Question Of The Week

December 20, 2018

Posted on by hortyspringer

QUESTION:        What we’d like to get as a present this year is a way to find strong, interested and effective department chairs and other Medical Staff leaders.  Any ideas?  Thanks – Virginia.

ANSWER:            Yes Virginia, there is a Santa Claus – in other words, yes, we have a few ideas.  Let’s start unwrapping the present.

In many hospitals, it has been traditional to rotate the department chair among those in the department so that everyone gets his or her turn, which does not always make for strong, interested, and effective leaders.  However, not every physician has an aptitude for, or interest in, a medical staff leadership position.  In order to solve this dilemma, a hospital should consider developing stronger qualifications for serving in medical staff leadership roles, including officers as well as department chairs, and to provide for compensation for these individuals.  Another solution could be to determine whether there are too many departments and, if so, consider consolidating departments.  By having fewer positions to fill, the hospital will then have a larger pool of qualified individuals who want to serve.

All of this said, one of the biggest changes that we have seen in medical staff leadership in the recent past is to eliminate the use of “ad hoc” nomination committees for identifying medical staff leaders – whether the leaders be officers, department chairs, or committee chairs — and moving toward a standing committee dedicated to leadership development and succession planning that meets throughout the year.  Having a standing committee in place allows the leadership to take a more comprehensive look at the medical staff, identify new members who might make good leaders in the future, and give them time for training, education, and development.

For more on this, and other topics, please join Linda Haddad and Nick Calabrese for the first Grand Rounds Audio Conference of 2019 — Six New Year’s Resolutions Every Medical Staff Needs to Make.

December 13, 2018

Posted on by jwilbert

QUESTION:        We recently asked a physician to meet with our Leadership Council (a small group of Medical Staff leaders) to provide input regarding a concern about his behavior.  He says he’ll be happy to attend the meeting, but only if accompanied by his attorney.  Our policies do not address this issue – do we have to let the attorney attend the meeting?

 

ANSWER:            No.  The meeting is not a hearing.  It’s simply an opportunity for physicians to talk with one another in a collegial manner.  There’s no legal obligation to permit an attorney to attend, and the presence of an attorney would likely make the process less effective by making it seem more confrontational than it needs to be.

It’s much easier to address this situation when the applicable policy includes language such as the following:

  • To promote the collegial and educational objectives of this Policy, all discussions and meetings with a Practitioner shall generally involve only the Practitioner and the appropriate Medical Staff Leaders and Hospital personnel.  No counsel representing the Practitioner, Medical Staff or Hospital shall attend any of these meetings.

Of course, the physician may consult an attorney prior to the meeting (and the physician shouldn’t be discouraged from doing so).  The attorney can even accompany the physician to the hospital and wait in an appropriate location, if the physician insists.  But there’s no obligation to allow the attorney to accompany the physician during the meeting.

For more ideas on handling difficult peer review issues, check out our Peer Review Clinic.

December 6, 2018

Posted on by hortyspringer

QUESTION:        A certain medication has gotten to be so expensive that our hospital has decided to stop stocking it.  As a result, we will not be able to treat certain patients.  The drug company that manufactures this medication has offered to provide the medication to the hospital FREE of charge, although it is our understanding that insurance will cover the drug after the patient is discharged.  This seems to us like a win-win.  Surely the government cannot object to such an arrangement.  Is this legal?

 

ANSWER:            Unfortunately, the Office of Inspector General cares a great deal about an arrangement such as the one that you have described and has recently opined that under certain circumstances a manufacturer providing an expensive drug free of charge to a hospital could violate the Medicare Anti-Kickback Statute.

The Anti-Kickback Statute prohibits any form of remuneration, in cash or in kind, that is provided with the intent to induce the referral of business that is paid for in whole or in part by a federal health program such as Medicare or Medicaid.  The free drug is remuneration under the law.  In OIG Advisory Opinion 18-14 (posted Nov. 16, 2018), the OIG opined that under the circumstances presented, the free drug could constitute an unlawful inducement and prohibited the arrangement.

Why?  The drug at issue had multiple uses, one of which was to treat a particular syndrome.  Once started, the drug had to be tapered or the patient would suffer serious side effects.  Most insurance, including the Medicare program, will pay for the drug on an outpatient basis.  However, when provided to a hospital inpatient, the cost of the drug was included in the hospital’s DRG payment.  At the current price of $38,892 per vial, many hospitals have decided that they could not afford to stock the medication.

The drug manufacturer’s response was to offer to provide the medication to hospitals free of charge while the patient was an inpatient.  Because the medication was covered on an outpatient basis, the drug company could be paid for the medication following discharge.  However, if the patient’s insurance would not cover the medication on an outpatient basis, the manufacturer would continue to provide the medication free of charge until either insurance coverage is obtained or the patient is tapered off of the medication.

