Author: hortyspringer

November 5, 2020

Posted on by hortyspringer

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.

October 29, 2020

Posted on by hortyspringer

QUESTION:        I heard on a recent audio conference that nurse practitioners are not permitted to be listed on the emergency department call schedule.  But, it’s commonplace at our Hospital for the hospitalists to split call amongst the doctors and the nurse practitioners.  It’s been this way for years.  Did something change?

 

ANSWER:          The Emergency Medical Treatment and Active Labor Act (“EMTALA”) has always required that a physician be listed on the on-call roster for the emergency department (“ED”). Nurse practitioners, physician assistants, and other non-physicians do not suffice to satisfy this legal requirement.

That does not necessarily mean your hospital has been doing things wrong, however.  When the term “on call” is thrown around by those involved in hospital and medical staff compliance matters, sometimes things get jumbled up a bit – because that term can mean a number of things.

It is perfectly acceptable for nurse practitioners, physician assistants, and other non-physicians to be on call for their private group practice or for their employer (for example, physician assistants who are part of an employed or contracted hospitalist group that covers all patients admitted to the hospital).  These individuals likely are responding to calls about the practice’s patients (sometimes from the ED and sometimes from the floor) and they may even agree to take on some unassigned patients who present to the hospital, if no one else is available to assume those patients’ care.

This is different than the ED’s on-call roster.  The on-call roster is used by the hospital to ensure that services that are designed to meet the needs of the community are available within the ED.  This is the roster of physicians who respond in the event that a patient comes to the ED and is determined to be suffering from an emergency medical condition that requires stabilization.  In some (most) hospitals, if the patient lacks an existing patient-physician relationship with the type of specialist (e.g., cardiology, oral and maxillofacial trauma surgeon) whose services are required, the patient is considered “unassigned” and, by policy, the physician listed on the ED’s on-call roster must respond to the hospital to care for the patient (as requested by the ED physician).  In some hospitals, all patients who come to the ED after normal business hours are assigned to the ED’s on-call physician, though that is less commonly the policy.

To summarize: When an individual is covering their own practice’s patients, that person is not generally considered to be on the ED’s on-call roster.  As long as hospital policy allows it, a practice can choose any of its practitioners to respond to calls to the practice about their own patients.

For the ED roster that is designed with EMTALA compliance in mind, however, a physician must be listed (by name, not by group practice).  It is likely that this is the way your hospital has been managing things, since the requirement for a physician to be listed has not changed.  The confusion generated during the recent audio conference that you listened to probably lies in the ambiguity over the term “on-call roster.”

October 22, 2020

Posted on by hortyspringer

QUESTION:        We have a new crop of Medical Staff leaders taking office on January 1.  How do we get them up to speed with no live seminars this fall?

ANSWER:          Fear not! Horty Springer is bringing its live seminars to a virtual platform, so your new Medical Staff Officers, chairs, and committee members can get all the education they need to become effective physician leaders in the New Year!

These courses will provide the same engaging, practical, and entertaining content that you expect from Horty Springer right to your PC, laptop, or iPad, so please join us this fall!

 

October 15, 2020

Posted on by hortyspringer

QUESTION:        In the Tayefeh v. Kern Medical Center case summarized in this week’s Health Law Express, there was confusion about whether the physician was entitled to a Medical Staff hearing because of his failure to disclose certain unfavorable information and the resulting “termination” of his clinical privileges.  Is there any way that we can make it clear in our Medical Staff Bylaws or Credentials Policy that such an event does not give rise to a hearing?

 

ANSWER:          Yes.  While it is always important to consult requirements under state law, which may address situations when a hearing is required (we saw the California Business and Professions Code come into play in the Tayefeh case), your Medical Staff Bylaws or Credentials Policy (“Bylaws”) should clearly define the consequences for certain events and the circumstances that give rise to a hearing.  In Tayefeh, the physician failed to disclose an “accusation” filed against him by the Medical Board of California.  The Bylaws should spell out the results of failing to disclose information requested on the application and instruct that any misstatement in, or omission from, the application is grounds to stop processing the application. A decision not to process an application for these reasons does not entitle the applicant to a hearing or appeal.

With that in mind, it also makes sense to review your application forms to confirm that the application questions are seeking information that you need to make an informed decision about someone’s qualifications.  For example, the hospital’s application in the Tayefeh case not only sought information on past actions by licensing boards, it also asked for information on pending actions.  Confirm that the questions on the application form are consistent with provisions in the Bylaws with respect to the threshold eligibility criteria that someone must satisfy for eligibility for appointment.  If one of your threshold eligibility criterion requires an applicant to “have a current, unrestricted license to practice that has never been subject to any restrictions, conditions, or probationary terms and have never had a license to practice in any jurisdiction denied, revoked, restricted or suspended by a state licensing agency,” then there should be a corresponding question on the application seeking this information.

