June 11, 2020

QUESTION: In response to COVID-19, we recently relocated a hospital provider-based department to a patient’s home.  What information do we need to provide to the CMS Regional Office?

ANSWER: For the duration of the COVID-19 public health emergency, CMS has expanded its extraordinary circumstances relocation exception policy.  According to its April 30, 2020 Final Interim Rule, CMS will permit hospitals to relocate excepted off-campus and on-campus provider-based departments (“PBD”) to off-campus locations.  This includes the ability to expand or relocate a department into a patient’s home.

A hospital that relocates its PBD off-campus must submit a relocation request by email to its CMS Regional Office providing notice and details of its relocation efforts. Specifically, the hospital’s request should include the following information:

  1. The hospital’s CMS Certification Number (“CCN”)
  1. The address of the current PBD
  1. The address of the relocated PBD
  1. The date on which the hospital began furnishing services at the new PBD
  1. A brief justification for the relocation and the role of the relocation in the hospital’s response to COVID-19
  1. An attestation that the relocation is not inconsistent with their state’s emergency preparedness/pandemic plan

Note that a hospital’s justification for relocation should explain why the new PBD location is an appropriate location to furnish outpatient services. In an effort to preserve patient confidentiality, however, the hospital should refrain from referencing patient names of diagnoses in its submissions.

A hospital that relocates a PBD to an off-campus location, such as a patient’s home, will have 120 days from the date on which they began furnishing and billing for services at the relocated site to submit notification to CMS.  In addition, hospitals may include multiple relocation notifications in one e-mail, so long as each submission falls within the 120-day requirement.

June 4, 2020

QUESTION:        What’s the difference between closing a department and an exclusive contract?  Are they both still legally valid?

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ANSWER:          They may have a similar impact but differ in important respects. Both approaches have been generally accepted by the courts, so long as the process by which they are adopted by a hospital board is carried out carefully.  They have in common the concept that a candidate seeking an application for privileges would be advised up front that no applications will be processed except as consistent with the contract(s) or Board-adopted Medical Staff Strategic Plan (MSSP).   (It’s a good idea to develop a form letter to use in communications with those who inquire.)

Many hospitals have exclusive contracts pursuant to which one group is accountable for the quality of professional services and the smooth operation of hospital-based services.  Traditionally these contracts have involved anesthesia, emergency medicine, imaging and pathology/laboratory.  The contracts typically incorporate performance standards.  Increasingly such contracts (which may be semi-exclusive, with several groups as opposed to a single group) encompass other services such as neonatology, interventional cardiology, hospital medicine and others.

Sometimes referred to as a Plan to “close” department as a shorthand, a MSSP has typically not involved contracts but rather a board resolution and policy. A board committee reviews the community needs assessment and other data to determine how to manage medical staff growth, to promote hospital goals.  Numbers of specialists needed, based on formulas, were often identified and reviewed periodically.  That approach has morphed in more recent years to encompass considerations such as financial conflicts of interest such as investments in competing facilities.  One variation more common today is a board decision to operate a service solely through its employed physicians, or through physicians employed by an affiliated group.

Courts have generally upheld both exclusivity in contracts and MSSPs where it is clear that the process was undertaken by the Board, based on proper, documented hospital objectives, with no appearance of undue influence by any physicians who would stand to gain from reduced competition.  Indeed, there has been relatively little litigation in recent years.  MSSPs were historically adopted in an era where very few physicians were employed.  Perhaps the fact that so many physicians are now employed has led to the decline in challenges to both MSSPs and exclusive contracts.  That said, it is important for the Board to assess options and make reasonable determinations based on the hospital’s mission.  Physician input can be obtained, but avoid votes by departments or committees that could be characterized as collective action to restrain trade.  Such allegations are rare now but it remains important to follow a process to demonstrate reasonableness.  Court approval should not simply be assumed!

