Year: 2022

March 10, 2022

Posted on by Courtney Patterson

QUESTION:

Is the “No Surprises Act” in effect?  I heard that a court enjoined it.  Is the No Surprises Act limited to Emergency Care?  Can you give me an example of how the Act works?  What recourse do I have if I do not agree with the amount that the insurer pays me under this Act?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY HENRY CASALE:
The No Surprises Act and its implementing regulations (the “Act”) have been in effect since January 1, 2022.  The Act prohibits emergency department physicians and the facility from billing a patient an out-of-network fee for emergency care provided at any hospital Emergency Department and, if permitted by your state, any free-standing emergency department, regardless of whether the hospital or emergency department physicians participate in the patient’s insurance network.

The Act also prohibits balance billing a patient for non-emergency services provided in an in-network hospital by certain out-of-network physicians, including all traditional hospital-based physician specialties.  A physician can get a patient’s waiver of their rights under the No Surprises Act by using the notice and consent form provided by CMS for (1) certain non-emergency services and (2) post-stabilization services.  However, out-of-network physicians cannot obtain waivers for non-emergency services provided at an in-network hospital if they provide traditional hospital-based ancillary services (such as pathology), diagnostic services (including lab and x-ray); services provided by hospitalists, assistant surgeons, or intensivists; or if there are no in-network physicians on the hospital’s medical staff who can provide the care needed by the patient.  The waiver will also not apply to any emergent conditions that arise during a non-emergency service to which the patient provided his/her consent and waiver to be balance billed.

This section of the Act is best exemplified by one of the questions and answers provided by CMS’s Center for Consumer Information & Insurance Oversight:

Rhonda is a 50-year-old female with employer-sponsored health insurance who discovers a lump in her breast.  Her primary care provider orders a mammogram, which shows a suspicious mass. She is referred to the local in-network hospital’s outpatient department for a biopsy.  The biopsy is reviewed and found to be negative for malignant cells by a pathologist who happens to be out of network.

How much can the pathologist bill Rhonda under the rules of the No Surprises Act? 

ANSWER
Under the No Surprises Act, the pathologist is banned from billing Rhonda more than the in‑network cost-sharing amounts, as determined by her health plan.  The pathologist, as an ancillary service provider, is banned from obtaining consent from the individual to waive these balance billing protections.

In the past, the pathologist could bill the out-of-network patient his/her usual and customary charge.  The patient would submit the bill to her insurer and the insurer would pay the provider the out-of-network rate and the pathologist could then balance bill the patient for any amount not covered by insurance – NO MORE.  The No Surprises Act regulations also prohibits the pathologist from obtaining the patient’s consent to waive these rights (although, as described above, certain other specialties can obtain the patient’s waiver for (1) certain non-emergency services and (2) post-stabilization services).

As stated above, the pathologist cannot bill the patient more than the pathologist would bill the patient if the patient was in-panel.  The pathologist must then bill the insurance carrier.  If the pathologist is not happy with the amount paid by the insurer, the pathologist must negotiate with the plan for 30 business days.  If the pathologist is still not happy with the amount being offered by the plan, the pathologist must go to arbitration to determine the amount of payment.

However, on February 23, 2022, a federal court has enjoined the CMS provider/health plan arbitration process (but only the arbitration process – the rest of the No Surprises Act regulations are in full force and effect).  That arbitration process created a presumption that the amount that the provider should be paid is the “Qualified Payment Amount” (“QPA”), which is typically the median rate the insurer would have paid for the service if provided by an in-network provider or facility.

The regulations also limited the information that can be presented to the arbitrator and specifically prohibited the arbitrator from considering the provider’s usual and customary charges for an item or service, the amount the provider would have billed for the item or service in the absence of the Act, or the reimbursement rates for the item or service under Medicare or Medicaid.  Finally, the arbitration is “baseball-type” arbitration, which means that the arbitrator must pick one of the amounts proposed – the arbitrator does not have the discretion to split the difference or to choose an amount other than the amount proposed by the provider or by the health plan.

The federal court enjoined this arbitration process from going into effect.  However, the court did not provide any guidance as to how disputed fees are to be resolved while this case is on appeal, or how payment disputes are to be resolved until new regulations are promulgated.

