March 31, 2022

QUESTION:
We just heard that HRSA ran out of money for its Claims Reimbursement Program for COVID-19 Testing, Treatment, and Vaccine Administration for the Uninsured.  Does that mean we can balance bill for services to patients who would otherwise have been reimbursed under this program?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY DAN MULHOLLAND:
Yes, to the extent that you have not already been reimbursed for HRSA.  HRSA recently posted the following announcement on its website:

The Uninsured Program has stopped accepting claims for testing and treatment due to lack of sufficient funds.  Confirmation of receipt of your claim submission does not mean the claim will be paid.  No claims submitted after March 22, 2022 at 11:59 pm ET for testing or treatment will be processed for adjudication/payment.

On April 5, 2022 at 11:59 pm ET, the Uninsured Program will also stop accepting vaccination claims due to a lack of sufficient funds.

The terms and conditions for the Program state in part:

The Recipient certifies that it will not engage in “balance billing” or charge any type of cost sharing for any items or services provided to Uninsured Individuals receiving a COVID-19 testing and/or testing related items, vaccination or care or treatment for a positive diagnosis of COVID-19 for which the Recipient receives a Payment from the Uninsured Program Fund.  The Recipient must not sell or seek reimbursement from an Uninsured Individual for any COVID-19 vaccine and any adjuvant, syringes, needles, or other constituent products and ancillary supplies that the federal government provides at no cost to the Recipient.  The Recipient shall consider Payment received from the Uninsured Program Fund to be payment in full for such COVID-19 testing and/or testing-related items, vaccine administration, care, or treatment.

To the extent that HRSA will no longer reimburse for these services, you can once again balance bill for these services.

March 24, 2022

QUESTION:
I am the chief of the division of family medicine at my hospital.  I recently learned that a nurse’s aide complained to her supervisor about my tone when speaking with the mother of a patient in our clinic.  The complaint made its way into the peer review system, and I was sent a “letter of guidance” referencing the organization’s Code of Conduct and encouraging me, for lack of a better explanation, to be on my best behavior and be mindful of my reputation and that of the health system.

To be honest, although I am involved in leadership and understand the underlying motivation for the Code of Conduct, I found this to be a really patronizing experience.  The aide who made the complaint knows nothing about my history with this patient and his mother, nor the practical or clinical reasons why I might take a serious tone with her.  My treatment of this patient and his mother was appropriate, given the circumstances and I feel pretty strongly that the aide should have stayed out of it or at least raised her concerns with me before reporting me to her supervisor.

I would like to take this opportunity to discuss this situation with the aide and her supervisor.  It’s important for the aide to understand that some patients of the clinic are well known by clinic staff to require more intense interactions regarding appropriate treatment options and the importance of compliance with the treatment plan.  I am not expecting an apology from the aide as a result of this conversation but, instead, see this conversation as an opportunity to improve how the clinic team operates and, hopefully, prevent frivolous reports in the future.

Last week, I approached the supervisor regarding this, to schedule a time for all three of us to sit down to talk (me, the supervisor, and the aide).  The supervisor told me that my plan was not appropriate and could be viewed as intimidation.  She refused to schedule the session and said I’d better run my plan past the Chief of Staff first.  I did and she said it’s better to “leave it alone.”

Has the whole world gone crazy?  Can’t professionals talk to each other anymore?  How is this supposed to improve the patient care environment?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY RACHEL REMALEY:
It’s easy to see why you might be frustrated, given the scenario you have described.  A key component of any peer review process should be transparency.  This means all practitioners who are subject to the process should understand that it exists and how it works.  Information should, ideally, be periodically pushed out to members of the Medical Staff to help them understand the many moving parts to the peer review process.  When the process is better understood, practitioners are less likely to feel targeted when their own practices come under scrutiny.

Transparency requires more than knowledge of the process, however.  It also requires practitioner involvement in their own peer review.  In your case, it appears as though the peer review of the concern involving your conduct was concluded without anyone ever asking for your input and getting your side of the story.  How can practitioners be expected to buy-in to a process that does not include their input?  As you describe it, that input may have been vital in deciding the appropriate outcome.  Maybe if you had been given a chance to discuss the facts with those conducting the review, they would have concluded that rather than sending you a letter of education, they should provide additional information and training to clinic personnel regarding tough, non-compliant patient management.