Why did the OIG object to such a program when in the past the OIG has approved several arrangements in which drug manufacturers provided free medication to financially needy outpatients?  In order to answer that question, you need to examine how the OIG viewed this particular arrangement.

Typically, the OIG limits its review in an Advisory Opinion to the facts that are submitted by the entity requesting the opinion.  However, in this opinion, the OIG took the unusual step of considering publicly available information.  The OIG noted that the drug at issue was not new and that at one time it cost only $40.  The OIG also noted that at its current price of $38,892 per vial, the drug “has the highest total annual spending per use and the highest price per unit among drugs that CMS examines that met certain criteria.”  The OIG also considered the fact that the drug manufacturer had entered into a $100 million settlement with the FTC of an antitrust claim that was alleged to stifle competition for this medication.

The OIG also considered the fact that insurance, including Medicare, covered the drug on an outpatient basis.  Also important to the OIG was the fact that the program did not consider the financial need of the recipient.  The manufacturer only provided the drug at no cost on an outpatient basis if the patient had no insurance coverage for the medication and then only until insurance coverage could be obtained or the patient could be safely tapered off of the drug.

This led the OIG to conclude that providing the medication for free to hospitals “could function as a seeding arrangement.”  The OIG noted that the full course of treatment typically extended beyond the patient’s hospital stay.  Factors such as the length of the treatment, the fact that alternatives to the medication exist, and the need to taper the medication in order for the drug to be discontinued led the OIG to conclude that the manufacturer’s intent appeared to the OIG to be to induce hospitals to start patients on this medication while an inpatient, so that the manufacturer would eventually be paid for the drug after the patient was discharged.  The OIG was also concerned that providing the medication free to hospitals would steer patients to this medication as opposed to other medications that could be used to treat the syndrome.

These facts caused the OIG to determine that such an arrangement could violate the Medicare Anti-Kickback Statute and, as a result, the OIG would not approve the proposed arrangement.

If you want practical examples as to what is and what is not permitted by the federal fraud and abuse laws, join Henry and Dan in New Orleans from April 11 to 13 for the Physician-Hospital Contracts Clinic.

November 29, 2018

Posted on by hortyspringer

QUESTION:        We recently received an application from an internist who has moved around a bit more than normal in his nine years of practice (post-training).  Though our application form asks applicants to list all institutional affiliations since the completion of training,  along with starting and ending dates, we have found that this applicant left out two prior employers and four prior hospitals where he held privileges and, further, have found that four of the starting/ending dates that were listed on the application are off by three to six months.

After asking the applicant about the discrepancy, he corrected the application, said that he could not recall exact months when he started or ended a couple of his affiliations, but was piecing it together the best he could from memory, and said he was sorry that he had not given the application more personal attention the first time around.  He further explained that the omission of information from the application was the result of his relying on someone else to fill out the application, in this case, the office manager of the practice that he recently joined.  He said that he gave her his CV to use for reference when filling out this application (along with managed care and malpractice insurance enrollment forms), but now realizes that his CV omits a few workplaces where he spent only short periods of time and did not really develop a significant practice. He invited us to call with any additional questions.

He seems cooperative and this all seems like a fairly legitimate explanation. Do we need to do anything else?

ANSWER:            The most common explanation for missing or incorrect information on an application form?  You got it: “My office manager filled out the form.”  In our experience, Medical Staff leaders are often quite forgiving when faced with such explanations.  And sometimes, that is reasonable (see above introduction, regarding how even a type-A personality attorney can forget the details about her parent’s anniversary!).  But, sometimes, a simple explanation such as this can be a cover for a remarkable history.  It is the hospital’s and medical staff leaders’ job to find out which situation you are facing anytime there is an omission or misrepresentation.  Good policies can help make the process of following up more methodical and easier to implement.

First, note that some hospitals and medical staffs make it a general practice to simply inform the applicant of a discrepancy in information on the form (versus what has been verified by the Medical Staff office) and then give the individual an opportunity to correct the form!  This is generally not a good practice because it basically serves as a “free pass” to any applicant to lie at the outset and then later correct the form, without consequence, if caught in the act.

A better practice is to address all omissions and misrepresentations that are discovered during credentialing in writing addressed to the applicant.  Policies should state that misrepresentations and omissions can be grounds for the hospital or leadership to stop processing the application or, if the individual has already been appointed or granted privileges at the time the misrepresentations or omission is discovered, can be grounds for automatic relinquishment upon notice to the practitioner.

