was whether the rent paid by McLaren exceeded fair market value. However, the same legal principles apply, where a hospital is the landlord and a physician is the tenant, with the issue being whether the rent that the hospital will charge the physician is less than fair market value. In either event, the legal issue remains the same – whether the parties can prove that the rental rate set forth in the lease constitutes the fair market value of the space being leased.

The Court in the McLaren Case then ruled that based on the totality of the circumstances that the respective experts used to determine the rental rates set forth in their respective appraisals, the rental rate that McLaren agreed to pay the physician landlords was consistent with fair market value.

In reaching its conclusion, the Court carefully considered the facts that the Government’s experts used to determine the rent that the Government alleged should have been paid, and compared those facts to the facts that McLaren’s experts relied upon when they opined that the rental rate that was actually paid was at fair market value.

The key to the Court’s analysis was the comparability studies performed by each appraiser. This was so much so that the Court specifically stated that it did not consider the analysis performed by one of the Government’s experts because during his testimony this appraiser did not identify the comparables he used in his appraisals. Thus, the Court had no way of evaluating whether the appraiser used appropriate comparables in his appraisal.

The facts that the Court in the McLaren Case considered in its comparability analysis included the manner in which the rent in each building was determined (i.e., triple net versus a gross rental rate). The Court found that while comparing a triple net rental rate to a gross rental rate required the appraiser to adjust the respective rental rates to take into account the different rental formulas used, the Court also found that otherwise comparable buildings should not have been excluded from a comparability analysis merely because the manner used to determine the rental rate in that building was different than the rental charged in the building at issue.

However, the most important factor in the Court’s analysis was whether the buildings used in each expert’s comparability studies were of similar quality and location to the building at issue. The Court disagreed with the buildings that the Government used to allege a lower rate should have been charged in the building under consideration because of the Government experts’ use of comparables buildings that included: (i) a building without an elevator to one that contained one; (ii) an ADA-compliant building to one that was not; (iii) an older, “run down” building of inferior construction to a newer building; (iv) a building located in a flood plain to one that was not; (v) a building where the building and the parking lot had water problems to one that did not; (vi) a financially viable building to one that was in foreclosure or purchased at a fire sale; (vii) a building with numerous occupants to one where there was no commercial space for lease because it was entirely owner-occupied; and (viii) an older building with low ceilings and small windows that have not been remodeled since their construction 20 years earlier and was not well maintained to a modern, well-maintained building.

So, it is important to have a clear understanding as to how the range of fair market value was determined and to make sure that the comparable properties that were used as the basis for that range are truly comparable in physical structure and terms of the lease (i.e., Triple Net versus all inclusive).

April 2, 2015

QUESTION:    May physicians text or e-mail patient information to one another if such texts or e-mails are directly related to patient care? If so, does HIPAA require that such transmissions be encrypted?

ANSWER:       Any discussion of sending Protected Health Information (“PHI”) via text or e-mail should distinguish between: (1) the HIPAA Privacy Rule and (2) the HIPAA Security Rule:

(1)       The Privacy Rule is concerned with WHY information is being used or disclosed. Is there a permissible purpose? There is no violation of the Privacy Rule if a text or e-mail is for a treatment purpose.

(2)        The Security Rule is concerned with HOW information is transmitted and stored. Thus, while it may be appropriate for one physician to disclose PHI to another physician for treatment purposes, the Security Rule could be violated if the method used to transmit that information is improper.

The Security Rule has three categories of requirements:

(i)         Standards.

(ii)        Required Implementation Specifications.

(iii)       Addressable Implementation Specifications.

Covered entities must comply with all “Standards” and “Required Implementation Specifications.” As the name implies, “Addressable Implementation Specifications” do not always have to be implemented. Instead, each covered entity must evaluate whether an Addressable Implementation Specification is a “reasonable and appropriate safeguard in its environment, when analyzed with reference to the likely contribution to protecting” PHI. If so, the Addressable Implementation Specification must be implemented. If not, the covered entity must consider whether an alternative measure to protect security is feasible and must document its conclusions.

Encryption is an Addressable Implementation Specification. Thus, covered entities are expected to encrypt texts and e-mails if doing so is a “reasonable and appropriate safeguard in its environment.” In evaluating this question, covered entities should consider whether encryption would interfere with patient care (e.g., undue delays in transmission, retention of encrypted transmissions, etc.).