QUESTION: Why isn’t there a Question of the Week this week?
ANSWER: There is. We were just too busy to come up with anything more than this.
Question Of The Week
September 27, 2018
QUESTION: Is the peer review privilege the same thing as peer review immunity?
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ANSWER: No, there is a difference. The peer review privilege protects documents from disclosure in certain kinds of court cases. Peer review immunity protects participants in the peer review process from having to pay money damages if they are sued (so long as they meet certain conditions). To put it very simply, privileges protect documents; legal “immunities” protect people.
September 20, 2018
QUESTION: What are the responsibilities of our hospital’s Board of Directors (“Board”) with regard to oversight responsibilities of the Medical Staff?
ANSWER: Although it is important to check your state laws and standards set forth by your accrediting organization, a good starting point would be to refer to the Medicare Conditions of Participation (“Medicare CoPs”) pertaining to the Board’s responsibilities, including its oversight responsibilities of the medical staff. For instance, the Medicare CoPs place the ultimate responsibility for quality of care provided at a hospital and monitoring the care provided to patients on the Board. Among others, the Medicare CoPs require the Board to define criteria for and appointing members to the medical staff, grant clinical privileges, ensure the existence and approval of medical staff bylaws, and approve various services in the hospital. Ultimately, the Board holds the responsibility for the quality of patient care in the hospital. The Board and medical staff engage to provide effective credentialing, privileging, and peer review and quality management processes.
Although responsibilities provided by the Medicare CoPs are extensive, do not forget to consult your applicable state laws as well as the standards of your accrediting organization, which may dictate further oversight responsibilities of the Board.
September 13, 2018
QUESTION: We are reviewing an application from a new applicant who has excellent credentials with respect to his education, training, experience and current clinical competence. However, the applicant has had trouble working with others and was even subject to a behavioral performance improvement plan at his last hospital. The Credentials Committee is split over how important behavior really is when a candidate otherwise has excellent credentials. How should we proceed?
ANSWER: This is a question we hear often. You finally find a physician who has excellent credentials, but acts out a little. While everyone has a “bad hair day” once in a while, it is a mistake to bring someone into your organization whose behavior will undermine your culture of safety.
This is the terminology used by The Joint Commission when it issued its 2008 Sentinel Event Alert. According to the Sentinel Event Alert:
“Intimidating and disruptive behaviors can foster medical errors, contribute to poor patient satisfaction and to preventable adverse outcomes, increase the cost of care, and cause qualified clinicians, administrators and managers to seek new positions….All intimidating and disruptive behaviors are unprofessional and should not be tolerated.”
The Sentinel Event Alert was followed by the adoption of a leadership standard that required hospitals to adopt a code of conduct or professionalism policy.
Recognizing the importance of working professionally and respectfully with others, most credentials policies require applicants to demonstrate an “ability to work harmoniously with others, including interpersonal and communication skills sufficient to enable them to maintain professional relationships with patients, families, and other members of health care teams.” The bottom line is that behavior matters in the quality of care you provide in your hospital.
So in credentialing the applicant, get as much information from previous hospitals and past employers about his or her ability to work with others. Ask for a copy of the behavioral performance improvement plan. Ask for a copy of the underlying concerns that led to the adoption of the performance improvement plan. Request a copy of any correspondence that relates to behavioral concerns. And don’t forget to make follow-up phone calls to references and to others who may have worked with the applicant in the past to get a candid evaluation of any problems.
A physician who experienced a problem period because of personal issues, but then improved should not be problematic. A physician with a longstanding pattern of inappropriate and unprofessional behavior is not likely to change when he or she lands at your hospital. Don’t forget the middle option of conditional appointment which can also be useful in laying out expectations and consequences should the inappropriate behavior reoccur.
Please join us in our national program – Credentialing for Excellence – where we discuss this and other credentialing challenges.
September 6, 2018
QUESTION: In July, we added two at-large seats to our MEC. After his first meeting, one new at-large member went to a physician whose behavior was discussed at the MEC meeting (and referred to the Professionalism Committee). The new at-large member told him all about the discussion, including the names of employees who had reported concerns. When I, as Chief of Staff, approached the new at-large member, he said he was just doing collegial intervention. I pointed out that he had signed a peer review confidentiality agreement and that we had discussed confidentiality at his orientation session. He responded that he was elected to represent his colleagues and that it was not fair to discuss someone at the MEC “behind his back.” Should he be removed from the at-large seat?