At this point, what’s done is done.  Your best bet may be to respond to the letter of education explaining your side of the story and requesting that consideration be given to obtaining your input should any future, similar concerns be reported.  Further, you might consider recommending that clinic personnel receive additional training to help them understand and manage situations like this.  Don’t worry that your response will be seen as controversial or adversarial.  A professionally-worded response, sent through appropriate channels, is part of the review process and is completely appropriate.  After all, the aim of the peer review process should not only be to work with privileged practitioners to address concerns that are under their control, but also to bring to light related, systemic concerns that should be addressed to improve patient care overall.

With that said, we agree with the aide’s supervisor that it is not a good idea for you to sit down with the aide to discuss this matter.  While doing so might be the fastest, most efficient way to get from point A to point B, the supervisor is right – your actions could intimidate the aide.  And, in the long run, that could lead to aides (and other personnel) being reluctant to report meaningful concerns about practitioners due to fear of retaliation.

This advice may be frustrating, because your intentions may be good.  Instead of focusing on your intentions, though, try to think about process.  Can an effective peer review process rely on the good intentions of every physician whose conduct is reported?  If practitioners are given free rein to “confront” those who report concerns about that, would that have a chilling effect on future reports?  Would that promote advancements in quality?

You can see where we are going with this.

Ideally, this issue would have been addressed with you earlier (when your input was first sought by the leadership reviewing this matter) and, at that time, the organizational definition of retaliation could have been provided, along with a caution about engaging in any conduct that could be viewed as retaliatory.  Our recommendation is that a professionalism policy include any contact with the individual who filed a report, in an attempt to discuss the matter, as retaliatory – no matter the intention.  Letting practitioners know this early in the process avoids any embarrassment or confusion later.  Further, bringing it up early in the process avoids an implication that the practitioner is pursuing retaliatory conduct and allows it to serve as a generalized, non-confrontational FYI.  In most organizations, it works well and keeps disputes (and retaliation) to a minimum.

Peer review is tough and imperfect. Organizations are constantly tweaking their processes to correct deficiencies and improve the experience for the practitioners who are subject to review.  We hope you can take the flaws you perceived in this review of your conduct and work through available channels at your organization to suggest appropriate changes (e.g., earlier, methodical request for the practitioner’s input and guidance to practitioners of who they can contact to discuss the matter).

March 17, 2022

QUESTION:
Our hospital’s medical staff is working on a policy to screen older practitioners at reappointment for health issues that may affect their clinical ability.  A member of the MEC was previously at a hospital with a similar policy in place. She has spearheaded the effort and noted that her previous hospital’s policy was able to detect health issues with three elderly physicians.  While the preliminary discussions have been overwhelmingly positive, a couple of our physicians in their 70s voiced dissent with the policy at the last full medical staff meeting because they feel singled out.  Should we be worried about them suing the hospital if the policy is put in place?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY JOHN WIECZOREK:
The current legal status of these types of “late career practitioner policies” is in flux.  Late career practitioner policies which screen older physicians at reappointment have been around for decades.  There are published articles detailing the various methods for implementing a late career practitioner policy and how effective those policies were. The rationale for the policies makes sense – catch any potential problems proactively before any patient harm or clinical trends appear.

However, in early 2020 the Equal Employment Opportunity Commission (“EEOC”) filed a lawsuit against Yale New Haven Hospital based on its late career practitioner policy.  The EEOC alleged that Yale New Haven was violating both the Age Discrimination in Employment Act (“ADEA”) and Americans with Disabilities Act (“ADA”) by singling out physicians solely on the basis of their age.  While Yale New Haven is fighting the still-pending lawsuit, certain other hospitals and health systems have withdrawn their policies and paid damages to older physicians after being targeted by the EEOC.

Therefore, creating a new late career practitioner policy or continued enforcement of an old policy creates some legal risk, at least while the EEOC lawsuit against Yale is still pending.  Ultimately, the decision to move forward with such a policy needs to be deliberate, with buy-in from both the hospital’s medical staff and administration, and the knowledge that an adverse court opinion in the EEOC lawsuit will immediately put the brakes on such a policy.

For follow-up questions, please contact John Wieczorek at jwieczorek@hortyspringer.com.

March 10, 2022

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

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

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

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

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

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

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.