March 3, 2022

Posted on by Courtney Patterson

QUESTION:
Has The Joint Commission (“TJC”) issued new Elements of Performance (“EPs”) regarding obstetrical/maternity care?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY NICHOLAS CALABRESE:
Yes, TJC issued these new EPs in the early days of the pandemic, so it’s not surprising that these may have received little attention.

The new EPs are under the Provision of Care (“PC”) chapter, at PC.06.01.01 and PC.06.01.03, and were effective July 1, 2020.  TJC’s press release stated that the EPs were implemented because maternal morbidity and mortality was becoming worse, especially in the areas of maternal hemorrhage and severe hypertension/preeclampsia.

The new EPs require assessments regarding hemorrhage and hypertension/preeclampsia risk on admission to labor and delivery and on admission to postpartum.  These EPs also require that the quality improvement committee establish criteria that trigger reviews for such cases, and that the reviews evaluate the effectiveness of the hemorrhage response team.  There are also requirements that education be provided to patients and families regarding signs and symptoms of postpartum hemorrhage and severe hypertension/preeclampsia.

The Medical Executive Committee is also involved, since it is required to assign a multidisciplinary committee the task of developing procedures to manage pregnant and postpartum patients who experience maternal hemorrhage, and for measuring and managing blood pressure to lessen the likelihood of harm relating to maternal severe hypertension and/or preeclampsia.

So, this may be a good time to update your rules and regulations to make sure that these new EPs are covered.

February 24, 2022

Posted on by Courtney Patterson

QUESTION:
Last week we had a 35-week pregnant patient present to our emergency department in active labor.  Her obstetrician was not on our medical staff and the on-call obstetrician was contacted to come in.  In the course of the phone call between the ED physician and the on-call obstetrician, the obstetrician realized that she knew this patient, and she informed the ED physician that she had treated her in the past but had terminated that physician-patient relationship the previous year because the patient had been noncompliant in connection with her previous pregnancy and related complications.  The on-call physician didn’t want to come in to treat the patient because she had gone through a formal process of sending the patient a letter, with the required advance notice, and didn’t want to reestablish that relationship.  Does the on-call physician really have to see a patient in this situation? It seems unfair.

OUR ANSWER FROM HORTYSPRINGER ATTORNEY LEEANNE MITCHELL:
Unfortunately, yes.  While it’s not a popular answer and it does seem unfair from the perspective of the obstetrician at issue who likely did everything required of her to formally terminate that physician-patient relationship – a process that usually requires written notification with at least 30 days’ advance notice (and sometimes longer in the case of a pregnant patient) – the Emergency Medical Treatment and Active Labor Act (“EMTALA”) requirements trump the fact that the obstetrician terminated the physician-patient relationship.  In this case, the obstetrician is responding to the ED as the on-call physician, and she has to respond.

In the absence of a statute like that in effect in Virginia, which specifically provides that a physician-patient relationship created by a response to the ED by an on-call physician is “deemed terminated” upon the discharge of the patient from the ED or, if the patient is admitted, upon the patient’s discharge from the hospital and the completion of any follow-up care prescribed by the on-call physician, the obstetrician will likely have to go through the advance notice and termination process again.

The situation would be different if this patient presented to the ED and told the ED that the obstetrician was her treating physician.  In that case, when the ED contacted the obstetrician to inform her that one of her patients was in the ED, the obstetrician would have been able to inform the ED that she had terminated the physician-patient relationship, and the ED would then have resorted to contacting the on-call obstetrician.

February 17, 2022

Posted on by Courtney Patterson

QUESTION:
We would like to give our physicians backpacks and laptop cases that include our hospital’s logo with the intent that they use these items when traveling to and from work.  The backpack and laptop case would total $225 per physician.  Does this count as remuneration under Stark?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY MARY PATERNI:
The short answer is – yes.  If a hospital provides remuneration to a physician, then the arrangement must satisfy an exception to Stark.  Remuneration is defined broadly under the law, and gifts such as backpacks and laptop cases will likely count as such.  But don’t fret.  The first step is recognizing remuneration.  The second step is finding out whether an exception applies!

There are several exceptions from which we can choose to address these gifts.