ANSWER: Removal may be a drastic and potentially disruptive step. Most peer review confidentiality agreements contain a statement that breach of the agreement is grounds for removal, so you could do that. However, you and other leaders may be able to get his commitment to respect confidentiality in the future, and avoid the possible political fallout of removing him. He will need some additional orientation! While authorized representatives of a committee can engage in planned collegial intervention, what he did (acting on his own and divulging the names of individuals who reported concerns) was inappropriate. The MEC referred the matter to the appropriate committee and that process (which typically includes a meeting) should be allowed to proceed. Most importantly, the identities of individuals who reported concerns should not be disclosed. If there is retaliation, there are significant risks to everyone. Moreover, there is a risk of an argument that there has been a waiver of the peer review privilege if this informal unauthorized discussion becomes known. (Hopefully it will not become known.) The new at-large member should be counseled, advised that this cannot happen again and asked to agree in writing to abide by the confidentiality agreement. If he is not willing to agree, then removal may be your only option.
Be sure to join Ian Donaldson and Barbara Blackmond for The Complete Course for Medical Staff Leaders! You’ll get to participate in a meeting of the MEC where many of your most important questions will be answered!
August 30, 2018
QUESTION: What is the latest formal regulatory guidance from the government on how hospitals are to structure a gainsharing program or a compensation arrangement with physicians who assist a hospital with the hospital’s Value Based Purchasing Program (“VBP”)?
ANSWER: Currently, there is none – this is why the responses to the June 25, 2018 CMS Request for Information on the Stark Law and the OIG’s August 27, 2018 Request for Information that is described in this week’s “Government at Work” are so important.
Both OIG and CMS have referenced the HHS “Regulatory Sprint to Coordinated Care.” Both OIG and CMS have recognized that the Fraud and Abuse Laws that are within their jurisdiction (the Stark Law in CMS’s case and the Anti-Kickback Statute and Civil Money Penalty Law (the “CMP”) in OIG’s case) can create real or perceived barriers to achieving clinical and financial integration between hospitals and physicians. What is unfortunate is that in the past neither CMS nor OIG has shown much of a willingness to address those barriers to hospital-physician integration efforts.
As we pointed out to CMS (and also intend to inform OIG), if removing unnecessary governmental obstacles to care coordination is a key priority for HHS, then the planned HHS “Regulatory Sprint to Coordinated Care” will not get off the starting line without significant revisions to the regulations implementing the Stark Law, the Anti-Kickback Statute and the CMP, which are well within the respective discretion of CMS and OIG to implement.
For example, hospitals need immediate guidance concerning the ability of a hospital to compensate physicians who assist the hospital under Medicare’s VBP. It is difficult, if not impossible, for a hospital to achieve the desired goals under the VBP without physician input and cooperation. However, the fair market value of that input and cooperation is difficult to determine and hourly payment rates are often not reflective of the fair market value of the services actually being provided to the hospital by the physicians.
Hospitals need to be assured that utilizing a payment methodology that is based, in whole or in part, on the amount of the payment that the hospital receives under the VBP due to the services provided by the physicians will satisfy an exception to the Physician Self-Referral Law and will not violate the Anti-Kickback Statute or the CMP.
In addition, since 2001, the OIG has provided Compliance Program and Advisory Opinion Guidance on gainsharing arrangements. (See, OIG Supplemental Compliance Program Guidance for Hospitals, 70 Fed. Reg. 4858, 4869-70 (Jan. 31, 2005); e.g., OIG Advisory Opinions 01-01 (Jan. 11, 2001); 05-01 (Feb. 4, 2005); 05-02, 05-03, 05-04 (Feb. 17, 2005); 05-05, 05-06 (Feb. 25, 2005); 06-22 (Nov. 16, 2006); 07-21, 07-22 (Jan. 14, 2008); 17-09 (Jan. 5, 2018). However, no safe harbor exists for gainsharing arrangements.
CMS issued a proposed regulation, Incentive Payment and Shared Savings Programs, on July 7, 2008 (to be codified at 42 C.F.R. § 411.357(x)). However, that proposed regulation did not adequately address VBP and differed significantly from OIG’s gainsharing guidance. Rather than publish a final regulation, CMS asked for public comment on 55 aspects of the proposed regulation. 73 Fed. Reg. 69,725, 69,795-98 (Nov. 19, 2008). Unfortunately, to date, CMS has failed to issue any type of formal (or informal) guidance on the application of the Stark Law to gainsharing or other shared savings programs.
The OIG should turn its gainsharing, compliance and advisory opinion guidance into a safe harbor. While we would prefer a new Stark gainsharing exception, a new Stark exception may not necessary so long as CMS states unambiguously that a hospital that complies with that OIG gainsharing safe harbor will satisfy the personal services exception to the Physician Self-Referral Law.
CMS and OIG should also propose additional, consistent guidance that will address VBP and other shared savings programs. Such a position would be consistent with the position taken by CMS and the OIG in adopting parallel Stark exceptions and anti-kickback safe harbors for providing financial assistance to physicians implementing electronic prescribing and electronic health records (See 42 C.F.R. § 411.357(v)-(w); 42 C.F.R. § 1001.952(x)-(y)) and would provide practical guidance that hospitals and physicians could use to achieve clinical and financial integration.
