Question Of The Week

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)).

July 29, 2021

Posted on by Courtney Patterson

QUESTION:
“We are in the process of reviewing our Medical Staff Bylaws after a long period of neglect. While going over the provisions related to Medical Staff hearings, a Bylaws Committee member suggested that if a practitioner is under precautionary suspension, the hearing should be held within 10 days of the practitioner’s request. Ten days seems like a short time for us to prepare for a hearing. But, a few of the doctors on the committee really felt like it would be most fair to a practitioner whose livelihood is “on hold” to have the hearing occur in the most expedited way possible. What do you think?”

ANSWER:
It’s noble to consider the impact of a precautionary suspension on the practitioner who is affected, but holding a hearing within 10 days of a practitioner’s request will be almost impossible for you to manage, from a practical standpoint. Here’s why:

  • Thirty days is the minimum time you must give the practitioner to decide whether to request a hearing under the Health Care Quality Improvement Act (which provides certain immunities from liability to peer reviewers). Therefore, most organizations’ Medical Staff Bylaws and related documents, like the Medical Staff Credentials Policy, are drafted to give a practitioner 30 days to request a hearing.

Because the practitioner has 30 days to make the request, the hospital never really knows when the practitioner’s request will be received.  The request could come on day one or it could come at the close of business on day 30.  That’s a big window!

This matters because the Bylaws language your Committee member suggested states that you will hold a hearing within 10 days OF THE PRACTITIONER’S REQUEST.  If you don’t know when the practitioner’s request will come in, it will be very difficult to prepare (for example, recruiting hearing panel members who are available to serve).

  • Adding to the complexity here is the fact that the Health Care Quality Improvement Act requires, as a condition of immunity, that the practitioner be given at least 30 days to prepare for the hearing after being provided NOTICE OF THE HEARING. That is, you must give the practitioner 30 days to prepare after you send the notice that includes the time, date, and details of the hearing itself (this is different than the first notice, which tells the practitioner that he or she is entitled to request a hearing).

If a practitioner is subject to a precautionary suspension at the time, he or she may consent to have the hearing held in a shorter timeframe (e.g., 10 days) – but until you obtain the practitioner’s consent, you will not know whether you will be able to hold the hearing within 10 days of the practitioner’s request or, alternatively, after 30 (or more) days.  Again, this lack of knowledge regarding when the hearing may or may not occur will make it incredibly difficult for you to find a hearing panel and schedule the hearing – tasks that are essential to tackle if you are planning to hold a hearing within a 10-day timeframe.

WHAT THIS ADDS UP TO:  Imagine yourself, as a leader, approaching colleagues to see if they would be willing to sit on a hearing panel (which likely would mean giving up at least a couple of evenings and perhaps a couple of working days) – and then telling them that you are not sure when you will need them to do this, but think it will be sometime in the next one to 60 or so days!  It’s difficult enough to recruit a hearing panel member without this level of uncertainty in scheduling.

So, if we can agree that holding a hearing 10 days after the practitioner requests it is not practical, what options exist to provide some expedited assurance of fairness to a practitioner who is subject to precautionary suspension?

  • First, make sure you are considering precautionary suspensions separately from other adverse professional review actions. Try not to lump them all together.  That way, you can expedite the process for reviewing the precautionary suspension (e.g., deciding whether there continues to be an imminent risk to the health or safety of an individual) and, if possible, lift the suspension pending continued inquiry into the underlying matter or work with the practitioner to look for less restrictive alternatives (such as having the precautionary suspension apply to some, but not all, privileges held by the practitioner).
  • Second, in the case of precautionary suspension, provide expedited procedures that are “fair under the circumstances.” These procedures should be outlined in the Medical Staff Bylaws (or related documents, such as the Medical Staff Credentials Policy).  Consider requiring that the MEC meet to review the precautionary suspension within an expedited timeframe (e.g., no more than five or 10 days after the suspension is put in place) to decide whether it should be continued pending further review.  Include an opportunity for the practitioner to meet with the Committee to discuss the concerns and offer input (including suggesting any less restrictive alternatives that might be employed to address the concerns while the review continues – for example, strict compliance with patient selection criteria, the use of a consult/second opinion, etc.).
  • After the above review is conducted, the leadership will determine whether to keep the precautionary suspension in place pending further review. In that case, the Medical Staff leadership should be diligent in proceeding with the review of the underlying matter so that there is not unnecessary delay that prolongs the precautionary suspension period.
  • Finally, if anything changes in the interim, or additional facts are brought to light through the review of the matter, and that changes the assessment of whether an imminent risk exists – it is appropriate for the MEC to revisit the issue and lift the precautionary suspension as soon as plausible.

