January 21, 2021

QUESTION:        I’ve heard that the Centers for Medicare & Medicaid Services (“CMS”) has recently begun a new program called “Acute Hospital Care at Home.”  Can you explain more about this?  Is this related to the Hospitals without Walls initiative?

 

ANSWER:          The Acute Care Hospital at Home program builds upon Hospitals without Walls, which provided broad regulatory flexibility to allow hospitals to provide services in locations beyond their existing campus.  After considerable study and research, CMS determined that over 60 different acute conditions could be treated appropriately and safely in home settings with proper monitoring and treatment protocols.

Note that this is different from more traditional home health services.  Acute Hospital Care at Home is for beneficiaries who require acute inpatient admission to a hospital and who require at least daily rounding by a physician and a medical team monitoring their care needs on an ongoing basis.

In late November, there were six health systems who had received approval for new waivers under the program.  By mid-January, the program had expanded to include 88 hospitals across 24 different states.

To enter the program, hospitals must submit a waiver request to CMS.  There is an abbreviated process available, but most hospitals will be required to submit a detailed waiver request.  As part of this request, the hospital will need to show that it can provide or contract for services such as:

  • Pharmacy
  • Infusion
  • Respiratory Care (including oxygen delivery)
  • Diagnostics (labs, radiology)
  • Monitoring (with at least 2 sets of patient vitals daily)
  • Transportation
  • Food Services (including meal availability as needed by the patient)
  • Durable Medical Equipment
  • Physical, Occupational, and Speech Therapy
  • Social Work and Care Coordination

More information is available on the CMS website, including an FAQ document.  CMS also held a conference call on December 22, 2020, which explained further details of the program (transcript and recording available here).  We expect that more information will be made available in the near future as the program evolves.

January 14, 2021

QUESTION:        We have a multi-specialty peer review committee that handles day-to-day peer review activities.  What kind of reports and information should that committee provide to the Medical Executive Committee (“MEC”)?  Specifically, should the multi-specialty peer review committee provide practitioner-specific details of its reviews to the MEC?

 

ANSWER:          We recommend that the MEC (and the Board) not be provided detailed, practitioner-specific information about individual cases that the multi-specialty peer review committee is handling.  There are several reasons for this recommendation:

  • If a performance concern cannot be successfully resolved by the peer review committee, the matter will be referred to the MEC (and possibly from there to the Board). The role of the MEC and Board would be to conduct a meaningful, non-biased review of the matter.  Essentially, they serve as appeal bodies.  If they have been receiving detailed, practitioner-specific reports throughout the review process, the physician under review will allege that the MEC and Board have “pre-judged” the matter and were biased by receiving one-sided reports from the peer review committee.
  • The MEC and Board are the only bodies who may recommend or take disciplinary action with respect to a physician (i.e., an action that leads to a hearing and a report to the state board of medicine and the National Practitioner Data Bank). To change the perception of peer review from “disciplinary and punitive” to “educational and constructive,” it makes sense to keep practitioner-specific details away from the two bodies who are responsible for potential discipline.  Physicians who are being reviewed may be more collegial and willing to participate in performance improvement efforts if the details of these efforts are not routinely shared with the MEC and Board – especially when there is nothing for the MEC or Board to approve or act upon.
  • Using the multi-specialty peer review committee to handle performance issues makes clear that the effort is part of the hospital’s routine peer review process. It is not a “precursor” to disciplinary action, which helps to clarify NPDB reporting obligations.
  • Providing practitioner-specific details to 20 – 30 MEC and Board members undermines assurances to Medical Staff members that the peer review process is confidential, and that information will only be shared with those who have a “need to know.”
  • The MEC and Board can satisfy their legal responsibilities to oversee the peer review process by reviewing aggregate, anonymized reports regarding the activities of the peer review committee. No practitioner-specific details are required.