Finally, your Bylaws should place an obligation on members to notify the Medical Staff Office of any change in information provided as a part of the application and state that a failure to do so may result in administrative relinquishment of appointment and clinical privileges.  This permits the Medical Staff and Hospital to evaluate any changes in an individual’s qualifications, weigh those changes against eligibility criteria, and assess the appropriateness of any applicable consequences under the Bylaws.  Unless state law requires it, an administrative relinquishment of appointment and clinical privileges because of failure to continuously satisfy threshold eligibility criteria does not give rise to a Medical Staff hearing.

October 8, 2020

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QUESTION:        Our Medical Staff Bylaws require all bylaws amendments to be accomplished at an officially called, in-person meeting.  As a result, we have been compiling revisions for months (years?) because of the logistics involved in getting this done.  The issue has now come to a head because we have revisions that really have to get into our Bylaws in preparation for an upcoming survey.  Do medical staffs really still vote on bylaws amendments in meetings?  No one shows up for meetings any more — even before the complications created by the current pandemic! Is this still a current practice?  Should it be?

 

ANSWER:           In our experience working with medical staffs across the country, the answer has pretty clearly become no.  While it was traditional for big things — like bylaws amendments and voting on medical staff officers — to occur in in-person medical staff meetings, that tradition has been changing significantly over the past decade.  The negative spin on the move away from in-person voting is that people have stopped showing up for meetings — there just isn’t enough time in the day for all of the patient care issues that have to be addressed to then make time for medical staff citizenship obligations.  However, what we hear most often is the positive side of this coin — which is that by moving away from in-person meetings to take action, which, no matter when they are held (early morning, lunchtime, or late afternoon/evening) will exclude some portion of the medical staff, it is a way to get the input of a much more board cross-section of the medical staff.  The reality is that folks have more time to read an email that includes the proposed amendment and a description of the rationale than they to do attend a meeting.

We have also worked with a number of medical staffs that have opted to “open forum” meetings to discuss proposed bylaws amendments (generally when there is a comprehensive revision process underway), but then conduct the actual vote through email or other electronic ballot — again, attempting to reach as many members of the medical staff as possible.

October 1, 2020

Posted on by hortyspringer

QUESTION:        We unintentionally sent an unencrypted email containing Protected Health Information (“PHI”) to the wrong person, who is a business associate.  Is sending an unencrypted email a HIPAA breach?

ANSWER:          No.  The HIPAA Rules that come into play here are the Privacy Rule and the Security Rule.  HIPAA defines “breach” to mean the acquisition, access, use or disclosure of PHI “in a manner not permitted under [the Privacy Rule]….”  So, a “breach” can occur only if the Privacy Rule is violated – Security Rules violations are not “breaches” – and merely sending an unencrypted email containing PHI, without more, does not violate the Privacy Rule (however, sending an unencrypted email could possibly violate the Security Rule, since it has standards that discuss encryption).

Alright, since a “breach” did not occur by sending an unencrypted email, did a HIPAA “breach” occur when the email was sent to the business associate?  The answer is “no” since the HIPAA definition of “breach” has an exception that states as follows:

“Breach excludes…any unintentional acquisition, access, or use of PHI by a workforce member…of a covered entity or a business associate, if such acquisition, access, or use was made in good faith and within the scope of authority and does not result in further use or disclosure in a manner not permitted under [the HIPAA Privacy Rule.]”

In this case, the business associate “acquired” the PHI by opening the e-mail, which was unintentional.  In other words, the business associate did not mean to acquire the PHI (as opposed to actively trying to gain access to information), and was acting within the scope of his/her employment, in good faith, and did not further disclose the PHI.  Thus, there was no HIPAA breach.

September 24, 2020

Posted on by hortyspringer

QUESTION:         May a physician be on-call for more than one hospital at the same time (take “simultaneous call”) or perform elective surgeries while on call?  If so, is that physician required to identify a specific back-up physician who will take calls at our hospital if the original physician is called to another hospital or is in the middle of an elective surgery when called by our hospital?