August 23, 2018
QUESTION: I have always been told that peer review is conducted by peers — so representatives from legal should not be present at peer review meetings. But, recently, I heard a Horty Springer attorney suggest that legal should be called “early and often.” Which is it?
ANSWER: Both! Well, sort of. We have long recommended that collegial meetings between Medical Staff leaders and their colleagues should be “informal” and not include lawyers. “Informal” does not mean that you should not prepare for those meetings (you should have talking points and an objective when you walk into the meeting). However, it does mean that if peer review is going to work best, and practitioners are going to buy-in to the process and believe that it is truly oriented towards helping them succeed, then it has to be conducted with finesse and sensitivity to how interventions will be perceived by those under review. Lawyers do not belong in those meetings. Lawyers add an air of formality, tend to talk when they should remain quiet, and their mere presence can give the impression that the process is adversarial. Any conversation that occurs between doctors will look MUCH different if their lawyers are sitting by their sides. It is for this reason that we have long recommended that the Medical Staff Bylaws and peer review policies of hospitals and medical staffs specifically state that lawyers cannot attend meetings with the practitioner under review (and by the same token, have long told our clients that it would not be advisable for us to be present either).
This does not mean that Medical Staff leaders should not consult counsel early and often throughout the peer review process. Too often, legal is called to assist an MEC after it has just voted to revoke a practitioner’s privileges or the day after a precautionary suspension has been imposed by the Chief of Staff. It can be very difficult for your legal counsel to help you follow your processes precisely — and document your actions in a way that will create the best defense — if called after-the-fact. And waiting to seek advice can result in the leadership sacrificing the chance to pursue additional avenues for resolving the issue (such as automatic relinquishment or a formal performance improvement plan) that may have avoided the need for “disciplinary” action and its attendant costs (such as hearings, appeals, NPDB reports, and litigation).
In an ideal scenario, the Medical Staff leadership would have a close and ongoing working relationship with legal counsel and would discuss with counsel any time there are questions, but at least in the following situations that arise during the course of peer review activities:
- Whenever addressing a peer review matter involving a practitioner who has previously sued the health system, hospital, or any Medical Staff leader
- Whenever the practitioner has retained a lawyer and is using a lawyer to communicate with the leadership
- Whenever the practitioner has claimed failure to comply with the Bylaws or Rules and Regulations or other policies of the Hospital or Medical Staff
- Whenever the practitioner has claimed that the Hospital or Medical Staff leadership has acted unlawfully with respect to peer review activities
- Whenever the practitioner has claimed impermissible conflicts of interest, anti-competitive activity, or discrimination is influencing the peer review process
- Whenever the practitioner claims to be a whistleblower during the course of peer review activity
- Whenever the peer review concerns involve matters with particularly legal significance (e.g., violation of EMTALA or HIPAA or concerns of medical necessity)
- Prior to implementing any precautionary suspension, if possible. If previous consultation with legal is not possible (for example, the issue arises in the middle of the night and is an emergency), legal should be consulted as soon as possible (for example, first thing the next morning)
- Whenever developing a formal Performance Improvement Plan
- Whenever considering whether to commence a formal investigation
- Whenever conducting a formal investigation
- Meetings of the MEC or Board where adverse professional review action will be considered (for example, when the MEC meets to review the report of an investigating committee)
- When conducting a Medical Staff hearing or appeal
- When filing an NPDB report or a report to the state licensure board
- When responding to a subpoena from a licensure board or other governmental agency that is seeking information about a Medical Staff member
- When drafting a reference for a practitioner about whom some “not nice” things will be said
This list is not necessarily exhaustive. But we know from experience that the scenarios listed above have legal implications and Medical Staff leaders can protect themselves (and better serve their colleagues) by seeking advice on how to proceed when handling those tough scenarios. Seasoned leaders often need less guidance, particularly as their experience increases. But, even then it can be helpful for leaders, who are often full-time clinicians — to rely on legal to help with document preparation and identification of applicable Bylaws, policies, and other matters that need to be considered during the course of review.
To conclude — should legal be involved in peer review? Absolutely! With the caveat that meetings with the practitioner under review are meant to focus on peer-to-peer interaction and likely are not the right venue for attorney participation or attendance.
August 16, 2018
QUESTION: What responsibility does the hospital have under the Emergency Medical Treatment and Active Labor Act (“EMTALA”) to stabilize an individual with an emergency medical condition once he/she is admitted as an inpatient at the hospital?
ANSWER: The short answer is that the stabilization obligation under EMTALA is satisfied and ends upon patient admission.
