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).

March 19, 2020

QUESTION:          As we ramp up our response to COVID-19, we are concerned that we may not be able to process routine applications for reappointment in a timely fashion.  Do we have any leeway?

ANSWER:            The Joint Commission recently published an FAQ on this issue.   According to the FAQ, if an established member’s clinical privileges are going to expire during the national emergency, The Joint Commission will allow an automatic extension so long as the following conditions are met.

First, a national emergency must have officially been declared.  As we know, this happened by proclamation dated March 13, 2020.  Second, your organization must have activated its emergency management plan.  This activation should be documented.

Finally, state law must not prohibit extending the duration of privileges during an emergency.  Most states are issuing broad emergency orders allowing for flexibility in the health care arena to respond to COVID-19.  We do not expect this last factor to serve as a prohibition.

According to The Joint Commission, the duration of the extension cannot exceed 60 days after the state of emergency has ended and the organization should “determine[] how the extension will be documented.”  We have included a sample resolution below that addresses both extending the term of reappointment and the grant of disaster privileges.

BOARD RESOLUTION

PRACTITIONER CREDENTIALING DURING THE COURSE

OF THE COVID-19 NATIONAL EMERGENCY

WHEREAS, the COVID-19 national emergency has caused widespread closure and/or personnel strain at health care facilities, universities, and government agencies, and has resulted in the cancellation of many activities underlying practitioner credentialing (e.g. board certification examinations, basic life support, and other certifications) and disruption of the Hospital’s ability to obtain primary source verification of certain practitioner credentials during the course of processing applications for initial appointment to the Medical Staff and Advanced Practice Clinician Staff (“appointment”), for the grant of clinical privileges, and for the processing of applications for reappointment to the Medical Staff and Advanced Practice Clinician Staff (“reappointment”);

WHEREAS, the COVID-19 national emergency may create a need for the Hospital to grant clinical privileges to practitioners whose credentials are not in accordance with those required in non-emergency periods, as outlined in the Medical Staff Bylaws, Medical Staff Credentials Policy, and related policies, procedures, and privilege delineation forms;

NOW, THEREFORE, BE IT RESOLVED THAT the Board has determined that immediate, temporary credentialing methods are necessary to ensure that the Hospital can continue to meet the needs of the community during the course of the COVID-19 national emergency.  As such, the credentialing methods set forth in this resolution are hereby authorized for individuals seeking appointment, reappointment, and clinical privileges, for the duration of the COVID-19 national emergency and for the immediate time period thereafter up to 60-days following the conclusion of the COVID-19 national and/or local emergency declarations)

BE IT FURTHER RESOLVED THAT during the course of the COVID-19 national emergency, the procedures for disaster privileging may be followed to grant clinical privileges to those specifically responding to the COVID-19 national emergency, as well as to applicants for initial appointment or initial clinical privileges, or applications for additional privileges from practitioners already practicing at the Hospital, insomuch as the credentialing of such individuals is disrupted by the COVID-19 national emergency.

BE IT FURTHER RESOLVED THAT during the course of the COVID-19 national emergency, the Chief of Staff is authorized to extend the reappointment and clinical privileges of any practitioner who is currently appointed with privileges at the Hospital as of March 13, 2020 (the date the COVID-19 national emergency was declared).  Unless otherwise determined by the Chief Executive Officer, the extension of reappointment and clinical privileges will last until 60-days following the conclusion of the COVID-19 national emergency or until such time as the individual’s application for reappointment and renewal of clinical privileges can be processed, whichever occurs sooner.

ADOPTED by the Board, March _____ 2020.

                                                                              

Chairman, on behalf of the Board of Trustees

For more information on privileging during a national emergency or disaster, click here or here.

March 12, 2020

QUESTION:        We had an applicant who “forgot” to disclose two hospitals where she practiced in the past when she completed her application form.  We found out about one of them through a National Practitioner Data Bank query and the other when we directed her to correct her application form.  She was very apologetic and said it was an accident because her office manager completed the form.  What do we do with this now that we feel like she wasn’t honest? It seems unlikely that she “forgot” an affiliation where they restricted her privileges.

ANSWER:          Misstatements and omissions on application forms can certainly be very serious and the concerns that your medical staff leaders have are justified. The act of completing a medical staff application form is a practitioner’s very first administrative contact with the hospital.  As an administrative function, we recommend having an administrative response when this type of discrepancy is discovered.  That response should not be an invitation to “correct” the application form, because through the use of such language, it implies to the practitioner that there are no concerns raised by their initial completion of the form or that those concerns are fully resolved by their “correcting” the erroneous information.

Rather, we recommend having medical staff bylaws/credentials policy language that clearly states that the hospital will stop processing an application if a misstatement or omission is discovered – and if it is not discovered until after appointment has been granted, that appointment will be automatically relinquished.  The applicant should be notified of the misstatement or omission and given an opportunity to respond, and then there should be an administrative-level review of that response to determine whether or not to move forward.  The same language should be on the application form release that the individual signs upon completing the application form.  Addressing this issue on an administrative level means avoiding words like “rejection” or “termination” of the application or “denying” the application – which is an action that is only ever taken following a comprehensive review of the application and all supporting materials in its entirety.

March 5, 2020

QUESTION:      I heard that Congress is considering legislation that would support nationwide responses to the risk of coronavirus.  What’s the status of that legislation?

ANSWER:        Yes, Congress is currently considering the Coronavirus Preparedness and Response Supplemental Appropriations Act.  It has passed the House and is now under consideration in the Senate.  Among other things, the proposed bill provides additional funding to the CDC, FDA, and NIH, and also provides funds for the development of vaccines, therapeutics, and diagnostics.  It directs the Secretary of Health and Human Services to purchase vaccines (when they become available).