 

ANSWER:           CMS doesn’t specifically require that another physician be identified to take back-up call if the original on-call physician is performing elective surgery or is taking call at another hospital when the ED needs assistance.  Instead, CMS says that a “back-up plan” must be in place.  Per CMS, “some hospitals may employ the use of ‘jeopardy’ or back-up call schedules,” indicating that other hospitals may choose to not use back-up call schedules.  Here’s the full quote from the EMTALA Interpretive Guidelines (found in Appendix V of the Medicare State Operations Manual):

The [hospital’s] policies and procedures must also ensure that the hospital provides emergency services that meet the needs of an individual with an EMC [Emergency Medical Condition] if the hospital chooses to employ any of the on-call options permitted under the regulations, i.e., community call, simultaneous call, or elective procedures while on-call. In other words, there must be a back-up plan to these optional arrangements. For instance, some hospitals may employ the use of “jeopardy” or back-up call schedules to be used only under extreme circumstances. The hospital must be able to demonstrate that hospital staff is aware of and able to execute the back-up procedures.

https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_v_emerg.pdf

Of course, a hospital may decide that it’s On-Call Policy will not permit simultaneous call or elective surgeries while on call.  Or, a hospital’s policy may require on-call physicians to identify a specific individual to provide back-up coverage in such cases.  The key is to clearly identify the requirements in the hospital’s On-Call Policy.

September 10, 2020

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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.

September 3, 2020

Posted on by hortyspringer

QUESTION:        In the Davidson v. Glenny case described in this week’s Health Law Express, the appellate court did not apply statutory immunity to the faculty members involved in the reappointment process because the immunity was conditioned on “good faith.”  Are there other, stronger protections for our medical staff leaders when they are engaged in credentialing and peer review?

ANSWER:            Yes, while many state statutes providing immunity for those involved in the medical staff processes, such as credentialing and peer review are conditioned on “good faith” or “lack of malice,” the federal Health Care Quality Improvement Act (“HCQIA”) provides stronger protections for medical staff leaders.  Before we tell you about those protections, the reason that the “good faith” and “absence of malice” conditions are concerning is because they are factual issues.  Whether someone acted in good faith, for example, is an issue that usually is determined by a jury.  When a physician files a suit claiming they were wronged by an adverse action, the physician generally has their own side of the story, typically involving allegations of unfair treatment or instances of medical staff leaders acting in bad faith.  If that is the case, the jury weighs the evidence of the physician against the evidence of the hospital and/or medical staff leaders and concludes whether the action was taken in good faith and the immunity should apply.  The bottom line is that this makes it more difficult for medical staff leaders who are named in a suit to be dismissed from the suit at an earlier stage.

The immunity under the HCQIA is different.  The courts, generally, recognize this.  For example, the Supreme Court of Pennsylvania, in a case called Manzetti v. Mercy Hospital of Pittsburgh instructed that “In an HCQIA action, plaintiffs are not permitted to introduce evidence of bad faith of the participants in the peer review process…the alleged bad faith of the participants in the peer review process is immaterial to determining whether these participants are entitled to immunity under the HCQIA.”  That being said, there are requirements embedded in the HCQIA that have to be met for immunity to apply.  Nonetheless, the distinction described in the Manzetti case makes the federal law stronger than most state immunity laws.

Another tool to enhance protections for your Medical Staff leaders is to include solid immunity language in your application form and Medical Staff documents.  By way of example, your application should provide as follows:

As a condition of applying for appointment, to the fullest extent permitted by law, the individual releases from any and all liability, extends immunity to, and agrees not to sue the Hospital, the Board, and the Medical Staff, their authorized representatives, any members of the Medical Staff or the Advanced Practice Clinician Staff, or Board, and any third party who provides information.

This immunity covers any actions, recommendations, reports, statements, communications, or disclosures that are made, taken, or received by the Hospital, its representatives, or third parties in the course of credentialing and peer review activities or when using or disclosing information.  Nothing herein will be deemed to waive any other immunity or privilege provided by federal or state law.

For more information on the legal protections available to Medical Staff leaders, join Lauren Massucci and Charlie Chulack for the Horty, Springer & Mattern virtual seminar, Credentialing for Excellence on November 19 & 20, 2020.

August 27, 2020

Posted on by hortyspringer

QUESTION:        Are there new Medicare Conditions of Participation (“COPs”) for hospitals and critical access hospitals (“CAHs”)?

ANSWER:          Yes. As background, on March 4, 2020, CMS issued guidance stating that hospitals should inform certain individuals and entities regarding persons who have COVID-19. This week, as alluded to in Your Government at Work, CMS issued an interim final rule (“IFC”) which requires hospitals and CAHs to report data regarding COVID-19 in a standardized format. The new COPs are at §§ 482.42(e) for hospitals and 485.640(d) for CAHs, and the purpose is to track the incidence and impact of COVID-19 to help public health officials detect outbreaks.

The IFC emphasizes that the new COPs “do not relieve a hospital or a CAH, respectively, of its obligation to continue to comply with §§ 482.42(a)(3) or 485.640(a)(3), each of which requires a facility to address any infection prevention and control issues identified by public health authorities.”

The new COPs will become effective once the IFC is published in the Federal Register.