Under EMTALA, it is required that when an individual comes to an emergency department, the hospital must provide an appropriate medical screening examination within the capability of the hospital’s emergency department and, if an emergency medical condition is determined to exist, provide any necessary stabilizing treatment, or an appropriate transfer. However, EMTALA further provides that if the hospital admits the individual as an inpatient for further treatment, the hospital’s obligation to stabilize ends (42 C.F.R. § 489.24(a)(1)(ii)). In fact, the Interpretive Guidelines to EMTALA reiterate that EMTALA does not apply to hospital inpatients. The existing hospital Conditions of Participation protect individuals who are already inpatients of a hospital and who experience an emergency medical condition.
In fact, in a recent case noted in last week’s version of the Health Law Express, Walley v. York Hospital, the court looked to the history of EMTALA and its application to inpatients. Back in 2002, recognizing a difference of opinion among courts, the Centers for Medicare & Medicaid Services (“CMS”) did propose applying the stabilization requirement to inpatients admitted in order to stabilize emergency medical conditions. However, after negative public comments and consideration of federal case law, CMS, in 2003, adopted the version that is now in effect, that the stabilization requirement is satisfied and ends upon patient admission as far as federal remedy is concerned. After reexamining the issue in 2012, CMS once again chose to leave the regulation as it stands. (Walley v. York Hosp., CIVIL NO. 2:18-CV-126-DBH (D. Me. July 27, 2018).)
However, it is important to note that CMS and case law recognize that a hospital must admit an individual as an inpatient in good faith to avoid liability under EMTALA. Specifically, if a hospital did not admit an individual as an inpatient in good faith with the intention of providing treatment, such that the hospital used the inpatient admission as a means to avoid EMTALA requirements, then the hospital is considered liable under EMTALA and actions may be pursued.
August 9, 2018
QUESTION: We recently received a complaint that one of our Medical Staff members was “surfing” the EMR, looking for patients with a certain diagnosis and then contacting them to offer his services. Should we refer this matter to our HIPAA Privacy Officer, review it under our Medical Staff Professionalism Policy, or take some other approach?
ANSWER: There are good reasons for involving the hospital’s Privacy Officer in the review of HIPAA violations by Medical Staff members. The Privacy Officer is responsible for implementing the hospital’s HIPAA policies, so that individual should be aware of potential privacy violations by Medical Staff members. Also, Privacy Officers have significant experience investigating and responding to privacy violations. They will be familiar with HIPAA’s dense regulatory requirements and know how to find information that shows if health information was improperly accessed.
At the same time, there are good reasons for using the Medical Staff process to review HIPAA complaints involving physicians:
- Physicians may be more likely to listen to other physicians.
- Hospital licensing regulations generally require the Medical Staff to review the actions of its members.
- The Medical Staff process is protected by a statutory peer review privilege, which results in confidentiality and candid discussion.
- Violations of HIPAA (or any regulation) may include a behavioral component that will be of interest to the Medical Staff leadership.
To get the best of both worlds, we recommend that the Medical Staff Professionalism Policy include a provision describing how individuals responsible for other hospital policies (such as the HIPAA Privacy Officer or the Corporate Compliance Officer) will be notified of concerns that involve their area of responsibility. The Policy should also describe how efforts will be made to coordinate the efforts of the Medical Staff leadership and the individual responsible for the other policy (e.g., through attendance at meetings and the sharing of information).
For additional information about dealing with physician behavior concerns, please join us in San Francisco for:
August 2, 2018
QUESTION: I was just reviewing a contract to draft a second amendment and noticed that the original contract has the hospital as a party but the first amendment has the hospital’s physician group as a party. What should I do?
ANSWER: This doesn’t happen that often, but it does happen enough. The good news is that it looks like you were watching the details when drafting the second amendment.
In any event, confirm which entity is to be the party in the contract. It may be that the person who drafted the first amendment inserted the wrong party (or, conversely, the person who drafted the original contract had the wrong party). Or, it may be that the contract was assigned by the hospital to the physician group, but you would not know that because the assignment was not included in the package of documents you were given to draft the second amendment.
The correct party is important for compliance reasons – for example, if the contract is supposed to be with an entity that qualifies as a “group practice” under Stark, but is with the hospital, and incentive bonuses include the group’s in-office ancillary services then the contract would violate Stark.
Also important is the issue of liability. The hospital may set up a physician corporation, or limited liability company, to shield the hospital’s assets. If the contract is with the hospital instead of that separate entity, the hospital’s assets are at risk.
Some other details to check are to make sure the entity on the first page is the entity listed in the signature block on the last page. Again, having a different legal entity in the signature block does not happen that often, but it does happen and making sure the entities are the same can save much heartache.
Finally, make sure the employment contract is signed by both parties. An unsigned employment contract could spell trouble from a Stark perspective. For example, although the Stark employment exception does not require a written contract, if an employer wants to take advantage of certain things, such as directing referrals, the contract must be in writing and signed by the physician.
So, make sure to dot those “i”s and cross those “t”s when drafting or reviewing contracts.