May 28, 2020

QUESTION:        We have a physician who is up for reappointment and when we started to pull the credentialing, peer review, and quality information together we realized there were very serious concerns that might warrant an adverse recommendation.  We were wondering, do we have to start a formal investigation or, if warranted, can we just make an adverse recommendation at reappointment?  Are there any steps we should follow to make sure we are being fair to the physician and protecting ourselves at the same time?

 

ANSWER:           Reappointment should be an opportunity to make an evidence-based decision that reflects data that has been gathered during the most recent appointment period.  (You can certainly look back further if you need to gain perspective or discern if there are patterns of care or conduct that have been developing.)  Ideally, you will address issues as they come up through the peer review process.  But sometimes, even with a robust peer review process, you don’t see the whole picture until reappointment.

Certainly, if, in looking at relevant information at reappointment, you are concerned enough to consider an adverse recommendation because a lesser action will not be sufficient to protect patients, you have the authority to make that recommendation.  To answer your specific question, there is generally no reason why you would have to commence a formal investigation, separate and apart from the reappointment process.  While many bylaws require that the Medical Executive Committee commence an investigation before making an adverse recommendation, that step would not be required if you are already in the midst of the reappointment evaluation.

In most organizations, the Credentials Committee would do the heavy lifting at reappointment.  That means the Credentials Committee would evaluate the information including documents from the peer review process, incident reports, letters, minutes, and reports.  The Credentials Committee can also rely on the clinical expertise of the department chairperson at reappointment.

As a matter of fairness and good practice, even if your bylaws (or credentials policy) don’t require it, we strongly recommend that the Credentials Committee meet with the physician before it makes an adverse recommendation.  The physician should be given advance notice of the concerns and at the meeting (or in advance of it) the physician should have an opportunity to respond to the concerns.  It will be very helpful to keep a detailed summary of this meeting, including the physician’s response.  The minutes should also reflect, in some detail, the reasons for the adverse recommendation – you’ll need that when you get to the hearing.

One issue that sometimes comes up in difficult reappointment matters is timing.  If the physician’s current appointment is set to expire, you may need to grant a short-term conditional reappointment to give you time to conduct the evaluation and assessment, meet with the physician, and prepare a report of concerns to support an adverse recommendation.  The report and recommendation of the Credentials Committee will need to be forwarded to, and acted on, by the Medical Executive Committee.  If the Medical Executive Committee upholds the adverse recommendation that will trigger the physician’s right to a hearing.

Remember, the hearing and appeal processes are going to take months to complete.  The Credentials Committee and Medical Executive Committee should consider whether there are any conditions that need to be put in place while the processes are being carried out to keep patients safe in the interim.

May 21, 2020

QUESTION:         We used emergency, alternative credentialing methods to grant privileges to additional practitioners at the outset of the COVID-19 pandemic — and to grant additional privileges to practitioners who were already members of our Medical Staff but willing to work beyond their normal scope of practice in order to help us best respond to community needs.  Now, as we are winding down some alternative care sites and trying to find ways to get elective surgeries and treatments back on track, we are facing new dilemmas.  For example, we need to offer some elective procedures at alternative care sites because certain facilities in the health care system are still dedicated to COVID care.  If we want to have a practitioner from hospital A exercise his or her privileges in hospital B or an affiliated ambulatory surgery center, do they have to apply for Medical Staff appointment and privileges?  We’ll never get that done on time.  Can we continue to rely on temporary privileges and disaster privileges to get those individuals privileged and “up and running” at the other sites — even though they are not treating COVID patients (on the basis that the shifting of sites is nevertheless related to the COVID-19 pandemic)?