Join Paul Verardi and Phil Zarone on March 2, 2021 as they discuss this issue during Building an Effective PPE/Peer Review Process:  “Survey Says…”

 

January 7, 2021

QUESTION:        We recently had an applicant disclose that she was convicted for embezzling funds from an employer twelve years ago and served five months in a minimum security prison as part of her penalty.  Because the conviction occurred prior to the individual beginning medical residency training, it did not render her ineligible for consideration under our threshold eligibility criteria, which state (as relevant):

Since the start of medical or professional training, the individual must have not been convicted of, or entered a plea of guilty or no contest to, any felony or to any misdemeanor related to controlled substances, illegal drugs, violent acts, sexual misconduct, moral turpitude, domestic, child or elder abuse, or Medicare, Medicaid, or other federal or state governmental or private third-party payer fraud or program abuse, nor have been required to pay a civil money penalty for any such fraud or program abuse;

We processed the application, after getting substantial information from the applicant about the conviction and the steps she had taken to reform her conduct to ensure no reoccurrence.  But, this situation got us wondering whether we should make our threshold criteria more stringent.  Wouldn’t it be better to exclude, as a matter of course, all individuals with a felony background and then individually, on a case-by-case basis determine whether to make an exception and let them apply?  Though I think we ultimately reached a good outcome with this applicant, I’d be lying if I said that the prospect of denying the application and having to hold a hearing wasn’t on our minds.

 

ANSWER:          Processing applications from those with interesting backgrounds is the most difficult task that credentialers face.  When an applicant has something very concerning in their background, it often falls within the “eligibility criteria” set forth in the organization’s Medical Staff Bylaws – and renders the individual completely ineligible to have the application subjectively considered.  That’s easy!  When the applicant, like 99% (or more) of the applicants has nothing but good things in their background, subjective consideration requires very little scrutiny.  That’s easy!  But, the gray areas in between:  That’s hard.  And that’s where you found yourself with your applicant – a felon with a notable conviction and some prison time, but whose crime occurred a number of years ago, prior to medical training.

If the culture of your organization is such that, in virtually all cases (90% +), you would not want to even consider granting Medical Staff membership (or privileges) to an individual who has a certain characteristic – and that characteristic is reasonably related to the practice of medicine or the fulfillment of the responsibilities of Medical Staff membership – you should consider adding the characteristic to your threshold criteria.  With respect to criminal background, some organizations feel differently than others with respect to how the threshold criteria should be defined.  Some wish to include all felonies, no matter when they occurred and no matter whether they are certain types of crimes.  The thought in such organizations is that a felony is serious enough to call into question the individual’s judgment and reputation, no matter the other circumstances.  Other organizations, like yours, define the threshold criteria more narrowly, perhaps limiting those relevant to crimes to felonies that occurred within the past 5 or 10 years, or to felonies that relate to the practice of medicine (e.g. those related to violence, treatment of vulnerable people, fraud, insurance, etc.).  There are many, many variations out there.  If your organization feels that the existing language of the Medical Staff Bylaws (or Credentials Policy) is too narrow – and lets through too many applicants who should not be receiving consideration – then it’s time to open a dialogue on the matter and consider revisions.  Threshold criteria are not static!  They should be modified as necessary to achieve the goals of the organization.  Further, one of the reasons for a separate Credentials Policy, if you use it, is to allow the detailed credentialing criteria to be more easily modified to reflect the organization’s changing culture and goals.

Note, however, that threshold criteria are not meant to be used to prevent credentialers from using their judgment and expertise to carefully weigh the credentials of applicants who come with some background.  If the culture of your organization is that you would sometimes consider granting Medical Staff membership and/or privileges to an individual who has a certain characteristic, such as a felony conviction, but it depends on the type of conviction, how long ago the conviction occurred, the mitigating steps taken by the applicant to address the matter, the applicant’s assumption of responsibility, finite steps taken by the applicant to prevent recurrence, etc., then your threshold criteria may be just right.  In other words – you need not use the threshold criteria to screen out, as “ineligible,” those individuals who you would sometimes (often) consider for appointment or privileges.  Rather, you can use the standard credentialing process to weigh such individuals’ qualifications and make a subjective decision.  The credentialing process, which usually includes several layers of consideration is uniquely designed to promote careful consideration of each application – particularly in cases where something notable is found in the applicant’s background.