Without good policy language, Medical Staff leaders who discover omissions or lies on application forms (or any other information provided during the course of the credentialing process) can be left with little recourse but to deny the application based on the individual’s ethics (or overlook the misrepresentation because they don’t want to deal with a denial and the hearing and appeal rights that it brings).  This is too much risk to assume on the part of someone who was not honest and forthcoming about his or her qualifications.  Therefore, it’s important that the Bylaws or Credentialing Manual specify how applicants will be informed of omissions and misrepresentations discovered during the course of credentialing, the opportunity they will be provided to explain, how the explanation will be considered, the consequences of any misstatements or omission, and whether any rights to meetings or due process will apply (we generally suggest that they do not).

If you would like more tips for managing applications that include incomplete, incorrect, or unusual information, join us this spring at a Horty Springer seminar covering best practices in credentialing applicants with unusual histories:

Strategies for Managing Physician Health and Disruptive Conduct

The Strategies Seminar provides an engaging opportunity for hospital and Medical Staff leaders to cultivate a sophisticated understanding of the legal and practical complexities that come into play when the most difficult credentialing and peer review issues arise — specifically, those involving practitioner health, disruptive conduct, and conflicts of interest. By working through case studies and complex scenarios, this course will help participants navigate the land mines that can arise when health, conduct, and conflicts are at issue. Experienced faculty will guide participants to develop problem-management strategies that reduce legal risk, help colleagues, and, most importantly, protect patients.

New for the 2018/19 seminar season: Credentialing Dr. Angle. She’s got skills that you’d like to have.  But she’s also got an unusual application and it’s just so darned hard to nail down the details.  How deep do you really need to dig when, on the surface, the applicant seems so great?

Credentialing for Excellence — Advanced Tools and Techniques

The Credentialing Seminar provides comprehensive training for those involved in all levels of the credentialing process. The seminar is designed for hospital and Medical Staff leaders, Medical Staff professionals, and Board members. Attendees will leave the three-day seminar with the skills and knowledge they need to manage the risks involved in credentialing and to use the credentialing process to establish excellence in the provision of care in their institutions. The seminar is interactive, engaging and thought-provoking so that attendees will get the most out of their experience.

November 15, 2018

Posted on by hortyspringer

QUESTION:        If we decided to implement standardized personality tests across our institution, would this raise any legal concerns?  Does the EEOC have any guidance on this?

ANSWER:            Personality tests raise significant legal concerns and should be approached cautiously.  Although it is becoming increasingly common to see personality testing as a standardized part of job screening, the federal Equal Employment Opportunity Commission (“EEOC”) has raised concerns that such testing can have unlawful discriminatory impacts.  For example, the EEOC recently reached an agreement with CVS following a probe over whether the drugstore chain’s use of personality tests had a negative impact on jobseekers based on their race and/or national origin.  (See here for the EEOC press release.)

The exact nature and extent of the legal risk vary depending on how the test is designed and administered.  As a general rule, any employer who uses a personality test (or similar selection procedure) should be prepared to justify its use under close scrutiny.  Even if a test is administered without any intent to discriminate, it might still have an unlawfully disproportionate impact on a protected class of people (for example, disproportionately excluding people based on race, religion, sex, or other protected factors).  Employers must have strong evidence showing that the selection procedures/tests are job-related and consistent with business necessity and should be confident that their evidence can persuade skeptical regulators.

Unless you have well-documented empirical evidence to defend the use (and necessity) of a particular personality test, we would generally encourage you to avoid this kind of screening.

November 8, 2018

Posted on by hortyspringer

QUESTION:        Is a subpoena from a state board of medicine treated just like any other subpoena for purposes of the Health Insurance Portability and Accountability Act (“HIPAA”)?  In other words, is it true that the hospital can’t release a patient’s Protected Health Information to a state board of medicine unless it first takes certain steps, such as getting a qualified protective order from a court, or informing the patient?  Thanks.

ANSWER:            No, a subpoena from a state board of medicine is not treated like any other subpoena for HIPAA purposes.  Protected Health Information (“PHI”) which is the subject of such a subpoena can be released to a state board of medicine without a qualified protective order or notice to the patient.  HIPAA provides that PHI may be disclosed to a “health oversight agency” for “licensure or disciplinary actions” necessary for oversight of the health care system.  (45 C.F.R. §164.512(d).)  HIPAA also states that a state board of medicine is a “health oversight agency.”  (45 C.F.R. §164.501.)  That said, if certain categories of particularly sensitive information are involved (such as mental health, drug/alcohol, or HIV/AIDs), state law should be consulted to see if it offers greater protections to the information.

November 1, 2018

Posted on by hortyspringer

QUESTION:        We are considering having a Credentials Verification Organization (“CVO”) perform primary source verification and other required verifications for our credentialing process.  Do we need to have some sort of agreement in place?  If so, what should that agreement include?

