Question Of The Week

October 21, 2021

Posted on by Courtney Patterson

QUESTION:
We are trying to implement care guidelines for hip and knee replacements across the system.  The leadership has agreed on the guidelines generally and is now discussing implementation and enforcement.  They want to monitor the established metrics through the OPPE process and, if a practitioner is outside the metrics, have them automatically referred for FPPE (the matter would be referred to the Medical Staff peer review committee for further review and a determination of what collegial measures, if any, could be taken to get the practitioner into compliance).  If the practitioner remains outside the metrics cutoff after 90 days, the leadership has recommended that the practitioner’s joint replacement privileges be deemed automatically relinquished for failure to comply.  This method of enforcement does seem a whole lot easier than conducting an investigation and going through all of the procedures that are necessary to revoke privileges.  What do you think?

ANSWER:
While it is true that implementing an automatic relinquishment is easier than conducting an investigation, making an adverse professional review recommendation, and/or conducting a hearing and appeal process, not every situation is well suited to automatic relinquishment.

The situations where automatic relinquishment is most appropriate are those that are objectively assessed, require little to no evaluation of the practitioner’s competence or conduct, and tend to be focused on administrative requirements.  For example, failure to comply with documentation requirements, failure to attend a meeting when requested by the Medical Staff leadership, or loss of licensure are all matters that routinely lead to automatic relinquishment within hospitals/medical staffs all across the country.

There are some situations where failure to follow a protocol or guideline could appropriately lead to implementation of automatic relinquishment.  For example, consider the scenario where a hospital and medical staff establish a clinical protocol requiring a practitioner to either comply with the protocol or, alternatively, document contemporaneously in the file the reason why he or she is not following the protocol.  Automatic relinquishment of privileges for failure to comply with the administrative requirement of documenting the reasons for non-compliance would be acceptable, since the evaluation of the matter would be objective (e.g. did the practitioner comply?  If not, was there documentation of why in the chart?).  Further, the relinquishment would be related to an administrative matter (failure to comply with a documentation requirement applicable when not complying with a protocol).

However, if the practitioner were being reviewed because, although he or she was documenting the reasons for not following the protocol, the Medical Staff leadership felt those reasons were not good – that would be a different matter.  That would involve evaluation of the practitioner’s clinical judgment (e.g., the explanations for why the protocol was not followed), which would require subjective evaluation, clinical expertise, and a judgment about the practitioner’s clinical competence and/or conduct. Because of that, the consideration of whether the practitioner was justified in not following the protocol would better lend itself to review under the Medical Staff professional practice evaluation process (which is specifically designed to evaluate performance issues utilizing the expertise of the Medical Staff leaders and, afterwards, implement collegial solutions to help practitioners improve).

The situation you describe sounds like it may be more akin to the latter situation described above, in which case automatic relinquishment would not be the best solution.  It’s true that words like “guidelines” and “metrics” give the initial impression that a matter is being objectively evaluated – and that can lead many to believe that automatic relinquishment is a viable option for all situations involving failure to comply.  Our suggestion is to focus more on the actual metrics that are under consideration.  Is non-compliance with those metrics measured objectively, without the need to consider the explanation of the practitioner (e.g. H&P was on the chart prior to surgery, surgical note was on the chart prior to surgeon leaving the OR)?  If the metrics are “administrative” in nature, like these, then automatic relinquishment may be the right enforcement method.

But, if non-compliance with metrics is measured objectively at first –and then requires subjective evaluation to verify whether non-compliance was justified (e.g. patient was an appropriate candidate for the procedure, diagnostic tests were appropriate, appropriate medications were given), then review through the peer review process may be a better option than resorting to automatic relinquishment.  In your scenario, since the original plan is to refer matters of non-compliance into the FPPE process, it sounds like your guidelines may require subjective evaluation and be less “administrative” and, in turn, less suited to automatic relinquishment.

Of course, as always, the best option is to consult with your in-house or Medical Staff counsel, as the best answer depends on the specific protocols/guidelines you are looking to implement and enforce, as well as the language of your Medical Staff Bylaws and related governance documents.