Of course, the standard credentialing process does come with the prospect of a “denial,” with the attendant costs of hearing and appeal rights.  So, why not adopt threshold criteria that are more stringent than you would sometimes like to enforce and then grant case-by-case exceptions?  The reason is that each failure to enforce the threshold eligibility criteria undermines the eligibility process generally.  The whole point of having objective eligibility criteria is to define objective factors that are less susceptible to biased implementation (do to them being objective and, in turn, easily discernible through reference to external sources).  Because bias is so limited in such situations, and subjective consideration is not required, eligibility determinations do not constitute judgments about an individual’s competence or conduct and, therefore, do not constitute “adverse professional review actions.”  It is adverse professional review actions that give rise to due process rights.

While we do generally recommend including in the Bylaws/Credentials Policy a process for granting waivers to those who fail to satisfy threshold criteria, we also recommend that the process be utilized only when exceptional circumstances exist – circumstances that are so significant they rule out the concern raised by the threshold criterion at issue (for example, a foreign-trained physician convicted of a crime equivalent to a felony in his home country, during a time of political upheaval and related to political activism would be a good choice for waiver, because the type of criminal conviction at issue does not raise concerns about reputation or judgment, in the way that most other criminal convictions would).

Importantly, however, if the waiver process is intended to be used – or is actually used – to grant waivers more routinely (for example, you find that 27% of reappointment applicants are being granted waivers of board recertification/MOC requirements after requesting waivers on the basis that they didn’t have time to get around to MOC), then the criterion is probably overly broad and should be modified until the organization is comfortable applying the criterion almost uniformly.  That eliminates as much subjectivity as possible/practicable, lending credence to the eligibility process generally.

December 17, 2020

QUESTION:        We use the MGMA 75th percentile of compensation per wRVU as a fair market value benchmark for our physician employment contracts.  Is that still OK?

 

ANSWER:          Not necessarily. The amendments to the Stark regulations published in the Federal Register on December 2, 2020 set forth a more fluid definition of “fair market value”  that calls into question whether hospitals need to be wedded to salary surveys like the MGMA.  The new definition of FMV in the context of compensation arrangements provides as follows:

“Fair market value means— (1) General. The value in an arm’s length transaction, consistent with the general market value of the subject transaction….General market value means— … With respect to compensation for services, the compensation that would be paid at the time the parties enter into the service arrangement as the result of bona fide bargaining between well-informed parties that are not otherwise in a position to generate business for each other.”

The commentary to the regulations said the following with respect to compensation surveys:

“It is not CMS policy that salary surveys necessarily provide an accurate determination of fair market value in all cases….  Consulting salary schedules or other hypothetical data is an appropriate starting point in the determination of fair market value, and in many cases, it may be all that is required. However, …a hospital may find it necessary to pay a physician above what is in the salary schedule, especially where there is a compelling need for the physician’s services…. [there is] a need for an analysis of the actual terms of a transaction and the actual facts and circumstances of the parties. In our view, each compensation arrangement is different and must be evaluated based on its unique factors.”

Therefore, you should look at all the facts and circumstances when determining the fair market value of physician compensation – not just compensation surveys.

Want to know more about the new Stark Regulations and Anti-kickback Safe Harbors?  Order a recording of our December 16 audioconference that explains the major changes that are about to go into effect by clicking here.

Need a check-up on your physician contracts or compensation polices, email Henry Casale or Dan Mulholland or call them at 412-687-7677. They’ll be happy to help.

December 10, 2020

QUESTION:        A physician employed by a nearby Federally Qualified Health Center recently applied for medical staff appointment at our hospital. Our medical staff bylaws require malpractice insurance coverage as a condition of appointment.  This physician does not carry insurance but says she has coverage under the Federal Tort Claim Act.  Should we make an exception for this physician?