ANSWER:            Just because the initial crisis is passing does not mean that the COVID-19 emergency is over — nor that the solutions for dealing with the emergency are unavailable to credentialers.  You should, of course, check the Medical Staff Bylaws and/or Credentials Policy of the organization where an individual is to be privileged to determine what they say about temporary privileges for an important patient care need and/or disaster privileges.  But, in all likelihood, both of these options will be available to you to help you solve the conundrum about how to temporarily get elective (but still necessary) procedures back on the schedule and underway, to meet the needs of your community.  It’s important to remember, in the case of disaster privileges, that they can continue to be granted for so long as the emergency management plan is activated (which, in the case of most hospitals dealing with COVID-19, will probably be for quite some time).  Of course, disaster privileging has its limitations (including that the institution that grants them is supposed to implement some method for monitoring those who have been granted disaster privileges and then periodically reviewing — perhaps every 72-hours for Joint Commission accredited hospitals — whether they should be continued).  In this scenario, temporary privileges may provide a better option, since they can generally be granted for a longer time period initially (up to 120 days, pursuant to most Medical Staff Bylaws and related documents) and can be granted again and again if need be.

Of course, if the practice arrangement goes from a short-term arrangement to a long-term arrangement, then it would make sense to start full credentialing of the practitioners who have now been privileged to provide services at the alternative site.  But, many organizations may find that as the COVID-19 pandemic passes, most practitioners are happy to get back to their usual places of practice and, in turn, full credentialing at the alternative site may not end up being necessary.

May 14, 2020

QUESTION:  We run an acute care hospital.  In order to prevent the spread of COVID-19, we have allowed some of our practitioners to provide services to Medicare beneficiaries via telehealth.  These Medicare beneficiaries are receiving services in their homes that they would normally receive in the hospital’s outpatient department.  What does the recent interim final rule from CMS say about the practitioner’s ability to bill for this sort of arrangement?

 

ANSWER:  Effective March 1, 2020, when a practitioner who ordinarily practices in a hospital outpatient department furnishes a telehealth service to a patient who is located at home, they may submit a professional claim with the place of service code indicating that the service was furnished in the hospital’s outpatient department.  Medicare will then pay the practitioner under the Physician Fee Schedule at the facility rate (as though the service had been provided in the hospital’s outpatient department).

The interim final rule contains further details about the hospital’s ability to bill for its services.  To access the interim final rule, click here.  For a general overview of recent Medicare telehealth developments, click here.

May 7, 2020

QUESTION:          In an effort to manage exposure during the COVID-19 pandemic, we are trying to expand the use of telehealth throughout our system.  Do we need to grant “telemedicine privileges” to Medical Staff members who have already been credentialed and privileged before the pandemic started if they are now using telehealth to treat patients remotely? We are Joint Commission accredited. 

 

ANSWER:           This question seems to be coming up a lot.  Fortunately, The Joint Commission has given out some good guidance on how to handle this issue during the COVID crisis.  In an FAQ document, The Joint Commission has advised:

“Licensed Independent Practitioners (LIP) CURRENTLY credentialed and privileged by the organization, who would now provide the same services via a telehealth link to patients, would not require any additional credentialing or privileging. The medical staff determines which services would be appropriate to be delivered via a telehealth link. There is no requirement that ‘telehealth’ be delineated as a separate privilege.” (Emphasis added.)

This Standards FAQ can be found here.


In light of this guidance, there does not appear to be a need to grant telemedicine privileges to physicians or other practitioners who have already been granted clinical privileges simply because they are now delivering services via telehealth.  In light of the statement that the “medical staff determines which services would be appropriate to be delivered via a telehealth link,” it may be prudent to have your MEC weigh in on what services can be provided in this fashion.

April 30, 2020

QUESTION:        Our hospital is eligible to receive money from the CARES Act Provider Relief Fund. The HHS Terms and Conditions say that the payment will only be used to prevent, prepare for, and respond to coronavirus, and shall reimburse the Recipient only for health care related expenses or lost revenues that are attributable to coronavirus.  There is also a condition that none of the funds can be used to pay individual salaries “in excess of Executive Level II.”  Can we still use the money to offset losses that our hospital and physician practices incurred resulting from the cancellation of elective procedures due to the lockdown order in our state?