It is likely that this draft will be revised significantly before it becomes law.  If you would like to track its progress, you can do so here.

UPDATE:         The bill has passed the Senate and it now goes to President Donald Trump for his signature.

February 27, 2020

QUESTION:       What is the federal government doing regarding the Coronavirus (COVID-19)?

ANSWER:          The Centers for Disease Control and Prevention (“CDC”), of course, has taken the lead and is constantly updating the public on the situation.  Yesterday, the CDC confirmed an infection in California in someone who did not have travel history or exposure to someone else with COVID-19.  The CDC stated, “At this time, the patient’s exposure is unknown.  It’s possible this could be an instance of community spread of COVID-19, which would be the first time this has happened in the United States.  Community spread means spread of an illness for which the source of infection is unknown.  It’s also possible, however, that the patient may have been exposed to a returned traveler who was infected.”

The CDC went on to state, “This case was detected through the U.S. public health system — picked up by astute clinicians.  This brings the total number of COVID-19 cases in the United States to 15.”

PLEASE NOTE: The CDC has a dedicated Coronavirus internet site where it discusses “What You Should Know,” “Situation Updates” and “Information For…HealthCare Professionals.”

February 20, 2020

QUESTION:        We’re thinking of a joint venture with a company who we don’t know that well.  What should we watch out for?

ANSWER:           Any time you are thinking of a joint venture with anyone who you have not dealt with before, you should do your homework and conduct due diligence in much the same way you would in a merger, although not quite as intense.  Among other things, make sure you know who all the owners of your potential joint venture partner are.  Run a background check on them and also check the OIG exclusion list to see if they are on it.  Check with others who have done business with them before.  And make sure they have the financial wherewithal to bear their share of start-up costs.

These are only a few questions.  There are a lot of other things you should look into from a tax, antitrust and fraud and abuse perspective.

For more on what you should look for when considering a joint venture, check out Horty Springer’s recent podcast “Thinking of a Joint Venture?  Look Before You Leap!” by  Dan Mulholland  and  Henry Casale at our Health Law Expressions page; or even better, join Henry and Dan in Chicago on April 23 – 25 for the Physician-Hospital Contracts Clinic where they will discuss this and other hot compliance topics in detail.

February 13, 2020

QUESTION:            We are revising our Medical Staff Bylaws and a question has come up about whether we could add a “years of service” exemption that let’s physicians opt-out of their ED call obligations if they have been on the Medical Staff for more than 20 years. Is this okay under EMTALA?

ANSWER:            It is. CMS recognized the practice of giving age or year’s of service based exemptions in the 2003 Preamble to the updated EMTALA Regulations, stating:

“We understand that some hospitals exempt senior medical staff physicians from being on call. This exemption is typically written into the hospital’s medical staff bylaws or the hospital’s rules and regulations, and recognizes a physician’s active years of service (for example, 20 or more years) or age (for example, 60 years of age or older), or a combination of both. We wish to clarify that providing such exemptions to members of hospitals’ medical staff does not necessarily violate EMTALA. On the contrary, we believe that a hospital is responsible for maintaining an on-call list in a manner that best meets the needs of its patients as long as the exemption does not affect patient care adversely. Thus, CMS allows hospitals flexibility in the utilization of their emergency personnel.” (Emphasis added).

Obviously, the highlighted language indicates that while such exemptions are permissible under EMTALA, the exemptions cannot interfere with a hospital’s ability to maintain adequate on-call services.

Therefore, we recommend the MEC approve any request for such an exemption, since allowing an exemption to take effect automatically could create EMTALA problems, depending on the number of remaining physicians in the specialty.  Furthermore, we also recommend including language that states the MEC can require a physician who was previously given an exemption to return to the call schedule (on a temporary or permanent basis) if the needs of the Hospital change.

February 6, 2020

* * *
QUESTION:      What do you recommend for the composition of the Credentials Committee and the terms for service for the members?
* * *

ANSWER:         A Credentials Committee is best composed of experienced leaders, such as past chiefs of staff or other physicians who have had medical staff leadership experience.  Many Medical Staffs have representation from a variety of specialties to ensure that the committee has the expertise necessary to address difficult credentialing and privileging issues.  With the increasing number of advanced practice clinicians (e.g., nurse practitioners and physician assistants) providing services in hospitals, more and more Medical Staffs are appointing at least one advanced practice clinician to the Credentials Committee as a voting member and for that individual’s input and expertise on the topic of credentialing and privileging these providers.

Service on the Credentials Committee should be the primary medical staff obligation of the members and terms should be at least three years so that committee members have an opportunity to gain some experience and expertise in credentialing.  The terms should also be staggered so that there is always a repository of expertise on the committee.  This Credentials Committee’s primary responsibility is to review and make recommendations on applications for medical staff appointment and clinical privileges.  It can also oversee the development of threshold eligibility criteria for clinical privileges.

January 30, 2020

QUESTION:        I heard that the Department of Health and Human Services released a new rule on partial fills of opioid prescriptions.  Can you give me a brief overview of the change?

ANSWER:          Yes.  The Department of Health and Human Services (“HHS”) has issued a final rule designed to improve tracking of transactions involving Schedule II drugs.  Briefly stated, this change requires certain covered entities to report “quantity prescribed” data for transactions involving Schedule II drugs.  The data will track whether the prescription was partially filled (which is legal under some circumstances) or refilled (which can potentially be a violation of the Controlled Substances Act).

If your organization is covered by HIPAA and has a retail pharmacy that dispenses Schedule II drugs, you should check to see whether this law may have an impact on your workflows and recordkeeping.  The final rule is available here.