Question Of The Week

December 21, 2023

Posted on by jwilbert

QUESTION:
I have always found the OIG’s past “Compliance Guidance” to be vague and not particularly helpful.  Is there anything more recent that will provide an analytical framework to comply with the Anti-kickback statute?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY HENRY CASALE:
The Anti-kickback statute is an intent-based statute.  So, the OIG can be forgiven to a certain extent for their “it depends” guidance on compliance with this law.  However, given the fact the Anti‑kickback statute is a criminal statute and that federal health care program claims resulting from a violation of this law will also constitute a violation of the False Claims Act, even the OIG has realized that more definitive guidance is required.

The OIG seems to have heard your plea for help, and has provided the following analytical framework for compliance with the Anti-kickback statute on Pages 12-14 of the November 6, 2023, OIG General Compliance Program Guidance (“GCPG”).

When attempting to identify problematic arrangements under the federal Anti-kickback statute, some relevant inquiries to explore and consider can include the following.  This list of questions is illustrative, not exhaustive, and the answers to these questions alone are not determinative as to whether an arrangement violates the federal Anti-kickback statute.

Key Questions:

(1)        Nature of the relationship between the parties –

        • What degree of influence do the parties have, directly or indirectly, on the generation of federal health care program business for each other?

(2)        Manner in which participants were selected –

        • Were parties selected to participate in an arrangement in whole or in part because of their past or anticipated referrals?

(3)        Manner in which the remuneration is determined –

        • Does the remuneration take into account, either directly or indirectly, the volume or value of business generated?
        • Is the remuneration conditioned in whole or in part on referrals or other business generated between the parties? Is the arrangement itself conditioned, either directly or indirectly, on the volume or value of federal health care program business?  Is there any service provided other than referrals?

(4)        Value of the remuneration.

        • Is the remuneration fair market value in an arm’s-length transaction for legitimate, reasonable, and necessary services that are actually rendered?
        • Is the entity paying an inflated rate to a potential referral source? Is the entity receiving free or below-market-rate items or services from a provider, supplier, or other entity involved in health care business?
        • Is compensation tied, either directly or indirectly, to federal health care program reimbursement?
        • Is the determination of fair market value based upon a reasonable methodology that is uniformly applied and properly documented?

(5)        Nature of items or services provided.

        • Are the items and services actually needed and rendered, commercially reasonable, and necessary to achieve a legitimate business purpose?

(6)        Federal program impact.

        • Does the remuneration have the potential to affect costs to any of the federal health care programs or their beneficiaries?
        • Could the remuneration lead to overutilization or inappropriate utilization?

(7)        Clinical decision making.

        • Does the arrangement or practice have the potential to interfere with, or skew, clinical decision making?
        • Does the arrangement or practice raise patient safety or quality of care concerns?
        • Could the payment structure lead to cherry-picking healthy patients or lemon-dropping patients with chronic or other potentially costly conditions to save on costs?

(8)        Steering.

        • Does the arrangement or practice raise concerns related to steering patients or health care entities to a particular item or service, or steering to a particular health care entity to provide, supply, or furnish items or services?

(9)        Potential conflicts of interest.

        • Would acceptance of the remuneration diminish, or appear to diminish, the objectivity of professional judgment?
        • If the remuneration relates to the dissemination of information, is the information complete, accurate, and not misleading?

(10)      Manner in which the arrangement is documented.

        • Is the arrangement properly and fully documented in writing?
        • Are the parties documenting the items and services they provide? Are the entities monitoring items and services provided?
        • Are arrangements actually conducted according to the terms of the written agreements (when written to comply with the law)?

Is this perfect guidance – No.  But it is a significant improvement over any compliance guidance that the OIG has provided in the past.  In fact, we find the OIG’s New General Compliance Guidance to provide an excellent framework for compliance with the Anti-kickback statute, and a number of other federal laws that affect health care providers.

If you have a quick question about this, e-mail Henry Casale at hcasale@hortyspringer.com.

For an in-depth discussion of the OIG’s November 6, 2023, OIG General Compliance Program Guidance, please check out the Horty Springer Health Law Expressions Podcast  “New OIG General Compliance Program Guidance by Dan Mulholland and Henry Casale.”

 

December 14, 2023

Posted on by Courtney Patterson

QUESTION:
Some of the physicians in our department are throwing a holiday party for staff.  It’s been a stressful year, and we are looking for a way to relax and have a little fun together.  We are planning on serving alcoholic beverages.  Is that a problem?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY SUSAN LAPENTA:
We appreciate your good intentions, and we don’t want to be the Scrooge who shuts down the party, but you do want to be careful.

We can’t count the number of times we’ve fielded calls from hospitals about work parties that turned into life-altering disasters with referrals to HR, Administration, Medical Executive Committee, Board, and the police.  Go ahead with the party (you might want to clear it with HR) but be careful and consider these practical tips:

  1. Make sure there is lots of food, so no one is drinking on an empty stomach.
  1. Make sure there are plenty of soft drinks, water, and coffee.
  1. Limit high-alcohol-content drinks and stop serving them in time for everyone to sober up for the drive home.
  1. Ask someone to serve as the equivalent of a designated driver to help make sure the drinking doesn’t get out of hand. No one expects the worst, but you should plan ahead.  Remember, calling an Uber is cheaper than the consequences by ten-fold.

Even parties that are held off-site could have serious work implications.  So, have some fun, enjoy yourself and your colleagues, and remember this sage advice: “everything in moderation.”

If you have a quick question about this, e-mail Susan Lapenta at slapenta@hortyspringer.com.