 

ANSWER:            Yes, as long as the funds are not used to subsidize any particular physician’s salary. The Terms and Conditions incorporate by reference HRSA guidance about the salary cap, which was part of the original Congressional grant appropriation. Effective January 2020, the “Executive Level II” salary level is $197,300.  According to HRSA: “An individual’s institutional base salary is not constrained by the legislative provision for a limitation of salary. The rate limitation simply limits the amount that may be awarded and charged to HRSA awards. For individuals whose salary rates are in excess of Executive Level II, the non-federal entity may pay the excess from non-federal funds.”  So as long as the money is not used to fund any particular individual’s salary, you should be able to use the money to offset general losses experienced by your hospital or physician practices without the salary cap affecting what you pay.

April 23, 2020

QUESTION:          Any tips for virtual board meetings?

 

ANSWER:            My wife, Pauline, was sworn in as mayor of our municipality in January.  There was a council meeting in February, but the meeting in March was cancelled due to COVID-19.  However, the municipality’s business still had to be conducted, so the April meeting had to be held, and it was conducted as a “virtual” meeting.

The first tip is to have two or three “dry runs” to work out any glitches.  During the dry runs, some council members were having trouble getting into the meeting, or would get into the meeting but couldn’t be heard, or couldn’t be seen.  Those problems were all solved.  So, work with the IT department to identify and solve issues.

Another tip is to realize that the normal procedure may have to be altered for practical reasons.  Usually at council meetings, the public is permitted to speak after each agenda item is on the floor.  So, in a normal meeting, if there are five agenda items, a resident may get up to speak five times.  However, because that would have been technically difficult, burdensome and not very practical in a virtual meeting, the procedure was changed so that a resident could speak regarding any or all of the agenda items all at once.

An additional tip is to start the board meeting with a “confidentiality reminder.”  These aren’t necessary at council meetings since our municipality has to adhere to the state “sunshine” act which means that the meetings are open to the public, except for some very specific issues, such as personnel matters.  So, start the meeting with a reminder and document it in the minutes.  The reminder could include practical matters, such as stating the board members should try to avoid being in a place in the house where the members can be overheard, or the audio from the meeting can be heard.  Also, a reminder to not download emails with peer review, Protected Health Information, or confidential attachments to their home computers which everyone in the house has access to.

Finally, when COVID-19 has hopefully passed, take everything that has been learned to develop a policy on virtual meetings.  Hopefully, it will never have to be used again, but you will be ready for the next big snowstorm!

April 16, 2020

QUESTION:        We expect to have a surge of coronavirus patients in the next week or two, so we are currently credentialing and privileging practitioners to help with the patient volume.  Should we rely exclusively on disaster privileges for this, or should we consider temporary privileges instead?  What about emergency privileges?

 

ANSWER:          Emergency privileges are not an ideal tool for dealing with a pandemic.  Emergency privileges are intended for scenarios where a patient experiences a sudden emergency and a physician rushes to help.  For example, imagine a circumstance where a (seemingly healthy) patient is visiting your hospital and collapses suddenly.  Emergency privileges would authorize a physician to provide emergency care at the scene that goes beyond the scope of his or her clinical privileges.  That authorization would last only until the emergency was under control.

Consequently, the main question is whether you should grant temporary privileges (for an important patient care need) or disaster privileges.  If you have a week or two to prepare for a surge in patient volume, then it may be optimal to consider temporary privileges.  If you are part of a system (even if there is not a unified medical staff) you could pass a resolution allowing for the grant of temporary privileges for an important patient care need to any physician, or other practitioner, who has been fully credentialed by any hospital within the system.  The only verification that would be necessary would be confirmation from the medical staff office or credentialing verification office that the individual maintains appointment and clinical privileges within the system.  Additionally, as with any other grant of clinical privileges, you would have to query the NPDB.  This query should be made before the physician starts to work.

