Author: hortyspringer

September 6, 2018

Posted on by hortyspringer

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

Posted on by hortyspringer

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

Posted on by hortyspringer

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

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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

Posted on by hortyspringer

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:

The Peer Review Clinic

August 2, 2018

Posted on by hortyspringer

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.

July 26, 2018

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QUESTION:        A physician on our staff has made numerous inappropriate entries into our patients’ medical records. These include scathing critiques of other practitioners and even nasty comments about his patients and their families.  While we have approached him several times to inform him that a patient’s medical record is not an appropriate forum for these comments, he claims he has the First Amendment right to put whatever he wants to in the records, and continues to do so. What can we do?

ANSWER:            Regulatory and accreditation standards make it clear that medical records should only be used to document objective clinical information relative to a patient’s care. Inappropriate editorial statements in a patient’s medical record that are used to be critical of the patient, other providers, or even the hospital itself do not advance the care of a patient and may create increased legal risks to everyone involved in that patient’s care.

A physician who has a complaint or concern regarding the care being provided by any other individual should be advised that the medical record is not the proper forum for addressing those concerns and should then be directed to the appropriate medical staff or administrative channels to report them.   Most times, providing this education and counseling to the physician is sufficient to resolve the issue.  However, if the inappropriate entries continue, then the matter should be referred for review under the medical staff’s Professionalism Policy or Code of Conduct.

Be sure to join Barbara Blackmond and Ian Donaldson for The Complete Course for Medical Staff Leaders, where we will cover practical, real-world approaches to managing unprofessional behaviors that can frustrate even the most experienced medical staff leaders.

July 19, 2018

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QUESTION:        We have two physicians in two different specialties, all four of whom have been willing to take emergency call two days each week, but they have announced that they want their employed advanced practice clinicians (“APCs”) to take their call on weekend days; they are no longer willing personally to take any call on weekends.  ED visits are rare in one of those specialties but common in the other.   Does that comply with EMTALA?

ANSWER:            According to CMS, hospitals must have specialty call schedules that meet the needs of patients in the community.  With only two physicians in any specialty, a reasonable call schedule can be developed with arrangements to transfer patients on the days (known in advance) when those specialists are not on call.  CMS will consider “all relevant factors” in determining compliance, and would expect that the call schedule be based on data showing when patients seek care in the ED for the specialties represented on the medical staff.  Are these specialists on call for their own practices on weekends?  That would be a factor to be considered per CMS.  Another hospital to which patients in need of a specialist on a weekend are transferred might report your hospital, leading to an investigation.  The specialists’ refusal to provide any weekend call thus could put the hospital in jeopardy.  CMS allows APCs to participate in the response to call pursuant to policies adopted by a hospital board.  However, CMS does not permit APCs to be listed on the call roster independently (even if they can practice independently in your state). CMS likely would not accept the inclusion of the APCs on the call schedule in lieu of a physician specialist (despite the newer language in the CMS Conditions of Participation and Interpretive Guidelines calling for APCs to have a greater role on the medical staff).  If a patient presents on a weekend in an emergency medical condition, needing the care of the specialist who employs (and supervises/collaborates with) the APC, the physician would be responsible to come in if the ED physician determines that the specialist is needed personally.  (That could be a condition of the grant of privileges.)  It would be best to convene a working group of physician leaders (including an ED physician), the management team, counsel, risk management and at least one Board member to review data showing when patients present to the ED in need of various specialties, and the relative burden among the specialties on the staff. That group can develop a compliant plan.  The risks are significant so it behooves every organization to develop a policy.

Be sure to join Ian Donaldson and Barbara Blackmond for The Complete Course for Medical Staff Leaders!  We cover EMTALA basics, as well as solutions to common dilemmas, in an entertaining way.

June 28, 2018

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QUESTION:        What happens if a member of our Medical Executive Committee is unable to attend a meeting?  Should we require that member to designate a substitute and, if so, should the process for choosing a substitute be written into our medical staff bylaws?

ANSWER:            Generally speaking, it is usually unnecessary to require members to send a substitute to cover their absence from a Medical Executive Committee meeting.  While you certainly want people to attend and be engaged at meetings, an occasional absence is unlikely to affect matters substantially.

There are also certain drawbacks that come with designating substitutes to attend as alternates in case of an absence.  For example, the substitute must be educated on all of the confidentiality requirements that attach to membership on an important committee.  In addition, the substitute may lack the necessary background and training to understand the full significance of a particular decision (since he or she will only attend the meetings sporadically).  This can potentially lessen the effectiveness of the committee.

If it is especially important for a particular set of views to be represented, you can always invite that person to present his or her perspective to the committee.  To allow for this, we often add language in Medical Staff Bylaws that states:  “Other individuals may be invited to Medical Executive Committee meetings as guests, without vote.”  This gives you the option to bring in others as necessary, but does not mandate that a substitute cover every absence.

 

June 21, 2018

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QUESTION:        A physician who has been on our staff for only a few months has been experiencing complications, with several cases falling out.  So, as part of the initial FPPE, I (as the new Service Line Chief) called this physician into a collegial intervention meeting. He showed up with the head of his group practice, who is not a member of any medical staff committees. When I said that the meeting was a confidential peer review meeting, both physicians left. Now what? Was I right or did I miss an opportunity?

ANSWER:            You are correct that collegial intervention meetings are confidential and that individuals who are not members of an authorized peer review committee should generally not be present. All medical staff members have an obligation to work constructively and cooperatively in the peer review process. This should be covered in new physician orientation, as well as in a statement of expectations that is provided to applicants (and also sent along with the letter of appointment, to be signed by the newly appointed physician).

However, a new medical staff member, especially one who is right out of training, may not be aware of or understand the requirements for Focused Professional Practice Evaluation for all new privileges and may be fearful that collegial intervention is actually a disciplinary step. That’s why it’s important for leaders to emphasize the nature of collegial intervention and performance improvement. Of course, leaders engaging in collegial intervention must be authorized by a peer review committee structured in a manner to fall within the protections of the applicable state peer review law.

There may be times when participation of a respected physician mentor who could serve as moral support for a new physician might make sense, with certain safeguards. You could consider telling the new staff member that he may be accompanied by the head of his group, so long as the head of the group signs a peer review confidentiality agreement. Some state peer review laws explicitly cover group practices as well as hospital medical staff committees; and, in some health systems, information sharing policies encompass affiliated group practices.  This would offer added protection.  (You may also want to be accompanied by another authorized leader, perhaps a vice chief or chair of the peer review committee.)

The purpose of a collegial intervention meeting is to emphasize that the medical staff leadership strives to help all physicians be successful so long as they are willing and able to do what it takes. Leaders may need to remind the head of the group of the expectations for all members, and educate the head of the group who may have had no leadership experience, about the peer review process and the applicable regulatory and accreditation standards.  If both are willing to participate constructively, this approach may help de-escalate the situation.

Join us for The Complete Course for Medical Staff Leaders in San Francisco, as we help new leaders understand their roles and prepare for success.