ANSWER:            Regardless of whether you are using an internal CVO (i.e., one that is a part of your organization) or an external, independent CVO (i.e., one that has no corporate affiliation with your hospital), there should be an agreement in place between the CVO and the hospital.

An agreement should define the obligations of the CVO, including the services that it will provide.  The agreement should also specifically identify the information that will be verified and the sources that will be used for verification purposes.  If ongoing monitoring of practitioners’ credentials is a part of the services the CVO will provide, the agreement should state this and indicate the credentials that will be monitored (e.g., Medicare and Medicaid sanctions and exclusions).

Furthermore, sharing of confidential credentials information should be addressed and include provisions on how sensitive information such as National Practitioner Data Bank reports and drug or alcohol treatment information will be handled and shared.  If the hospital is involved in delegated credentialing for third-party payors, there are special considerations for sub-delegation agreements, which would include agreements with an external CVO to perform verification activities.

Specifically, the agreement must require semiannual reporting of the CVO to the hospital on its conduct of the contracted-for activities, describe the process by which the hospital evaluates the CVO’s performance under the agreement, and describe the remedies available to the hospital if the CVO does not fulfill its obligations, including revocation of the delegation agreement.

October 25, 2018

Posted on by hortyspringer

QUESTION:        We recently received an application from a nurse practitioner who crossed out the line on our application form asking for the name of the collaborating/supervising physician and wrote that he didn’t have a collaborating physician because our state allows nurse practitioners to practice independently.   Is this true?  Do we have to change our forms and process?

ANSWER:            It depends, but probably not.  A state’s decision (through modification of the professional licensing statutes and regulations) to expand the scope of practice for an advance practice nurse, and to allow such practitioners to practice independently in that state, does not generally supersede the policy decision of a hospital that such practitioners must still work in collaboration with a physician appointed to the medical staff in that hospital setting.  The only exception would be if the changes in the state law were to actually “mandate” that such practitioners be permitted to practice independently — in all clinical settings.  In our experience, with a handful of exceptions, this is not what most states have done, at least not yet.

While it may be a question that the medical staff and board wish to consider further, there is a significant difference between a statute that permits independent practice and one that mandates independent practice.  If the hospital policy continues to require a collaborative relationship, this applicant should be informed that he or she is ineligible to apply unless he or she can supply evidence of a collaboration agreement with a physician.

October 18, 2018

Posted on by hortyspringer

QUESTION:        Our hospital has adopted a mandatory flu vaccine policy for all employees and our MEC thinks it makes sense to also require vaccines for all private practice providers who are credentialed at the hospital.  What is the best way to do this?

ANSWER:            This question seems to be coming up often — another sad reminder that the summer season has transitioned to the flu season!  Many medical staff leaders see the value in addressing this issue consistently across all providers, regardless of whether they are employed or not.

The simplest solution would be to modify your eligibility criteria in your Medical Staff Bylaws or Credentials Policy so that every applicant and medical staff member would be required to provide evidence of an annual influenza vaccination.  Of course, any exemptions in your hospital’s policy for employees could also be recognized (i.e., allowing providers to wear a mask whenever they are in the hospital if, for example, a medical condition would prohibit them from obtaining a vaccination).

Have other medical staff questions?  Then join Barbara Blackmond and Ian Donaldson for The Complete Course for Medical Staff Leaders, where we will cover practical, real-world approaches to managing all types of Medical Staff leadership dilemmas, including how to modernize the eligibility criteria in your Medical Staff Bylaws.

October 11, 2018

Posted on by hortyspringer

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QUESTION:    Our peer review process uses a case review form that asks physicians to score cases:

1 is  “exemplary care,”
2 is “meets the standard of care,”
3 is “below the standard of care,” and
4 is “significant deviation from the standard of care.”

It seems most of our cases end up being a 2, even when there are concerns.  Is there a better way?

 

ANSWER:      Yes!  Ditch the scoring, and adopt a new form that focuses on narrative explanations to answer three key questions:

(1) is there a concern?;
(2) if so, what’s the nature of the concern?; and
(3) how can the concern be addressed?

One problem with “scoring” cases (or otherwise categorizing them) is that the focus of the review becomes assigning a score rather than fixing any concerns that are identified.

Also, physician reviewers may be uncomfortable indicating that a physician’s care was “below the standard of care.”  As a result, they choose a more favorable score even if there are concerns.

If reviewers are willing to say that care falls “below the standard” or was “inappropriate,” the physician who receives the score is more likely to be on the defensive.  This undercuts efforts to make the peer review process educational rather than punitive.

For more tips on how to make your peer review process more effective, join us in San Francisco from Nov. 15-17 for The Peer Review Clinic.