October 15, 2020

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

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

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

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.


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 17, 2020

QUESTION:        Some big drug companies sent letters to our hospital saying that they would stop selling us 340B drugs unless we participate in the 340B “ESP” program and give them specific claims information.  Is this legal?


ANSWER:          There is some question as to whether drug companies can condition the sale of 340B to submitting this kind of information.  The letters we have seen cite concerns about duplicate discounts between the Medicaid and the 340B program. These requests also raise serious questions about whether the disclosure of claims information would comply with HIPAA unless the protected health information is de-identified – which is easier said than done – or the drug companies sign business associate agreements – which is unlikely. The American Hospital Association recently sent a letter to the Secretary of HHS in opposition to these requests. Some of the requests set a deadline of October 1 for compliance, but it is doubtful that the matter will be resolved by then.  Stay tuned for further developments.  For more information, contact Henry Casale at hcasale@hortyspringer.com or 412-687-7677.

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.

September 3, 2020

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

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.

August 20, 2020

QUESTION:        Do quorum requirements apply when a Medical Staff committee or department takes action via “ballot” rather than by holding a meeting?  Our Bylaws language authorizes us to take action by email, written, and electronic balloting, which our committees have been relying on more often in light of the COVID crisis.

We are hoping to hold our annual meeting this September via Zoom meeting and, for the sake of keeping that meeting as short and efficient as possible, move all action on Bylaws and policy amendments out of the meeting, to be conducted instead by electronic ballot.  Before we do that, we want to make sure we aren’t going to have to receive a majority reply in order to satisfy our quorum.  I don’t think we could achieve a majority response.


ANSWER:          For the most part, the way a Medical Staff provides notice of its meeting, the quorum requirements that apply, and its procedures for voting on matters are all entirely within its discretion.  So, the best answer about whether quorum requirements apply to votes taken by ballot is:  Check your Bylaws and other governance documents. 

It’s common for Medical Staff Bylaws to include language addressing how meetings are held, whether members can participate in meetings via telephone or electronic connection, what constitutes a quorum, and the number of votes necessary to pass a particular action.  Sometimes, when such provisions have been updated piece meal over the years to address action without a meeting (such as by ballot voting), the connection may not have been made about whether the quorum requirements (traditionally defined as a certain percent of members present at a meeting) apply to votes taken by ballot.

If, after consulting the Bylaws, you find that your documents solve the problem — great!  But, if not, maybe you can use the upcoming meeting as an opportunity to revise your quorum/meeting provisions to specifically address the matter.  One option for solving your dilemma would be to make “Quorum” a defined term within all of your Medical Staff documents.  Consider the following definition as a starting point:

“QUORUM” means, unless specifically stated otherwise, those Medical Staff Members with the prerogative to vote and who are either (a) the voting members Present (but not fewer than two members) at any regular or special meeting of the Medical Staff, department, division, committee, or other body, or (b) the voting members of the Medical Staff or any department, division, committee, or other body, as applicable, who return a response to a vote presented via mail, facsimile, e-mail, hand delivery, website posting, or telephone.  Exceptions to this general definition of Quorum (e.g. those members Present or returning a vote) exists as follows:

(a)        for meetings and votes of the Medical Executive Committee, the Credentials Committee, and the Committee on Professional Enhancement, where the Presence (or return of a response, in the case of voting via mail, facsimile, e-mail, hand delivery, website posting, or telephone) of at least __% of the voting committee members will constitute a Quorum; and

(b)        for amendments to the Medical Staff Bylaws that are presented to the Medical Staff via mail, facsimile, e-mail, hand delivery, website posting, or telephone (which require __% of the voting members of the Medical Staff to return a response in order to satisfy the Quorum requirement).

August 13, 2020

QUESTION:          Are you aware of anything new on the Proposed Stark Rules and Anti-Kickback Safe Harbors?  If they are adopted now, is there anything that could affect those rules from going into effect?


ANSWER:           The answer to both of your questions is yes.

You are referring to the proposed regulations to the Stark Law and the proposed safe harbor regulations to the Medicare Anti-Kickback Statute that were proposed on October 17, 2019.  The notice and comment period for these rules ended on December 31, 2019 (click the links below to read our comments on these rules).

Comments on Proposed Safe Harbor Regulations (File Code OIG-0936-AA10P)

Comments on Proposed Regulations to the Physician Self-Referral Law (File Code CMS-1720-P)

Supplement to Comments on Proposed Regulations to the Physician Self-Referral Law (File Code CMS-1720-P)

While the rules have not been published in final form, according to a July 21, 2020 posting by the Office of Management and Budget, those regulations are under review by OMB and it is our understanding that these rules remain a high priority for CMS.

The proposed rules provide practical, realistic guidance for compliance with both the Stark law and the Medicare Anti-Kickback Statute.  It is our hope that both sets of regulations are published in final form in much the same form as proposed.

But here is where life gets complicated.  Due to a provision in a little known law called the Congressional Review Act (“CRA”) and the upcoming Presidential, House and Senate elections, publication of those rules in final form at this late date in the Trump administration may not be enough for them to remain in effect.

The CRA was enacted in 1996.  The provision in the CRA to keep an eye on is the section of the CRA that applies to regulations that are published within 60 legislative days of the end of a presidential term (which has long passed).

The CRA requires regulatory agencies to submit their rules, regulations, and guidance documents to Congress before they can officially take effect.  Congress has 60 legislative days to review a rule.  If Congress does nothing, then the rule takes effect.  However, if a simple majority in the House and the Senate (filibuster rules do not apply) do not like the rule/regulation/guidance, they can issue a “resolution of disapproval.”  Once the “resolution of disapproval has passed, unless it is vetoed by the President, the rule/regulation/guidance document is dead.

It is important to note that as a practical matter, the CRA will only be relevant if there is a change in the President, the Democrats hold the House and the Democrats flip the senate.  If that does not occur, then it will be virtually impossible to get the votes necessary for the CRA to apply.

Prior to the Trump Administration, the CRA was only used once.  However, after President Trump was elected and the Republicans held a majority in the House and Senate, the CRA was used 14 times to invalidate Obama/Biden Administration enacted rules.  It will be interesting to see if the Democrats will do the same if they are given the chance and whether the Stark rules and/or the Safe Harbor regulations will be a victim of the CRA.