By way of example, imagine a practitioner was precautionarily suspended after the Hospital learned he had been arrested for harassment of an individual who used to be his patient and who claimed that he continued to stalk her following the end of their relationship.  If you later learned from the police that the charges had been dropped after the patient recanted her story and attested to the fact that their relationship was consensual, the MEC might consider immediately lifting the precautionary suspension (on the basis that the concern of imminent risk has been eliminated), even though it would want to continue its underlying review of the matter (on the basis that a consensual sexual relationship with a patient is nevertheless a concern and ethics violation, even if it does not give rise to a concern of imminent risk).

July 22, 2021

Posted on by Courtney Patterson

QUESTION:
“Over the past several years, our system has created a number of service lines.  Each service line has a physician leader, along with an administrative and nursing leader.  Originally, the focus of the service line was on operational issues.  Now, the physician service line leaders want to be involved in credentialing, privileging, and peer review.  The problem is that our medical staff bylaws don’t mention service line leaders.  What should we do?”

ANSWER:
While most systems have developed service lines using a model similar to the one you described, in our experience, most medical staff bylaws are completely devoid of any reference to the service lines or service lines leaders.  However, it makes no sense for a system’s service lines and its medical staffs to operate in separate silos, especially when there are so many overlapping goals around quality of care and patient safety.  It’s time to act!

We recommend that you start by including references to service lines and service line leaders in your medical staff documents (e.g., bylaws, credentials policy, professional practice evaluation/peer review policy).  Ideally, these documents should reflect the expectation that service line leaders will participate in core medical staff functions, including credentialing, privileging, and peer review.

Your documents should also make it clear that when performing these functions, service line leaders will follow the process outlined in the medical staff bylaws and policies, and that service line leaders are also bound by the same peer review privilege and confidentiality principles.  It’s also important that the medical staff documents expressly allow for credentialing and peer review information to be shared with service line leaders (and vice versa).

The key is to make sure your medical staff documents are not an unnecessary impediment to needed change.  There are likely going to be some challenging discussions about how fully service line leaders should be integrated into core medical staff functions.  But if we keep our focus on doing what’s best for patient care, we will be able to move forward in coordinating service line leaders into medical staff processes and, hopefully, there will be added benefits of improving consistency and uniformity in decision-making throughout the system.

July 15

Posted on by Courtney Patterson

 

QUESTION:
“A physician recently smelled of alcohol and was behaving oddly while conducting rounds.  The physician refused a screening test, so the Medical Staff leadership imposed a precautionary suspension.  Is there a better way?”

ANSWER:
Yes!  First, all hospitals should have a Practitioner Health Policy to govern health issues affecting privileged practitioners.  Such a policy is required if your hospital is accredited by the Joint Commission, and it’s a best practice in any event.  A Practitioner Health Policy allows Medical Staff leaders to identify practices and procedures that work in your setting, and can then be applied in a consistent manner (which helps to avoid allegations of discrimination).

Your Practitioner Health Policy should have a section dealing with responses to immediate threats, such as the one you describe above.  The first step is for the Policy to identify who may respond to handle such situations.  We recommend that a broad group of Medical Staff leaders be authorized to take the steps described in the Policy, to ensure that someone is always available.

The Policy should then identify who, and how many, individuals may request a practitioner to undergo a screening test to identify a possible impairment.  Ideally, two Medical Staff leaders will make such a decision (or a Medical Staff leader and an administrator such as the CMO).  Having two individuals involved in the decision protects them from allegations of bias, and should enhance the credibility of the process in the eyes of the practitioner under review.

To answer your specific question, if the practitioner refuses to cooperate with a screening test, the Practitioner Health Policy should say that the individual automatically relinquishes clinical privileges pending further review by the Leadership Council (or whatever committee handles health issues).  This is not a permanent fix – potentially impaired practitioners would not be permitted to simply move out of town and subsequently harm themselves or others.  Instead, it’s a method of buying time to persuade the practitioner to cooperate with the review process without imposing a suspension.  A suspension causes the situation to feel more confrontational, which sends the wrong message when the goal is to help a colleague.  A suspension also starts the clock ticking for hearings and NPDB reports, which can detract from efforts to constructively deal with the health issue.

For more information about how to deal with practitioner health issues, please join us in Orlando, FL from September 19 – 21, 2021 for the Peer Review Clinic. For more information, click here.

July 8, 2021

Posted on by Courtney Patterson

QUESTION:
“We have an applicant who is refusing to answer one of the questions on our application form because she says that her lawyer told her it could violate a settlement agreement that she has with another hospital.  We think that information is relevant to her request for appointment at our hospital.  Can we still ask for the information?  Should we ask for a letter from her lawyer?  Should the application be held incomplete?”