Disaster privileges can be used if you need to onboard someone very quickly.  Generally speaking, disaster privileges can be granted after you verify a volunteer’s identity and licensure.  Accreditation standards place certain timelines on the verification of licensure.  Note that the Joint Commission also requires an oversight process for volunteers who are licensed independent practitioners and who have been granted disaster privileges.  Specifically, based on the oversight, the hospital must determine within 72 hours if disaster privileges should continue.  A similar process must be followed for volunteers who are not licensed independent practitioners but who are “required by law and regulation to have a license, certification, or registration” (e.g., respiratory therapists).

This is a rapidly evolving topic, and it is important to consider your own unique needs and circumstances when evaluating these options.

April 9, 2020

QUESTION:         Physicians have been offering to provide services outside their specialty to assist with our hospital’s COVID-19 response.  However, they’re concerned that their malpractice insurance may be limited to care provided within their specialties.  Are there any other legal protections available to them?

 

ANSWER:            Yes.  There are several federal laws that would protect physicians from malpractice liability for services provided to COVID-19 patients.  The best protection is for those who volunteer their services (i.e., do not bill or otherwise receive compensation).  State law should also be reviewed, as many states have similar protections.

None of the following statutes can prevent a lawsuit from being filed, and none provide absolute protection to health care professionals.  However, they should provide reassurance to professionals who provide services that might fall outside the limits of their insurance policies.

  1. CARES ACT

The federal Coronavirus Aid, Relief and Economic Security Act (CARES Act) was passed on March 27, 2020 to address the COVID-19 pandemic.  Section 3215 of the CARES Act states broadly that:

a health care professional shall not be liable under Federal or State law for any harm caused by an act or omission of the professional in the provision of health care services during the public health emergency with respect to COVID–19 declared by the Secretary of Health and Human Services…

Importantly, the CARES Act applies only to “volunteers,” which means the Act does not apply to professionals who bill third party payors for their services or who receive any other compensation.  The only exception is that mileage and lodging can be provided to those who travel more than 75 miles to volunteer their services.

The CARES Act applies to professionals who provide “health care services,” which is defined broadly to include “the diagnosis, prevention, or treatment of COVID-19” or “the assessment or care of the health of a human being related to an actual or suspected case of COVID-19.”  Thus, any action taken by a volunteer with respect to a suspected or actual COVID-19 patient should be covered.  However, the CARES Act wouldn’t apply to physicians who volunteer to treat non-COVID patients to relieve the burden on those treating COVID patients.

The CARES Act also requires health care professionals to be providing services “within the scope of the license, registration, or certification of the volunteer.”  This will not pose a problem for physician volunteers, but non-physician volunteers should be careful not to exceed their licenses.

Not surprisingly, the CARES Act does not apply to willful or criminal misconduct.  Most of the laws described below have a similar limitation.

  1. PREP ACT

The federal Public Readiness and Emergency Preparedness Act (PREP Act) differs from the CARES Act in that the PREP Act is not limited to volunteers.  Health care professionals who are paid for, or bill for, their services are still covered by the PREP Act.

However, the PREP Act probably applies to a narrower set of actions by health care professionals.  The PREP Act provides legal protection to persons and entities that manufacture, distribute, administer, prescribe or use “Covered Countermeasures.”  A Covered Countermeasure is a drug, device or biological product used to treat COVID-19.  It is not clear if the PREP Act would apply to allegations that a physician failed to diagnose COVID-19 or took some other action that did not involve a drug, device or biological product.

  1. VOLUNTEER PROTECTION ACT

The federal Volunteer Protection Act (“VPA”) provides that a volunteer to a nonprofit organization cannot be held liable for harm caused by any act or omission so long as the volunteer was acting without compensation and within the scope of the volunteer’s responsibilities.

To be covered under the VPA, an individual must be a “volunteer” – which means that he or she must be volunteering for a nonprofit organization and cannot receive compensation, or anything else of value, in excess of $500 per year.