Author: hortyspringer

October 26, 2017

Posted on by hortyspringer

QUESTION:        Can a hospital require visitors for a patient in isolation who has an infection resistant to antibiotics (e.g., C. diff) to use personal protective equipment while visiting the patient to limit the risk of spreading the infectious disease?

ANSWER:            The short answer is that there is no prohibition on such a requirement.  However, the requirement, and the reasons for the requirement, should be specified in hospital policies.

CMS requires “a hospital [to] have written policies and procedures regarding the visitation rights of patients, including those setting forth any clinically necessary or reasonable restriction or limitation that the hospital may need to place on such rights and the reasons for the clinical restriction or limitation.”  CMS’s guidance on this requirement specifically recognizes “infection control issues” as a circumstance in which a clinically necessary or reasonable restriction may be imposed.

The CMS rules also require hospitals to establish “an active program for the prevention, control, and investigation of infections and communicable diseases.”  According to CMS’s guidance, a hospital’s infection control program must address “[m]itigation of risks associated with patient infections present upon admission” and include “[a]ppropriate use of personal protective equipment including gowns, gloves, masks and eye protection devices.”

State hospital licensing regulations which address the issue are generally consistent with the CMS rules.  As an example, the Arizona Hospital Licensing Regulations instruct that hospitals are required to have “[p]olicies and procedures…[t]o prevent or minimize, identify, report, and investigate infections and communicable diseases that include:…iv. Using personal protective equipment such as gowns, masks, or face protection….”

The literature on the subject supports the opinion that a requirement for visitors to don personal protective equipment while visiting patients in isolation is “clinically necessary” or a “reasonable restriction.”  For example, a July 2015 article (“Precautions Guidelines for Hospital Visitors”) in the American Journal of Nursing cited recommendations from the Society for Healthcare Epidemiology of America.  According to the article:

For visitors’ protection, the authors recommend contact precautions (gowns and gloves) when enteric pathogens, such as Clostridium difficile or norovirus, or extensively drug-resistant pathogens, such as Klebsiella pneumoniae carbapenemase, are not widely prevalent in the community or when their prevalence is unknown.  Those visiting multiple patients should follow contact isolation precautions and use personal protective equipment.

In conclusion, there is no prohibition on requiring personal protective equipment for visitors of patients in isolation.  This would likely be considered a “clinically necessary” and/or “reasonable restriction” on visitation and part of a hospital’s “infection control program.”  The hospital’s policies and procedures should explicitly spell out this requirement, when it applies, and the reasons for it.

October 19, 2017

Posted on by hortyspringer

QUESTION:        The hospital across town is very lax with its on-call schedule. Even though this other hospital has numerous physicians in certain specialties, it keeps transferring ED patients to us because it doesn’t have anyone on call in that specialty who can treat the patient. Our physicians feel like they’re on call for the other hospital as well as our own. Do we have to accept these transfers?

ANSWER:            Yes. Under EMTALA, a receiving hospital has the right to refuse a request for a “lateral” transfer. A lateral transfer occurs where the same services are provided at both the sending hospital and the receiving hospital. Such a refusal does not violate EMTALA even though it may be in the patient’s best interest for the transfer to be accepted.

However, if the receiving hospital has “specialized capabilities,” and also has the capacity to stabilize the patient’s emergency medical condition, then the receiving hospital must accept the patient.

EMTALA itself lists burn units, shock trauma units and neonatal units as examples of “specialized capabilities.” However, courts and CMS have taken the position that an on-call physician also constitutes a “specialized capability.” Thus, if your hospital has an on-call physician available, and the hospital proposing the transfer doesn’t have an on-call physician available, your hospital must accept the transfer if it has the capacity to take care of the patient. This is true even if the sending hospital has specialists on its staff who could treat the patient if they were on call (but who are not actually on call).

This requirement has put hospitals across the country, and their on-call physicians, in a difficult position. Essentially, this requirement can make on-call physicians at Hospital B (the receiving hospital) responsible not only for Hospital B’s ED patients, but also potentially for many of Hospital A’s (the sending Hospital) ED patients. That could be because Hospital A doesn’t have the needed specialist on its medical staff or because Hospital A has a less rigorous call schedule than Hospital B.

To learn more about this issue, please join Phil Zarone and Ian Donaldson on November 7, 2017 for an audio conference on “On-Call and EMTALA Policies.” For more information, click here.

October 12, 2017

Posted on by hortyspringer

QUESTION:        Our hospital operates an emergency room and has an inpatient behavioral health unit.  Our emergency room has evaluated a patient with mental illness on numerous occasions, typically on “emergency certificates” under our state law.  In the past, this particular patient has been violent and assaultive toward staff in the emergency room.  Under the Emergency Medical Treatment and Active Labor Act (“EMTALA”), are we permitted to refuse to admit this patient to our behavioral health unit the next time he comes to the emergency room with a psychiatric emergency?