ANSWER:
Yes!  Credentialers have a duty to review all of the relevant qualifications of each applicant for Medical Staff appointment and clinical privileges and cannot allow the legal interests of an applicant, in an unrelated matter, to interfere with that duty.  Accordingly, the Medical Staff Bylaws (or related policies) should state very clearly that every applicant bears the burden of submitting a complete application and of producing information deemed adequate by the hospital for a proper evaluation of current competence, professional conduct, character, ethics, and other qualifications – and for resolving any doubts.

A similar issue arose in a 1997 case, Eyring v. East Tennessee Baptist Hospital, 950 S.W.2d 354 (Tenn. Ct. App. 1997), in which a physician applicant refused to sign a release form authorizing a hospital where he had previously practiced to send information to another hospital where he had submitted an application.  The physician argued that he received legal advice that signing the release could compromise his lawsuit against the other hospital, which had revoked his privileges.  The court held that because the physician had not provided the additional information that the hospital requested – regardless of the fact that a settlement agreement was in place – he had not submitted a complete application and, thus, under its Bylaws, the hospital was not required to process his application further.

July 1, 2021

Posted on by Courtney Patterson

QUESTION:   “In reference to the case in this week’s HLE, does EMTALA apply to inpatients?”

ANSWER:      The obligations under EMTALA do not apply to a hospital once a patient is admitted as an inpatient in good faith.

However, the issue in the Harmon case was whether the patient had been formally admitted as an inpatient or simply placed in observation. If it is ultimately determined that the patient had been admitted as an inpatient, then he will no longer have a claim under EMTALA, as the Hospital’s obligation to effectuate an appropriate transfer would have ended prior to his attempt to kill himself by jumping out of the car during the transfer to the other facility.

Conversely, if it is determined the patient was put into observation but not admitted as an inpatient, he will be free to pursue his EMTALA claim. This is because CMS has stated that such action does not end a hospital’s EMTALA obligations. This can be found in the Interpretive Guidelines, which state:

“Individuals who are placed in observation status are not inpatients, even if they occupy a bed overnight. Therefore, placement in an observation status of an individual who came to the hospital’s [emergency department] does not terminate the EMTALA obligations of that hospital or a recipient hospital toward the individual.” (Emphasis added)

TAG A-2411/C-2411, Rev. 191,07-19-19

The court in Harmon cites entries in the patient’s medical record that support both arguments (i.e., that the patient was admitted vs. put into observation), so it declined to make a finding on this factual question at this point in the litigation.

June 24, 2021

Posted on by Courtney Patterson

QUESTION:   “Since the new Stark regulations came out late last year, can we still require our employed physicians to refer patients to our hospital or other providers in our health system?”

ANSWER:       Yes.  The amendment to the Stark regulations set forth a separate section on “directed referrals” at 42 CFR §411.354(d)(4) which permits physician compensation in employment relationships, personal service arrangements and managed care contracts to be conditioned on the physician’s referral of patients to a particular provider, practitioner or supplier as long as the physician is paid fair market value, agreement is in writing and subject to the following exceptions:  (i) the patient expresses a preference for a different provider, practitioner or supplier, (ii) the patient’s insurer determines the provider, practitioner or supplier, or (iii) the  referral is not in the patient’s best medical interests in the Physician’s judgment.  The required referrals must relate solely to the services covered by the contract in question.

The regulations go on to say that neither the existence of the arrangement or the amount of compensation can be contingent on the directed referrals.  However, an established percentage or ratio of the physician’s referrals to the designated providers can be required.  In other words, a directed referral provision in an employed physician’s contact could not provide that the physician’s compensation would be cut if the physician does not refer patients to the hospital, but it could require that a certain percentage of the physician’s patients who require hospitalization are sent to the hospital – subject always to the three exceptions.

But beware!  Although the Stark regulation says that personal services arrangements can contain a directed referral requirement, there is no corresponding directed referral language in the Anti-kickback safe harbors.  The only protection there would be the bona fide employment exception, so requiring independent contractors to refer to the hospital would be risky.

Want to know more about this or other provisions in the new Stark regulations? Contact Dan Mulholland or Henry Casale or call 412-687-7677 to schedule an appointment.

June 17, 2021

Posted on by Courtney Patterson

QUESTION:   “We have a mandatory COVID-19 vaccination program for our employees.  If an employee has an adverse reaction to the vaccination, are we required to record it in our Occupational Safety and Health Administration (“OSHA”) 300 log?”

ANSWER:      No, not at this time, but here’s the background.  On April 20, 2021, in its FAQs, OSHA stated that an adverse reaction would be recordable if the injury or illness was work-related (OSHA’s position was that if the vaccine was mandated by employers, it was work-related), it was a new case, and the illness met one of the recording criteria (days off of work, restricted work, medical treatment beyond first aid, etc.).  However, OSHA has since updated its guidance and has stated that at this time it will no longer require employers to record those events since it might disincentivize employers’ vaccination efforts.  OSHA stated that it won’t enforce the rule until May 2022.