February 18, 2021

QUESTION:        We entered into an exclusive contract with an anesthesia group, and were wondering whether we can require the anesthesiologists and other group personnel to submit to drug and alcohol testing?

ANSWER:           Yes – as long as testing is addressed in the contract.  Since exclusive contracts are usually between the hospital and the group – and not with the individual physicians of the group – only the group itself is actually bound by any requirements set forth in the contract.  Therefore, it’s important that the contract language state that each of the group’s physicians, as a condition of providing services at the hospital under the contract, shall be free from the influence or presence of alcohol or drugs and that this shall be enforced by the group, which shall conduct testing of its physicians at the time of conditional offer of employment, following a reasonable suspicion of use or abuse, and upon return to work after a leave of absence for drug or alcohol treatment.  This approach can be reinforced by requiring every physician of the group to sign an agreement to be bound by all the terms of the hospital’s contract with the group (and the contract should state that the group will require each physician to sign such a statement as a condition of employment).  Also, a hospital and its medical staff can achieve a similar result by having drug and alcohol testing requirements in the bylaws or another medical staff policy.  Since a group’s physicians would have to be appointed to the medical staff and granted clinical privileges in order to practice at the hospital, the group’s physicians would have to comply with any requirements in the bylaws or other policies, including those for drug and alcohol testing.

February 11, 2021

QUESTION:        I hear that the new Stark regulations have a way that Stark violations can be corrected without penalty.  Is that so?

ANSWER:           Yes, within limits.  CMS has now given hospitals and doctors a new way to correct noncompliance with the Stark law without having to make a self-disclosure.  The regulations, which became effective on January 19, 2021, contain a new regulation at 42 CFR §411.357(h) that allows parties to a compensation arrangement to reconcile all discrepancies while a contract is in effect or up to 90 days after it terminates so long as after the reconciliation the arrangement fully complies with all elements of the applicable exception.

For example:  say a hospital contract with a medical director calls for payment at $140 per hour but the doctor is paid $150 per hour.  If $150 still is within FMV range, all that is necessary is to reflect that in amendment going forward.  If the amount actually paid exceeds fair market value, the contract can be amended to recoup payments in excess of FMV via an offset against amounts due in the future (e.g., a payroll deduction) while the relationship is in effect, but the entire amount of the excess must be recouped within 90 days after the contract ends.

CMS also said that not every error will cause a financial relationship to be out of compliance with Stark nor must every mistake or error be corrected in order to maintain compliance.  Administrative and operational errors that are identified and rectified in a timely manner will not cause a relationship to be out of compliance.  In addition, CMS said that not all transfers of remuneration create compensation arrangements.  Examples include mistaken payments that are never identified, theft, use of office space not in lease, use of equipment beyond the expiration of the lease term or slight deviation from written agreement such as a one-time incorrect rental payment.

This new option is a great alternative to resorting to the Stark self-disclosure protocol.  To learn more about it, stay tuned for an upcoming Health Law Expressions podcast, where Horty Springer attorneys Josh Hodges and Dan Mulholland will discuss this new rule, or e-mail them at jhodges@hortyspringer.com or dmulholland@hortyspringer.com.

 

February 4, 2021

QUESTION:        Our Medical Staff Bylaws contain a provision stating that Medical Staff members automatically relinquish their appointment and clinical privileges if they lose their license or fail to meet other threshold eligibility criteria.  Do we have to report such automatic relinquishments to the National Practitioner Data Bank (“NPDB”)?

 

ANSWER:          You do not.  By way of background, we generally recommend that Medical Staff Bylaws documents identify certain events that will lead to the automatic relinquishment of appointment and clinical privileges.  This includes, among other things, failure to meet any threshold eligibility criteria that are required for appointment and clinical privileges.  When a member’s appointment and privileges are automatically relinquished pursuant to such a provision, the action is considered to be “administrative” in nature.  That means there is no “professional review action” as defined by the Health Care Quality Improvement Act, so there is no need for a report to the NPDB.  The latest edition of the NPDB Guidebook includes the following question and answer that addresses this specific situation (See page E-47):

Question:  A hospital automatically revoked a physician’s clinical privileges when the physician lost her license.  Should this action be reported?

Answer:  No. Administrative actions that do not involve a professional review action are not reportable to the NPDB. The revocation of clinical privileges is automatic because the practitioner no longer holds a license.  Regardless of the reason for the State medical board’s licensure action, the hospital’s revocation of privileges was not the result of a professional review action.  Therefore, the hospital’s action should not be reported to the NPDB.

January 28, 2021

QUESTION:        Some states have allowed nurse practitioners and physician assistants to practice “independently.”  If our hospital is located in one of these states and does not permit these types of practitioners to provide services independently, can this be considered discriminatory?

 

ANSWER:          Many hospitals are struggling with these types of issues because of the need for practitioners to provide services and the expanding role and state scope of practice laws for advanced practice providers.  For example, several years ago, Oregon passed a law allowing nurse practitioners to perform vasectomies.  The law instructs that nurse practitioners “may” perform these types of procedures.  The key is that most of these laws are permissive and not mandatory.  In other words, in Oregon you may permit nurse practitioners to perform this procedure in, for example, an outpatient department of your hospital but you do not have to allow it.  Some hospitals, especially those in rural areas where it is difficult to recruit practitioners, view these state scope of practice expansions with enthusiasm and perceive them as an opportunity to provide needed services to underserved populations.

Even though we are unaware of any cases successfully challenging a hospital’s decision to take a more restrictive approach than what is permitted under the state scope of practice laws/regulations (e.g., only permitting physicians to perform certain procedures even though state law permits nurse practitioners to provide the service), any decision to grant clinical privileges must take into account, among other things, the practitioner’s current competence to perform the privileges.  If a practitioner is unable to demonstrate current competence and meet any other threshold criteria, as specified in your delineation of privileges form, he or she would not be eligible for a grant of those privileges regardless of what that practitioner’s state scope of practice says.

By way of comparison, a medical license provides a physician with an almost unlimited scope of practice.  Yet routinely hospitals limit the scope of practice for physicians by the privileges that are granted and not granted.  The same would be true for advanced practice providers.

To help avoid a legal challenge, it’s a good idea to document the reasons underlying a decision to take a more restrictive approach to the grant of privileges.  For instance, there may not be a need in the community for the service because that need is already being met.  Your documentation should also reflect that conflicts of interest were appropriately managed and that the reasons were not based on discriminatory intent or purpose.

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.