 

ANSWER:          Yes. Hospitals are prohibited by federal law from denying appointment or privileges to physicians who have coverage under the FTCA.  The Public Health Service Act, at 42 U.S.C. §233(j) says:  “In the case of a health care provider who is an officer, employee, or contractor of [a public or non-profit private entity receiving federal funds under National Health Services Corps programs], section 254h(e) of this title shall apply with respect to the provider to the same extent and in the same manner as such section applies to any member of the National Health Service Corps.”  Section 254h(e) says:  “It shall be unlawful for any hospital to deny an authorized Corps member admitting privileges when such Corps member otherwise meets the professional qualifications established by the hospital for granting such privileges and agrees to abide by the published bylaws of the hospital and the published bylaws, rules, and regulations of its medical staff.”  The penalty for violating this section is denial of the hospital’s eligibility to receive Medicare and Medicaid funds.

Therefore, a waiver of the malpractice insurance eligibility criterion would be advisable for this physician so long as she continues to have FTCA coverage.  You may also want to consider amending your bylaws to provide exceptions for providers who fall into this category as long as they continue to have FTCA coverage.

 

 

December 3, 2020

QUESTION:        We have an applicant for medical staff appointment who disclosed that he was under probation for a time during his residency. Despite our requests, he has refused to provide any additional information related to this matter. He also has declined to sign an authorization that would allow us to talk freely with his program director.

We have language in our Medical Staff Credentials Policy stating that the burden is on the applicant to provide any information requested, or his or her application will be held as incomplete.  Is this a situation where we can rely on this provision?

 

ANSWER:          Most definitely.  When it comes to enforcing such a provision, the law is on your side. Courts from jurisdictions across the country have held that a hospital can refuse to process an application that is incomplete.  For example, an Illinois appeals court, in a case with facts very similar to the situation described above, held that an applicant must

“provid[e] all information deemed necessary by the hospital…as a condition precedent to the hospital’s obligation to process the application.”

Similarly, an appeals court in Tennessee ruled in favor of the hospital in a case where a physician up for reappointment refused to release information on pending malpractice claims.  In that case, the court found that that application for medical staff membership clearly required the physician to assist in providing the information necessary to determine his qualifications.

Of course, having good language in your Medical Staff documents (and on your application form) that makes it clear that the burden to provide information is on the applicant – and that an incomplete application will not be processed – is key.  Since you stated that you have this language in place, you can feel confident in holding this application as incomplete until the applicant meets his burden of providing the information you need.

November 19, 2020

QUESTION:        We have an applicant for medical staff appointment who is over 80 years old. Are there certain things we can require during the credentialing process before he gets on staff?

 

ANSWER:           Let’s start with Henry’s favorite answer:  “It depends,” because it always does.

We recommend that Hospital Medical Staffs try to comply with the Americans With Disabilities Act (“ADA”) and Age Discrimination in Employment Act (“ADEA”) in the credentialing and recredentialing processes.  Whether the ADA and ADEA, which are both employment-based statutes, apply to the appointment process is still an open question.  But there are a number of cases, in reviewing these and other civil rights statutes, that have concluded there should be broad application of these laws and have applied them to the credentialing and recredentialing processes.

Furthermore, more and more physicians are employed, and these statutes will apply to your employed physicians.  It makes no sense to have two sets of rules in your credentialing process, one for employed physicians and one for private practice physicians (especially if the standard for private practice physicians is higher).  Therefore, we recommend that hospitals get as close as possible to compliance with the ADA and the ADEA, including in their appointment and reappointment processes.

Under the ADA, an employer is prohibited from requiring a health examination or making health-related inquiries until after a conditional offer of employment.  In the medical staff world, this means there can be no required physical examination and no health status questions until after the Credentials Committee has determined that an applicant is otherwise qualified to practice.

After the conditional offer, the employer is permitted to ask any health status questions and/or require a fitness for practice evaluation so long as it asks the same questions and requires the same evaluation for similarly situated applicants.  In the medical staff world, this means that after the Credentials Committee has made a conditional recommendation for appointment, a physical examination could be required and health status questions could be asked as long as this is the practice for all applicants.

If you do not typically ask health status questions or require a physical exam, you cannot do so just for the 80-year-old applicant.