ANSWER:            That’s a very good question, and for any individual hospital, the best answer probably comes from its CMS Regional Office.  Each Regional Office has EMTALA “jurisdiction” over its region.  It is the Regional Office that determines whether there has been an EMTALA violation or not if a complaint is received.

Under EMTALA, the hospital is required to perform a medical screening examination on the patient when he is brought to the emergency room to determine if the patient has an emergency medical condition.  The definition of “emergency medical condition” under EMTALA includes a psychiatric emergency medical condition.

If the patient has a psychiatric emergency medical condition, the EMTALA duty on the hospital is to stabilize that emergency medical condition if the hospital has the capacity and the capability to do so.  Because this hospital has a behavioral health unit, it has the services and resources to stabilize a psychiatric emergency medical condition.  (That’s assuming the behavioral health unit has an available bed.)

Many hospitals do not have forensic units, nor are they staffed to address violent psychiatric patients.  The EMTALA regulations state that a hospital is to provide stabilizing treatment within the capabilities of the staff and facilities available at the hospital.  Thus, there is an EMTALA argument to make that treating a violent psychiatric patient does not come within the capabilities of a hospital’s behavioral health unit.

However, in our discussions with one CMS Regional Office, a representative informed us that the Regional Office expects all behavioral health units to be able to handle a certain level of violence in a psychiatric patient.  If a complaint was ever brought about the rejection of a patient with a psychiatric emergency medical condition, the Regional Office would have its own psychiatrist review and determine whether the violence level of the patient exceeded the behavioral health unit’s capabilities and resources.  If the Regional Office psychiatrist felt that the behavioral health unit could have managed the patient, there would be an EMTALA violation.

Notwithstanding the EMTALA implications of the situation, the most important consideration is the safety of the staff of the hospital and the patient.  A more proactive approach might be useful in which representatives from the hospital (including its security staff) sit down to discuss a method to handle violent patients in general.  The development of this method may be assisted by involving the local police, especially if the circumstances involve a patient or patients who have been assaultive in the past and/or have threatened to assault hospital staff in the future.

This is a very difficult issue, but a well-defined plan or policy that includes input from all those potentially involved would help in understanding the issue, achieving buy-in, complying with the law, and, most importantly, protecting staff and patients.

For more information on this topic, join Susan Lapenta and Phil Zarone on November 7, 2017 for the On-Call and EMTALA Policies audio conference (part of the Horty, Springer & Mattern Grand Rounds audio conference series).

October 5, 2017

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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.

September 28, 2017

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QUESTION:        It has been several years since we have negotiated a new exclusive agreement.  I seem to recall that the IRS had rules that required a pretty specific term and termination provision.  I also understand there has been a change in those rules that have eliminated those requirements but now require the hospital to monitor how much the exclusive provider can charge our patients for their professional services.  Is this accurate?

 

ANSWER:             Yes, tax-exempt hospitals should be aware that Revenue Procedure (Rev. Proc.) 2017-13 has superseded and replaced the old IRS rules that specified a specific term and termination provision.  Rev. Proc. 2017-13 also added a new rule that requires the hospital to exercise a certain amount of control over the professional fees that are charged by the exclusive provider.  Even if Rev. Proc. 2017-13 does not apply to your hospital, you are well advised to follow it.

First, what old rules no longer apply?  IRS Revenue Procedure (Rev. Proc.) 97-13 used to require tax-exempt hospitals to satisfy a safe harbor in the Rev. Proc. that was based on the term of the exclusive agreement and the manner in which the exclusive agreement could be terminated.

The safe harbor that applied to most exclusive agreements limited the term of the agreement to three years and required that the exclusive agreement must be able to be terminated without cause or penalty after two years.  The IRS first modified Rev. Proc. 97-13 in 2014 and then in 2016, and more recently in 2017, has superseded and replaced Rev. Proc. 97-13 with Rev. Proc. 2017-13.

Rev. Proc. 2017-13 applies to exclusive agreements that are entered into after January 17, 2017.  Rev. Proc. 2017-13 has completely superseded Rev. Proc. 97-13 and no longer requires the term and termination provisions that had been set forth in Rev. Proc. 97-13.  However, among the new requirements imposed on tax-exempt hospitals by Rev. Proc. 2017-13 is that the hospital must either approve the rates charged by the exclusive provider, or at least require that the exclusive provider “charge rates that are reasonable and customary as specifically determined by or negotiated with, an independent third party (such as a medical insurance company).”  In order to further the hospital’s charitable mission, the exclusive provider should also agree to provide the professional services that are subject to the exclusive agreement to all hospital patients regardless of insurance status or ability to pay and agree that when billing for their professional services, the exclusive provider will follow the hospital’s charity care policy.