First, Stark exceptions offer the most flexibility for gifts offered to employed physicians.  42 C.F.R § 411.357(c).  Most gifts, such as backpacks, that are provided to an employed physician qualify as employee fringe benefits.  Such benefits are covered under the bona fide employment exception under Stark.  If the physicians who are receiving these backpacks and laptop cases are employed, you would not have to record this as a non-monetary compensation under the law.

Assuming that the physicians are not employed, the “non-monetary compensation” exception under Stark allows for compensation in the form of gifts so long as these gifts do not exceed an annually adjusted amount for each Calendar Year.  42 C.F.R. § 411.357(k).  For Calendar Year 2022, the annual non-monetary compensation exception limit is $452.  You can find the annual changes to the compensation amount here.

Please keep in mind that, in order for this exception to count, the hospital must record all items and gifts provided by the hospital to the physician.  In addition, the decision to give such gifts must not be based on, or take into account, the volume or value of referrals or business generated by the referring physician and may not be solicited by the physicians.  It appears that the amount for the backpacks and laptop cases per physician would fit within the non-monetary compensation exception, assuming no other items or gifts were already provided to the physicians that could tip the scale of compensation over the limit.  Just be sure to keep track of the value of all non-monetary compensation provided to each of your physicians for each Calendar Year.

In light of the COVID-19 public health emergency, there is still a blanket waiver in effect for the non-monetary compensation limit that allows remuneration from a hospital to a physician in a form of non-monetary compensation that exceeds the limit for the Calendar Year.  The remuneration covered under the COVID-19 blanket waivers must be solely related to COVID-19 purposes, which may include, but is not limited to, (1) ensuring the ability of health care providers to address the patient and community needs due to the COVID-19 outbreak and (2) ensuring the ability of health care providers to address patient and community needs due to COVID-19.

February 10, 2022

Posted on by Courtney Patterson

QUESTION:
We have a physician who was brought in through a contract with a locum tenens company.  Within the first couple of weeks, he had several horrible outcomes in cases.  We started to review his cases through our peer review process and we are considering a precautionary suspension.  Our CMO just told us that the hospital has instructed the company that the physician can no longer be scheduled at our hospital.  This will result in the termination of his clinical privileges.  Should we suspend his privileges anyway, continue with our peer review process, and then report him to the National Practitioner Data Bank?  We are concerned that he is just going to go someplace else and hurt patients again.

OUR ANSWER FROM HORTYSPRINGER ATTORNEY SUSAN LAPENTA:
We understand the desire to follow your peer review process, especially when there are serious concerns about the clinical care provided by a physician.  The peer review process is, by design, thoughtful, deliberative, and educational with built-in collegial efforts, progressive steps, and, when needed, opportunities for improvement.  As successful as the peer review process can be, it is not well suited to address concerns about physicians who are brought into practice on a temporary basis.

That does not mean you should ignore those concerns.  However, your medical staff may not be in the best position to evaluate, address, and resolve the concerns identified in a physician who is practicing at your hospital on a temporary basis.  In fact, once the hospital has exercised its rights under the contract with the locum company and instructed the company not to schedule the physician again, there is not much left for the medical staff to do through its peer review process.  It difficult to review a physician’s care when the physician is no longer practicing at the hospital and there is no action left to take after the physician’s appointment and privileges have been terminated through the contract with the locum company.

In fact, this is an area where the National Practitioner Data Bank, through its Guidebook, has been very clear.  If a physician’s clinical privileges are terminated as a result of a contract, that termination is not an adverse professional review action and should not be reported to the Data Bank.

If you are concerned that the locum company is going to turn around and place the physician in another hospital, you may want to put the company on notice of your specific concerns.  The company should have a process for evaluating the care and competence of the physicians and other practitioners it is placing.  But be careful what you say to the locum company.  Your communication with the company may not be protected under your bylaws, or state or federal law.

To protect yourself, request the locum company to have the physician sign an authorization and release so that information about the physician’s practice can be shared.  Additionally, if you receive a request from another hospital who is seeking to privilege this physician, you can request an authorization and release before providing any information, including the standard “name, rank, and serial number.”  A request for an authorization should send a message that there are issues that require further review and evaluation.

