November 5, 2020

QUESTION:        I know that the Centers for Medicare and Medicaid Services (“CMS”) have made certain regulatory flexibilities available in response to the public health emergency.  Where is the best place to learn more about these changes?

 

ANSWER:           CMS has made available a large amount of material relating to COVID-19 on its website, but it isn’t always easy to find a specific piece of information (or to know when something’s been recently updated).  Speaking generally, the best starting point for research is the agency’s “Current Emergencies” page, which you can find here.  It’s a bit overwhelming at first, but I would first suggest that you focus on the link that says:  “Get waiver & flexibility information.”  This will take you to a new page that lists “Waivers & flexibilities for health care providers.”  You can skim that list to look for items that may be relevant to your question.  I often scroll down to the “provider-specific fact sheets” when I am beginning my research.

Be careful of relying too heavily on any one document, unless it is crystal clear.  These guidance pages are being updated regularly, and we have encountered numerous situations where the information provided can be misleading or seriously incomplete.  Although it’s not always possible, it’s good if you can locate relevant material from a regulation.

If you have a question about a recent change to a policy, be aware that the agency may not yet have an answer for you.  Under these circumstances, it may be helpful to check this list of CMS podcast transcripts to look for recent updates.  The “CMS Office Hours” calls will often have transcripts that you can search.  (If you have the time, you can also call into one of the agency’s “Office Hours” calls directly.  Agency representatives make themselves available to answer questions related to the Medicare program.)

These online resources can be a helpful way to answer run-of-the-mill questions, but we would encourage you not to rely on them for more important matters.  In those cases, it’s best to seek legal counsel.

September 10, 2020

QUESTION:        I heard that the Centers for Medicare & Medicaid Services (“CMS”) recently announced a new payment model, referred to as the “Community Health Access and Rural Transformation (“CHART”) Model.”  Can you provide a brief overview of this?  Is participation mandatory or voluntary?

 

ANSWER:          CHART is a voluntary payment model intended to improve health care quality in participating rural communities.  Participating rural communities have the option to choose between one of two different “tracks.”  The first is labeled the Community Transformation Track, which builds upon certain lessons learned from the Maryland Total Cost of Care Model and the Pennsylvania Rural Health Model.  To participate, communities must identify a Lead Organization (such as a local public health department or health system).  In exchange for spearheading efforts to implement health care redesign in the targeted community, the Lead Organization is eligible to receive up to $5 million in funding.  This track is scheduled to begin in July of 2021.

The second is the ACO Transformation Track.  This enables rural accountable care organizations (“ACOs”) to receive advance shared savings payments.  CMS hopes that these advance payments will encourage rural ACOs to advance more quickly into models that involve downside risk (i.e., two-sided risk models).  This track is scheduled to begin in January of 2022.

It is important to keep in mind that the CMS Innovation Center is designed to test and experiment with various payment and service delivery models, which means that its initiatives often involve significant risk and uncertainty.  CHART is no different.  Although the agency hopes that this will result in improved health care quality at reduced cost, there are key obstacles that the agency (and the participants) will need to overcome.  For example, what sorts of entities are well-qualified to serve as a community’s Lead Organization (responsible for developing a strategy to redesign the community’s health care delivery system)?  How effective will the participants be in redesigning their health care delivery systems while simultaneously juggling the demands of the COVID-19 pandemic?  Assuming that rural ACOs do choose to accept downside risk, how resilient will they be if obstacles or mistakes cause them to fall short of their goals?

If participants are able to navigate through and ultimately overcome these obstacles, it will be a promising sign for the future of large-scale efforts to promote value-based payment systems nationwide.

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.

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 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 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.

 

April 2, 2020

QUESTION:        Where can we find any and all updates regarding the coronavirus?

 

ANSWER:          We have those resources on our “What’s New in Health Law Coronavirus (COVID-19) Resources” page at hortyspringer.com. It is a comprehensive collection of links that will keep you updated on COVID-19.  So please check the page often to get the latest.

For example, check out this simple but brilliant innovation by our friends at Armstrong County Memorial Hospital. This newly designed DIY intubation shield allows for an extra barrier of protection for healthcare providers during the COVID-19 pandemic.

March 26, 2020

QUESTION:        We are a six-hospital system and are doing our best to address and anticipate the health care needs of patients with COVID-19.  Two of our hospitals are Critical Access Hospitals, which is why our medical staffs are not unified.  Nonetheless, we have a system CVO and our bylaws, credentials policy and privileging criteria are consistent.  If we want to be flexible about deploying needed practitioners to our various hospitals by using temporary privileges for those practitioners who do not hold privileges at each hospital, must we get new peer references from their primary system hospital? What are our other options for granting privileges for these practitioners at hospitals in our system where they are needed?

 

ANSWER:        Technically, each hospital with a separate CCN and license is supposed to get a peer reference to confirm current competence, under both Joint Commission and DNV GL NIAHO standards, without reference to whether a hospital is part of a system.  However, under these difficult circumstances, of course it makes sense to take advantage of the system’s knowledge of privileging at other system hospitals to speed up the availability of practitioners to go where they are needed most.  Here are some options:

  • For those who are somewhat risk averse and have the time and resources, the system CVO (or centralized Medical Staff Office) could pre-populate a short “application” form so there would be little the “applicant” would need to do other than sign electronically. That form could refer to a standard department chief/chair peer reference communication to be used within the system, which confirms current competence based on OPPE (or FPPE if applicable for recently appointed practitioners) or the last reappointment recommendation/report.  However, those under a performance improvement plan or investigation would not be eligible except on a case-by-case basis.
  • Pursuant to a system information sharing policy, Board resolution, or agreement, the standard department chief/chair peer references could be accessed electronically throughout the system or the actual recent OPPE or reappointment reports could simply be made available directly without the need for the separate peer reference form.
  • A system could simply let the practitioners go where they are needed, via a Board and MEC resolution, and justify it later if surveyors question it. Will surveyors really cite hospitals for having moved quickly to get known practitioners to respond to the community?  We doubt it.
  • A few systems have created a category on each medical staff in the bylaws for all physicians who are appointed to other hospitals’ staffs. The CVO has all the information.  The physicians in that category are permitted to exercise privileges at all system hospitals where the services they provide are offered, even though they designate a primary hospital.  (One reason that systems do this is to create a panel of peer reviewers to review cases at other system hospitals when there is a potential conflict, or to use those physicians as locum tenens in system hospitals to avoid contracting with locum tenens firms and thereby getting unknown physicians.)
  • Another option is for each hospital to grant disaster privileges quickly and as needed, in reliance on the CVO’s files containing licensure, and verify identity when they report for duty.

Join Charlie Chulack and Barbara Blackmond for the next installment in our Grand Rounds audio conference series on April 7 on Making the Most of your Relationship with Credentials Verification Organizations (CVOs).