In addition, it is vital to a hospital’s ability to execute an agreement with any third-party reimbursement program, that an exclusive agreement provide the hospital with the ability to require the exclusive provider to be bound to any third-party reimbursement program that the hospital directs.  Given the current market conditions in which most hospitals must operate, being able to provide the hospital’s services to the patients of any third-party reimbursement program is an important pro-competitive element relating to the cost, quality and accessibility of services that justify granting an exclusive franchise to one group of individuals who provide a vital, hospital-based service.  We recommend that hospitals include this term in all exclusive agreements, regardless of whether Rev. Proc. 2017-13 applies to the hospital.

That is not to say that there are no legal restrictions on the term of a hospital-physician exclusive agreement.  All exclusive agreements have both pro-competitive and anti-competitive aspects and will be lawful so long as the pro-competitive aspects outweigh the anti-competitive ones.  The term is an important factor in this pro-competitive analysis.

The FTC has long taken the position that three years is a reasonable term for an exclusive agreement.  We continue to recommend that hospitals follow this advice and that for antitrust and for a number of practical reasons, the term of an exclusive agreement should be limited to three years, and should never exceed five years.

While no longer required by the IRS, the ability of either party to terminate the exclusive agreement at any time without cause is a very good idea.  A termination without cause provision allows either party to terminate the exclusive agreement when the agreement is no longer in that party’s best interest.  A no-cause termination clause also allows both parties the time needed for a smooth transition from one exclusive provider to the next.

What about a “for-cause” termination provision?  In our experience, it is extremely difficult to define cause to terminate an exclusive agreement.  This is true even if the exclusive agreement includes specific performance standards (which are often difficult to negotiate).  If a party is in material breach of an exclusive agreement, you do not want that party to continue to be present providing an important hospital service.  Therefore, the cure period in a for-cause termination provision is usually very short (30-45 days).  However, such a short period of time presents several practical problems.  First, you don’t know if the party in material breach will cure that breach until after the cure period has ended.  More importantly, a short cure period also does not allow a sufficient period of time to locate a new exclusive provider let alone provide that new exclusive provider with the time needed to obtain billing numbers.

Of greater concern is the practical reality that terminating an exclusive agreement “for cause” seldom allows for a smooth transition from one exclusive provider to the next.  A for-cause termination can also result in a legal challenge if a party disagrees that cause exists to terminate the exclusive agreement.  Whether a party had legal cause to terminate the exclusive agreement is an issue of fact that will require years of litigation and a jury to resolve.  Years of litigation, an uncertain result, and a messy transition from one exclusive provider to the next is not what a hospital bargains for when it enters into an exclusive agreement.

For more information on the latest legal issues affecting hospital-physician contracts, join Dan and Henry in Austin, Texas on March 1-3 at our Physician-Hospital Contracts Clinic.

September 21, 2017

Posted on by hortyspringer

QUESTION:        We’re trying to create a standardized job description for surgical assistants.  Are there any uniform standards or best practices we should follow?

ANSWER:            The most important thing to keep in mind is that surgical assistants may differ dramatically in terms of their education and skill set.  Even the term “surgical assistant” can cover a wide range of different practitioners.

In almost all cases, you will need to grant clinical privileges to surgical assistants.  The Centers for Medicare & Medicaid Services (“CMS”) mandates that hospitals delineate privileges for all practitioners who perform surgical tasks.  This includes practitioners who perform surgical tasks under the supervision of an M.D. or D.O.  (If you are Joint Commission-accredited, you will also need to conduct appropriate professional practice evaluations to confirm competence.)  You will also need to check your state law.  In most states, the surgical assistant profession is not directly regulated.  Others, like Texas, have instituted a licensure process for surgical assistants.

When you are dealing with new applicants for the surgical assistant position, it’s advisable to do some research on their education and training.  Some surgical assistant training programs can be completed within four months.  Others last for two years.  In some programs, almost all of the coursework is taught online and then supplemented by a brief period of hands-on training.  Other programs subject students to an extensive clinical training phase that lasts nearly a year.

If your hospital’s policies and culture allow surgical assistants to play a significant role and to perform significant surgical tasks, it’s advisable to set a high bar in your credentialing and privileging process.  Look for experienced candidates from high-quality programs with extensive, hands-on clinical training.  If the person is certified, inquire about the general requirements for certification.

If you have the resources, consider appointing a task force of interested individuals.  The task force can do research on different educational programs, different kinds of program accreditation, and different types of surgical assistant certification.  The information can then be assembled into a chart for easy comparison.  We also recommend that you seek input from surgeons at neighboring institutions to see whether they have any preferences, recommendations, or cautionary tales to share.  The task force would eventually make a report to your Credentials Committee, Allied Health Professionals Committee, or Committee on Interdisciplinary Practice (as appropriate).