October 14, 2021

Posted on by Courtney Patterson

QUESTION:
What should be done if an applicant for reappointment is under investigation but his current term of appointment is set to expire before the investigation is completed?

ANSWER:
As most know, the Joint Commission has made it clear that privileges are granted for a period not to exceed two years and that continuations or extensions are not appropriate.  While this rule likely came about to avoid routine extensions due to administrative failures to process reappointments in a timely manner, it makes situations like the one above difficult to manage.

Keeping in mind this two-year limitation, we’ve found the best way to address applicants for reappointment who are currently under investigation is through a short-term conditional reappointment pending the outcome of the process.  This keeps the hospital on the right side of the Joint Commission, while providing time for the investigation to work its way out.

Having language in your Medical Staff Bylaws documents to support this approach is a key to good credentialing.

October 7, 2021

Posted on by Courtney Patterson

QUESTION:
In June, a federal court dismissed claims brought by employees of Houston Methodist Hospital who alleged the hospital’s vaccination requirement was illegal.  In this past week, another federal judge dismissed a similar lawsuit brought by employees of St. Elizabeth Medical Center.  How many hospitals/health systems have a mandatory vaccination requirement?

ANSWER:
As of September, approximately 2,600 hospitals and health systems put in place a mandatory vaccination requirement.  There were also over a dozen states, and even several cities, that imposed the requirement on health care workers.  There were some requirements that had exemptions for medical or religious reasons, and the penalties for not being vaccinated ranged from suspension to termination to weekly testing, among other things.  So, the requirement is on the upswing, and we’re staying alert for any updates.

September 30

Posted on by Courtney Patterson

QUESTION:
As we are preparing for a medical staff hearing, a member of our Medical Executive Committee asked why our Medical Staff Bylaws state that the Chief Executive Officer appoints the hearing panel and not the Chief of Staff since it’s the Chief of Staff who knows most of the members of the medical staff.  We are trying to figure out whether this was a typo or not.  Should the Chief of Staff appoint the panel?

ANSWER:
No – that’s not a typo!  While we do still sometimes see bylaws which assign the Chief of Staff the responsibility to appoint the hearing panel (and worse yet, occasionally it’s the whole Medical Executive Committee that does so), it’s long been our recommendation that the CEO or the CMO fulfill that responsibility – in consultation with the Chief of Staff.

This is because, generally speaking, the Chief of Staff, both in his/her role as a Medical Staff officer as well as a member of the MEC (the body that will most often be making the adverse recommendation that triggers a hearing) tends to be someone who is very intimately involved in the underlying matter that led to the hearing.  The Chief of Staff will frequently be the individual who engaged in collegial intervention and other progressive steps with the affected physician, who was involved in the development of any conditions or restrictions and, ultimately, is involved in the adverse recommendation made by the MEC as the chair of that committee.  When an involved Chief of Staff is then responsible for appointing the hearing panel and presiding officer, we have seen the argument made that the selections were biased in favor of the MEC and are not neutral – which can lead to objections and legal challenges (both before and after the hearing) to the appointment of the panel.

While we know that these claims are largely groundless, it is very important to manage the appearance of fairness at all steps of the hearing process.  The goal is to isolate the volunteer physician leaders – like the Chief of Staff – from these types of claims and allegations as much as possible, which is why the CEO or CMO should appoint the panel after consulting with the Chief of Staff.

September 16, 2021

Posted on by Courtney Patterson

QUESTION:
We’re developing new case review forms for our peer review process and wondered whether we should ask reviewers to assign a numerical score to various aspects of care.  Do you recommend scoring cases in this way?

ANSWER:

No!  In our experience, scoring has the following drawbacks:

(1)        Too much energy is spent assigning the score, which distracts from the most important questions:  Is there a concern with the care provided, and if so, how can that concern be addressed?

(2)        Numerical scores can’t capture the complexity of a case in the same way as a longer narrative.

(3)        Physician reviewers may be uncomfortable assigning low scores which indicate that care was “inappropriate” or “below the standard,” especially if those scores are accompanied only by short statements such as “care below the standard.”  As a result, they choose higher scores indicated “care appropriate” even if there are concerns.