February 3, 2022

Posted on by Courtney Patterson

QUESTION:
What’s all this I hear about “appropriate use criteria” that Medicare will use to determine payment for outpatient imaging?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY DAN MULHOLLAND:
The Protecting Access to Medicare Act of 2014 (a/k/a “PAMA”) established a new program to increase the rate of appropriate advanced diagnostic imaging services provided to Medicare beneficiaries.  Examples of such advanced imaging services include:  CT, PET and MRI scans.  Under this program, at the time a practitioner orders an advanced diagnostic imaging service for a Medicare beneficiary, he/she, or clinical staff acting under his/her direction, will be required to consult a qualified Clinical Decision Support Mechanism.  CDSMs are electronic portals through which appropriate use criteria can be accessed.

The program won’t go into effect until January 1, 2023 or the January 1 after the current public health emergency ends, whichever is later.  And it only applies to services in a physician’s office, hospital outpatient department (including the emergency department), an ambulatory surgical center or an independent diagnostic testing facility and whose claims are paid under the physician fee schedule, hospital outpatient prospective payment system or ambulatory surgical center payment system.  So (at least for now) it does NOT apply in critical access hospitals.

For more information, check out the CMS website.

January 27, 2022

Posted on by Courtney Patterson

QUESTION:
How should our hospital document services provided to patients whose biological gender and gender identity differ?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY HALA MOUZAFFAR:
Separate fields in the electronic medical record (“EMR”) could be used to properly address patients whose current gender identity does not match their biological sex, with one field capturing birth sex and a second gender identity. Every EMR system may not have this option in its present state, but EMRs certified under the federal Promoting Interoperability Program must have the capacity to record this data.

There is currently no federal rule that mandates hospitals collect information regarding a patient’s gender identity, but gathering both birth sex and gender identity as demographic factors can be helpful to the hospital and patients in several instances.

For example, a patient whose gender identity does not match their biological sex may not have updated legal documentation to reflect their current identity.  In this case, inputting the patient’s gender identity into the EMR in place of sex could result in the patient’s claims getting denied because the information does not align with what is on file with the insurance company.  Additionally, these demographic factors can influence treatment.  For instance, a patient who has a cervix should be offered a cancer screening regardless of gender identity.  By collecting both demographics, hospitals can ensure that claims are approved and allow providers to be aware of potential health problems they may not have otherwise been.

January 20, 2022

Posted on by jwilbert

QUESTION:

Our hospital has granted clinical privileges to practitioners who work primarily in outpatient facilities which are a part of the same health system as the hospital.  How do we conduct FPPE to confirm competence and OPPE for these practitioners when they have limited to no volume in the hospital, but the hospital wants them to retain their privileges in case it needs them to provide patient care services?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY CHARLIE CHULACK:

During the COVID-19 pandemic, this is an important question because hospitals are scrambling for methods to cover the clinical needs of an influx of patients when there are community spikes in infections and hospitalizations.  Thus, they may want to have practitioners “at the ready” even though their primary practice location is not in a hospital.

Nonetheless, you do have some options when it comes to these “low volume practitioners.”  To use The Joint Commission terminology, for “focused professional practice evaluation” (or “FPPE”) to confirm competence and “ongoing professional practice evaluation” (or “OPPE”), the hospital can have the low volume practitioner provide one or more of the following types of information:  (1) information from their primary practice location, such as ongoing professional practice evaluation reports, a quality profile, and/or patient satisfaction surveys, (2) detailed reference requests from their primary practice location, (3) detailed peer evaluations from individuals who have directly observed or who are in a regular referral relationship with the practitioner, or (4) medical records of patients treated at the primary practice location so that the hospital may conduct an evaluation of the care provided.

If the low volume practitioner works almost exclusively in outpatient settings, the above information, if part of a general request, may not address their clinical skills in a hospital setting.  But, you can structure the requests so that the information received relates to the clinical privileges that the practitioner has in the hospital.  For example, while not completely analogous, if the primary practice location is an Urgent Care Center for a practitioner seeking or granted clinical privileges in emergency medicine, the information requested could target the performance of histories and physicals, the ordering and interpretation of diagnostic studies, the administration of medications, and the requesting of consultations/making of appropriate referrals.