Ultimately, it is important to err on the side of caution.  Although surgical assistants will be supervised by the surgeon, it is important to build in additional safeguards to catch problem applicants before they see a patient.  Strong credentialing and privileging standards will help your surgeons build a team of assistants that they can rely on, and will further strengthen the quality of care at your institution.

September 7, 2017

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QUESTION:        I heard that CMS is planning to cancel its upcoming episode payment models.  Is this true?

ANSWER:            Yes.  In mid-August, CMS issued a proposed rule that would cancel its upcoming episode payment models (“EPMs”) and cardiac rehabilitation incentive payment model.  The rule also proposed revisions to the existing Comprehensive Care for Joint Replacement model (“CJR program”).  This proposal marks a significant change of course for the agency’s regulatory agenda, given that CMS had previously expressed an intent only to delay these models, not cancel them outright.

The upcoming EPMs would have affected Medicare beneficiaries undergoing services related to acute myocardial infarctions, coronary artery bypass grafts, and surgical hip/femur fracture treatment.  The rule has not been finalized, so the ultimate fate of these payment models remains uncertain.  CMS will continue to accept comments (as part of the standard notice and comment rulemaking process) on this proposal until October 16, 2017.

If the proposed rule is finalized, it will also give hospitals participating in the CJR program a one-time opportunity to exit the program.  This is likely the beginning of a future trend away from mandatory payment models (such as the CJR program) in favor of voluntary value-based payment programs.

We continue to recommend that you build flexibility into your planning processes to account for this uncertainty in CMS’s rulemaking activities.

The proposed rule is available here.

August 31, 2017

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QUESTION:        Is there any way we can help hospitals and their employees who have been affected by Hurricane Harvey?

ANSWER:           Thanks for caring.  The Texas Hospital Association has established the THA Hospital Employee Assistance Fund to assist hospital employees who experienced significant property loss or damage during Hurricane Harvey.

August 24, 2017

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QUESTION:        Our hospital-affiliated group has identified a new candidate that they are very interested in employing.  The candidate disclosed that she had a problem in the past that has been resolved.  It turns out that, three years ago, the physician was arrested and charged with second degree cruelty to children, a felony.  The charges were filed after the physician brought her infant daughter to the ED with a fractured femur.  According to the affidavit filed in support of the arrest, the injury, along with others suffered by the child, raised a concern about child abuse.  The charges were subsequently dismissed.

Our group knows about the charges, but says all of her references are outstanding.  They are willing to give her a chance.  What do we do?

ANSWER:            Whenever there is an issue or a concern with an applicant, we recommend you pause and remember to keep “the burden on the applicant.” The applicant has the burden to address and resolve any questions that are raised during the initial appointment process.

When an applicant has had a recent criminal arrest, especially for a felony, you will want to explore, with the applicant, issues surrounding the charges, including the resolution of the charges.  Make sure you check state law first to see if there is a prohibition against asking questions about criminal matters when the charges have been dismissed.  Consider asking the applicant about the charges, the ultimate disposition of the charges, and the conditions pursuant to which the charges were dismissed.

Also consider whether the charges might have triggered an obligation on the part of the physician to notify the state medical board or the hospital where the physician was practicing and ask the physician whether she provided the required notice.  If the physician did not provide notice, especially if required, this should be explored as well.  You might also inquire about steps the physician has taken to address underlying issues that contributed to the criminal charges.   Consider requiring the physician to provide the hospital with correspondence to and from the prosecuting attorney regarding the charges and the dismissal of the charges and any conditions that were imposed.

Minor criminal offenses, especially when the matter is old and there has been no repeat offense, may not derail an application or a favorable employment decision completely.  However, serious charges, especially when the charges are recent, go to the issue of a physician’s reputation, character, ethics and perhaps integrity and require careful review and consideration.

 

August 17, 2017

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QUESTION:        The Chief of Staff recently implemented a precautionary suspension after a Medical Staff member engaged in some seriously unprofessional behavior that was thought to compromise patient safety.  The MEC met to review the matter and lifted the precautionary suspension after four days.  A formal investigation was commenced and that process is now complete and the MEC is considering suspending the practitioner for 30 days.  For purposes of reporting to the National Practitioner Data Bank (NPDB), will that suspension be added to the four-day suspension he already served — meaning that it will constitute a 34-day suspension and will, in turn, become reportable to the NPDB as a suspension lasting more than 30 days?

ANSWER:            Even though the precautionary suspension and the “regular” suspension are related to the same factual matter, they are separate professional review actions and, in turn, they do not “add up” for the sake of reporting.  Therefore, the four-day precautionary suspension was not reportable to the NPDB.  The same will be true of a 30-day suspension, if that action is finalized by the Board.  Be sure to check the applicable requirements of state law, however, as some states require hospitals to report all suspensions of clinical privileges, no matter how long they last.