(4)        Scores may put physicians on the defensive, especially since most scoring systems don’t allow for the provision of nuanced information.

These characteristics of scoring can undermine efforts to make the peer review process educational rather than punitive.  Accordingly, we recommend having a peer review/professional practice evaluation (“PPE”) system that focuses on actions and performance improvements rather than scoring.

September 2, 2021

Posted on by Courtney Patterson

QUESTION:
“How many hospitals are requiring COVID-19 vaccinations?”

ANSWER:
Answer:  In our podcast in June, we stated that “more and more” hospitals were requiring the vaccine, noting first and foremost Houston Methodist Hospital, where the vaccine mandate was challenged by employees but was ultimately upheld in federal district court.  Also at that time, most hospitals in Washington D.C., the 6 hospital University of Pennsylvania Health System, and Community Health Network in Indianapolis, among others, required vaccinations.

Since then, a few things have happened to alter the landscape one way or another, such as the Food & Drug Administration approving the Pfizer vaccine, some states passing laws that prevent mandatory COVID-19 vaccines (Benefis Health System was going to require vaccinations before Montana passed a law preventing the mandate), and the Delta variant ripping through the country.

In any event, according to the American Hospital Association, around 1,500 hospitals currently require vaccinations, which it states is around 25% of hospitals in the country.  As for whether this number will go up – we’re going to say “more and more” hospitals will require the vaccine.  “May you live in interesting times” – sure, but not this interesting.

August 26, 2021

Posted on by Courtney Patterson

QUESTION:
“One of our medical staff members asked if, under the Health Insurance Portability and Accountability Act (“HIPAA”), he can inform a patient he is currently treating about the cancer history of a former, deceased patient who was a family member of the current patient.  The physician believes that this information will assist the patient in making choices about the direction of her treatment.  Can he do that?”

ANSWER:
The HIPAA Privacy Rule protects “individually identifiable health information,” which is defined to include a patient’s past physical health condition.  Thus, the deceased patient’s cancer history meets this definition.  However, since the patient is deceased, is the information still protected under the HIPAA Privacy Rule?  The answer to this question is “yes.”  The HIPAA Privacy Rule protects individually identifiable health information of deceased patients for 50 years following the date of the death of the individual.  Assuming the patient hasn’t been dead for 50 years, the patient’s individually identifiable health information is subject to the protections of the HIPAA Privacy Rule.

That being said, it is certainly important that a patient understand his/her family history, including risks for certain diseases and disorders so that he/she can proactively address those risks.  Here, the treating physician’s hands aren’t completely tied when it comes to counseling the patient on such matters.  He has a few options.  The physician can rely on an exception to the HIPAA Privacy Rule, which permits the disclosure of protected health information for treatment activities.  According to guidance issued by the United States Department of Health and Human Services, the “treatment” exception “allow[s] use and disclosure of protected health information about one individual for the treatment of another individual.”  If the physician is concerned that counseling on a family member’s cancer history does not definitively meet the definition of “treatment” under HIPAA, he has other options.  First, and most obviously, the physician can ask the patient if she is aware of any family history of cancer.  If not, the physician can obtain a written HIPAA authorization from a personal representative (e.g., the deceased patient’s executor or administrator) to disclose the information.  If the physician is unable to obtain a written authorization for whatever reason (such as an inability to locate the personal representative) or believes this is too burdensome, the physician can still make treatment recommendations without disclosing health information protected under HIPAA.  For example, the physician may recommend more frequent cancer screenings based on the family history to which he is privy.

August 19, 2021

Posted on by Courtney Patterson

QUESTION:
“Sometimes people who come to our ED simply leave without telling anyone if they have to wait any length of time. Are we on the hook for an EMTALA violation when that occurs?”

ANSWER:
Generally, you are not.  EDs are busy places and individuals may have to wait for care behind others based on priority and other factors.  Some individuals may decide to leave and seek care elsewhere.  That, in and of itself, is not an EMTALA violation.  However, there are several instances where CMS has cited hospitals for “coercing” an individual to seek treatment at another facility.  This type of activity – whether done directly by telling the individual they would be better off going somewhere else, or indirectly by routinely keeping people in the ED waiting so long that they get frustrated and leave– could create risk for the hospital.