For those hospitals that are accredited by The Joint Commission, keep in mind the FAQ issued on March 4, 2021, which provides as follows:  “When practitioner activity at the ‘local’ level is low or limited, supplemental data may be used from another CMS-certified organization where the practitioner holds the same privileges.  The use of supplemental data may NOT be used in lieu of a process to capture local data.”  Thus, The Joint Commission requires that at least some of the data used to confirm competence come from the hospital conducting the evaluation.  The Joint Commission gives hospitals significant flexibility in the type of information collected by the hospital for professional practice evaluation, so you can be creative.

We should mention that for health systems that have outpatient locations operating as departments of the hospital (i.e., as provider-based outpatient departments), then any FPPE or OPPE that was completed in that outpatient setting would be viewed as having occurred “in the hospital.”  In this case, The Joint Commission requirements would be satisfied based on what was done in the outpatient setting.

Another tool to deal with low volume practitioners is to grant an exception that permits them to remain subject to FPPE to confirm competence for the duration of the Practitioner’s appointment term for some or all clinical privileges.  This option may be used because of community need, coverage requirements, the rare nature of a given procedure or treatment, or other relevant factors.  We believe this is a reasonable interpretation of the relevant standards based on the needs of hospitals during the COVID-19 pandemic.

January 13, 2022

Posted on by Courtney Patterson

QUESTION:
We’ve had a question raised about a Medical Staff member who performed a test on a family member without going through the formal patient registration process.  What can we do to educate our medical staff about the risks involved with these kinds of practices?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY IAN DONALDSON:
We have found it to be helpful to set forth guidelines that remind Medical staff members of the concerns that can arise when a physician treats him or herself, a family member, or others with whom the physician has a close relationship.  A good starting spot is the Standard E-8.19 in the American Medical Association’s Code of Ethics, which speaks to how such actions can compromise professional objectivity and unduly influence medical judgment.  In addition, your state medical board may have guidance on this issue.

Relying on these resources, Medical Staff leaders can then adopt policy language that reinforces the standards of acceptable medical practice in these situations.

January 6, 2022

Posted on by Courtney Patterson

QUESTION:
Our peer review committee is wondering if the name of the physician under review should be redacted so that committee members are not aware of the physician’s identity.  Would this promote a fair review process?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY PHIL ZARONE:

While at first blush it might seem like a good idea, we do not recommend that the “blinding” of reviews be part of the peer review/professional practice evaluation (“PPE”) process.  Here’s why:

  • This practice could actually create unnecessary legal risk because it makes it more difficult to manage conflicts of interest. If a disqualifying conflict of interest exists between a committee member and the physician under review, the blinding of information might prevent this from being identified early on.  As such, there could be an allegation later that the committee member actually knew the identity of the subject physician but was deliberately not recused.
  • Obtaining input from the physician under review is an essential component of a fair and effective process. While this input is generally written, there are times a meeting is beneficial as well.  While you could probably shield the identity of physicians when they submit written comments, of course it would be impossible to do so for meetings.  Thus, physicians would be treated differently depending on whether a meeting was held or not.
  • If blinding of information is a component of the peer review process but members of the committee determine the identity of the physician in some cases (e.g., because they heard of a certain case or because there is only one physician in a certain subspecialty), it could lead to allegations by an unhappy physician that the committee violated its policy/practice because the committee knew the identity of that individual. It could be alleged this is “proof” that the committee members were biased in their review.
  • It would take a tremendous amount of careful work to attempt to blind reviews consistently and we think it is impractical on a day-to-day basis. It would stress the PPE specialists (i.e., those who support the review process) more than is necessary, distract them from assisting the process in other and better ways, and all for no great gain.
  • Despite everyone’s best efforts, it is exceedingly difficult to do this completely and ensure anonymity. In many cases, committee members will still know the identity of the physician subject to review.
  • There may be times when the committee members want to access a portion of the EHR during deliberations, which would clearly reveal the identity of the physician.

•   Once the case at issue is assessed, it is then critical for the committee members to know the physician’s history, personality, circumstances, etc.  This information will help the committee identify the most appropriate performance improvement tool (e.g., collegial counseling, educational letter, etc.) and who should be involved.