There is an exception to this rule if a concern about a potential impairment is brought to your attention.  So, for example, if a peer reference raised a concern about the applicant’s cognitive impairment or eyesight or hearing or technical skills in the OR, you could follow-up.  The same would be true if during the interview the applicant was unsteady on his feet or confused.  Under these circumstances you would be permitted to follow-up on the health concerns and you could require a fitness for practice evaluation.

The ADEA would also prohibit you from making an appointment (or reappointment) decision based solely on the physician’s age.  The days of “congratulations on turning 75, you’ve been elevated to the Honorary Staff” are gone – as they should be.  It is worth pointing out that the requirement that a physician get a physical or cognitive exam based on the physician’s age (as some Late Career Practitioner Policies do) is being challenged by the EEOC.  See EEOC v. Yale New Haven Hospitalhttps://www.eeoc.gov/newsroom/eeoc-sues-yale-new-haven-hospital-age-and-disability-discrimination.  The challenge is based on both the ADEA and the ADA.

 

November 12, 2020

QUESTION:        The medical staff recently began an investigation of one of our employed physicians.  We have decided to exercise our right to terminate the physician without cause which, per the terms of his employment agreement, will result in the automatic expiration of his medical staff appointment.  Is this reportable?  Is there anything else we should consider?

 

ANSWER:          This situation is not reportable to the Data Bank.  How do we know – the Data Bank told us.  We also have some other recommendations that you should consider.

First, the termination of the Physician’s appointment due to the terms of an agreement is not reportable.  That is true even if the physician is under medical staff investigation at the time of the termination.

When asked about a similar situation, we received the following response and analysis from the Data Bank:

Response:

Regulations and Policies:

Under 45 CFR §60.12(a)(i), “[e]ach health care entity must report to the NPDB…[a]ny professional review action that adversely affects the clinical privileges of a physician or dentist for a period longer than 30 days.”

Under 45 CFR §60.3, a professional review action is “…an action or recommendation of a health care entity; 1) taken in the course of professional review activity; 2) based on the professional competence or professional conduct of an individual health care practitioner which affects or could affect adversely the health or welfare of a patient or patients; and 3) which adversely affects or may adversely affect the clinical privileges or membership in a professional society of the health care practitioner…” Additionally, a professional review activity under 45 CFR §60.3 is “an activity of a health care entity with respect to an individual health care practitioner…[t]o change or modify such privileges.” According to the NPDB Guidebook, the reporting entity generally decides when a professional review has occurred.

According to the NPDB Guidebook, “[a]dministrative actions that do not involve a professional review action should not be reported to the NPDB.”2 This point is illustrated in Q&A#2.3 In Q&A#2, the hospital used its employment termination procedures, not a professional review process, to revoke the practitioner’s clinical privileges. Since the hospital did not take the action through the professional review process, the revocation of the clinical privileges was not reportable.

Analysis:

In this scenario, the facility is terminating its employment arrangement with a physician due to the physician’s past non-compliance. The employment agreement requires that the physician relinquish his or her privileges if requested by the facility. Should the facility report the relinquishment of the privileges? Based on these facts, and similar to Q&A#2, the facility in this scenario is using its employment termination procedures to remove the practitioner’s privileges. Since it is using its employment termination procedures and not its professional review processes to remove the privileges, the relinquishment of the physician’s privileges would not be a reportable action.

(Emphasis added.)

We also have some practical advice for employers everywhere.  When preparing an employment agreement, give some thought to the length of the notice period to terminate the agreement without cause.  This period should be long enough to provide time to find a replacement, but not so long that it will create a financial strain on the employer’s finances if it decides to provide the physician with pay in lieu of working out the notice period (which is common).

While the decision to terminate the employment agreement must be made solely by the employer, the employer should make the medical staff committee involved in the investigation aware of its decision.  Also remind the Committee members that if they receive a request for a recommendation about this physician, they should inform Hospital management of the request.  The Hospital’s medical staff office should then inform the physician requesting the recommendation that no information will be provided without the physician executing a release that is specific to your hospital.

 

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.

October 29, 2020

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.”