However, assuming those types of activities are not in play, the best thing to do when an individual leaves the ED without being seen is to document the individual’s departure as soon as it is discovered and keep any other documentation that may have been created based on any interactions with the individual before he or she left.

August 12, 2021

Posted on by Courtney Patterson

QUESTION:
“What about those surprise billing rules?  We heard they aren’t effective until January 1, 2022.  Should we be doing anything now to prepare?”

ANSWER:
The Surprise Billing Rules are a big deal!  And there are steps you can take to be prepared for January 1, 2022.

On July 13, 2021, the Departments of Health and Human Services, Labor, and Treasury published an interim final rule implementing certain provisions of the No Surprises Act, which was enacted as part of the Consolidated Provisions Act of 2021.  Effective January 1, 2022, the interim final rule affords patients protection against balance billing and cost sharing for certain out-of-network services, prohibits out-of-network providers and health care facilities from balance billing patients under specific circumstances absent notice and consent, requires providers to disclose federal and state patient protections against balance billing, and sets forth complaint and dispute resolution processes for patients, payers, and provides to address potential violations of the protections against balance billing and cost sharing under the No Surprises Act.

Among other protections, the Interim Final Rule prohibits balance billing for non-emergency services furnished at an in-network facility by an out-of-network provider, absent notice and consent.  In addition, out-of-network providers may only bill the patient such cost-sharing amounts similar to what the patient would pay had they received those services in-network.  This restriction includes out-of-network charges for ancillary services (e.g., radiology, anesthesiology, pathology, cardiology, and emergency medicine) provided at in-network facilities.  Any charges left over, however, may not be balanced billed to the patient.

In anticipation of these rules taking effect, you should review your hospital-based provider contracts.  If the contracts are silent on how those providers can bill patients, you could build language into the contracts requiring the provider to contract with every health plan that the hospital contracts with.  You can also put language in the contact prohibiting the out-of-network provider from balance billing.

This is one of several issues hospitals should be considering in preparation for the surprise billing rules’ January 1, 2022 effective date.  For more information on the Surprise Billing Rules, tune in to our audio conference. If you have any questions, or if you would like help reviewing your provider agreements, feel free to reach out to Mary Paterni at mpaterni@hortyspringer.com.

August 5, 2021

Posted on by Courtney Patterson

QUESTION:
“Can you provide a quick guide to the Stark Value-Based Exceptions?”

ANSWER:
While these Rules are difficult to summarize and the devil is in the details, the following is a summary of the Stark Value-Based Rules that became effective on January 19, 2021:

A Value-Based Arrangement is intended to compensate the physician Value‑Based Participants of a Value Based Enterprise for achieving the Value‑Based Purposes of the Value-Based Activity for a Target Patient Population, rather than basing that payment on the items or services furnished by the physicians.

CMS stated in the Preamble to the January 19, 2021 Rules that the anticipated benefits from the Value-Based Rules are to:  improve care coordination for patients; reduce cost to payers and patients from poorly coordinated, duplicative care; improve quality of care and outcomes; achieve substantial reduction in Stark Law compliance costs; and reduce administrative complexity and related waste.

Whether the Value-Based Rules will achieve any or all of these benefits remains to be seen.  What is clear is that the Value-Based Rules have requirements that are significantly different from the requirements in fee-for-service arrangements that were governed by the Stark Rules that have been previously in effect.  The Value-Based Rules have different requirements depending on the level of financial risk assumed by the physician Value-Based Participants.

The Stark exceptions for Value-Based Arrangements went into effect on January 19, 2021 and are found at § 411.357(aa)(1)-(3).  While each Value-Based Exception needs to be considered to determine which will apply,  there are several elements that all of the exceptions have in common: (i) the Value-Based Definitions found at 42 C.F.R. § 411.351; (ii) as the Value-Based Enterprise (“VBE”) and/or VBE participants increase the financial risk assumed, the applicable Stark Value‑Based Exception will allow for increased flexibility; (iii) the traditional definition of Fair Market Value is not required by any of the Stark Value-Based Rules; (iv) the remuneration to the VBE participants cannot constitute an inducement to limit services; (v) the remuneration to the VBE participants cannot be conditioned on the referral of patients who are not part of Target Patient Population; (vi) if remuneration is conditioned on referrals to a particular provider, then the referral arrangement must be in writing, signed by the parties, and must include the three exceptions contained in the Stark directed referral rules; and (vii) records of the compensation methodology used must be retained for six years and provided to HHS upon request.

The Stark Rules then categorize the Value-Based Exceptions based on the level of financial risk assumed with the greatest flexibility provided to a VBE that accepts Full Financial Risk which means the Value-Based Enterprise is responsible on a prospective basis for the cost of all patient care, items and services covered by the applicable payor for each patient in the Target Patient Population for a specified period of time (such as accepting capitation).

The next greatest amount of flexibility is permitted for Value-Based Arrangements with meaningful downside risk to the physicians.  Meaningful Downside Financial Risk requires the physicians to be responsible to repay or forego no less than 10% of the Total Value of the remuneration the physician receives under the Value-Based Arrangement.  Examples of this model provided by CMS in the Preamble to the January 19, 2021 Rules include:  a $50,000 payment, plus $25,000 for Value-Based Activities as long as the entire $25,000 is conditioned on achieving a specified Value-Based Activity for a Target Patient Population; and a $100,000 payment with a $20,000 withhold, so long as the withhold is only payable upon completing the Value-Based Activities for the Target Patient Population.

There is also a Value-Based Exception in which the Physicians are not placed at financial risk.  This is referred to in the regulations as the Value-Based Arrangements Exception, 42 C.F.R.  § 411.357(aa)(3).  This exception protects remuneration paid to the physician participants in the Value-Based Arrangement regardless of whether it is in cash or in kind.  However, due to the fact that the physicians are not at financial risk and are not required to be paid at Fair Market Value, this exception has the most detailed regulatory requirements of any of the Stark Value-Based Rules.

In addition to the terms described above, this exception requires that the Value-Based Arrangement must be set forth in writing that is signed by the parties and describes: (i) the Value‑Based Activities to be undertaken; (ii) how the Value-Based Activities are expected to further the Value‑Based Purposes of the Value-Based Enterprise; (iii) the target patient population; (iv) the type or nature of remuneration; (v) the methodology that is to be used to determine that remuneration; and (vi) the Outcome Measures against which remuneration is assessed.

CMS also requires that at least annually, or at least once if the arrangement is in effect for less than one year, the Outcome Measures must be monitored to determine: (i) whether the parties have provided the Value-Based Activities required by the Value-Based Arrangement; (ii) whether and how the continuation of the Value-Based Activities will further the Value-Based Purposes of the VBE; and (iii) the progress toward the attainment of the Outcome Measures against which the recipient of the remuneration will be assessed.

If this monitoring determines that the Value-Based Activity is not expected to further the Value‑Based Purposes of the VBE, then the VBE has two options in order to maintain compliance with the Stark Law:  (1) terminate the arrangement within 30 consecutive calendar days of the date of completion of the monitoring indicating that the Value-Based Activity was ineffective; or (2) modify the Arrangement to terminate the ineffective Value-Based Activity within 90 consecutive calendar days of completion of the monitoring and, if they choose, replace that Value-Based Activity with a different Value-Based Activity with prospective applicability.

While several differences exist between the Stark Value-Based Exceptions and the OIG Value‑Based Safe Harbors that also went into effect on January 19, 2021, this exception is the greatest point of departure from the OIG Value-Based Safe Harbors (42 C.F.R. § 1001.952(ee)-(kk)).  If a physician is not at financial risk, then the OIG Safe Harbors only protect in-kind remuneration.  (As stated above, the Stark exception protects remuneration in the form of cash or in-kind services.)  That said, payments of cash remuneration in a non-risk setting (such as a cost‑sharing arrangement) may be protected by the amended personal services and management contracts and outcomes-based arrangements safe harbor that was added by the January 19, 2021 Safe Harbor Regulations (see 42 C.F.R. § 1001.952(d)(2)).