December 7, 2023

Posted on by Courtney Patterson

QUESTION:
I recently finished reading the equivalent of “War and Peace” also known as the minutes of our regular Medical Executive Committee meeting.  Do you have any tips for what to include in minutes?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY NICHOLAS CALABRESE:
We love a good novel, too, and apologies to Mr. Tolstoy, but, meeting minutes don’t have to be akin to a 1,225-page novel set during the Napoleonic Wars.  Here are the Top Ten Tips for what to include in minutes:

  1. DO – write down the name of the committee that’s meeting.
  1. DO – write down the date of the meeting.
  1. DO – list who’s in attendance, and who’s absent.
  1. DO – list if there are any guests or visitors at the meeting.
  1. DO – note the time the meeting was called to order, who called it to order, and the time it was adjourned.
  1. DO – note whether it’s a regular or special meeting of the committee.
  1. DO – note that if it’s a special meeting, that notice was given to the committee members, and the way notice was given.
  1. DO – note whether a quorum was present.
  1. DO – note whether the previous minutes were read and approved.
  1. DO – note the result of the votes, for example, 7‑1

And, here’s a bonus tip that was developed due to the pandemic:

  1. DO – record whether a meeting was a virtual meeting. Also, for this tip, reflect that all participants were reminded of the confidentiality, privacy and security provisions of policies.

If you have a quick question about this, e-mail Nick Calabrese at ncalabrese@hortyspringer.com.

November 30, 2023

Posted on by Courtney Patterson

QUESTION:
Our hospital is part of a regional system, and while there had been some low-level discussions about whether we may want to have a unified medical staff, the consensus was that we aren’t there yet – however, there is a strong desire for our medical staff processes to become more integrated even if unification isn’t our ultimate outcome.  Are there options short of formally becoming one unified medical staff?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY LEEANNE MITCHELL:
Absolutely!  While one of the main objectives of medical staff unification is consistency in core processes such as credentialing, privileging and peer review – with the goal towards promoting a single standard of care and reducing the administrative burden for the medical staffs and their leaders – many of these benefits can be obtained even in the absence of a unified medical staff.

A good first step is having similar (or identical) policies for credentialing, privileging and peer review at each system hospital that use the same eligibility criteria for appointment and privileges and the same process for evaluating applications among similar types of hospitals.  The same is true for policies governing clinical peer review, professionalism and health.  Consistent bylaws, policies and procedures across the system help the medical staff leaders to do their jobs, and are also helpful for members of the medical staffs who may practice at more than one system hospital to know what the rules are.

Even if a system has the same process for credentialing, privileging and peer review and has adopted the same standards for these activities, there remains the potential for different outcomes when different committees are making decisions.  Steps that the system and its medical staffs can take to address this concern – short of unification – include things such as:

  • Utilizing a central Credentials Verification Office to ensure each medical staff gets the same information about applicants;
  • Utilizing a system (or regional) Credentials Committee, which includes representation from all relevant hospitals, to avoid inconsistent recommendations being made by individual Credentials Committees on practitioners who are applying to more than one system hospital. The same goal can be accomplished in the peer review process by utilizing a system Peer Review Committee – a process that can be even more helpful when system hospitals include much smaller facilities that may have fewer individuals able to serve on such committees; and
  • Incorporating provisions into the medical staff bylaws/credentials policies for each system hospital which state that certain types of significant actions that directly implicate a practitioner’s qualifications to practice – such as performance improvement plans, precautionary suspensions, automatic relinquishments and final actions by the board – become effective immediately at each system hospital where the individual practices, unless the automatic action is waived by the “receiving” hospital’s MEC and the Board.

While these steps don’t achieve the same level of consistency that a unified medical staff would, they are definite steps along the “continuum of integration” that most systems are exploring and implementing.  Also, as the medical staff sees these integration steps in action, they can also help to quell the concerns that are sometimes voiced about possible unification and can be good first steps towards that goal.

If you have a quick question about this, e-mail LeeAnne Mitchell lmitchell@hortyspringer.com.

November 16, 2023

Posted on by Courtney Patterson

QUESTION:
In January, the Federal Trade Commission (“FTC”) issued a proposed rule that would ban almost all noncompete clauses imposed on workers, which includes employees and independent contractors, nationwide.  What’s the status?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY NICHOLAS CALABRESE:
The proposed rule has not been made final yet.  The FTC proposed the rule because it believes that non-competes are a violation of the Federal Trade Commission Act.  The proposed rule would prohibit an employer from: (1) entering into a non-compete with a worker; (2) maintaining a non-compete with a worker; or (3) representing to the worker that the worker is subject to a non-compete.  So, it would ban new non-competes and require that existing non‑competes be rescinded.  Also, the proposed rule would prohibit language that could act as a non-compete clause – a non-disclosure agreement that contains broad language, a provision that workers repay training costs if the worker leaves employment, or other language that bars workers from seeking other employment.

The FTC received over 20,000 public comments on the proposed rule.  Evelyn Wood herself would have had trouble wading through that many comments quickly, so at this point, the best guess is that the FTC will vote on the final rule in the Spring of 2024.  Another best guess is that the proposed rule, even if altered, will pass and become a final rule.  The final best guess is that the final rule will be challenged in court – no guess on how that litigation will turn out!  But, we will keep you updated.

If you have a quick question about this, e-mail Nick Calabrese at ncalabrese@hortyspringer.com.

November 9, 2023

Posted on by Courtney Patterson

QUESTION:
As a part of the threshold eligibility criteria in our Credentials Policy, physicians are required to be board certified by a board approved by the ABMS or AOA.  Can we accept certification by a foreign board from a physician who has applied for Medical Staff appointment and clinical privileges?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY CHARLES CHULACK:
This is a complex question since it may implicate other threshold eligibility criteria in your Credentials Policy.  For example, many medical staffs and hospitals also require a physician to have successfully completed a residency and, if applicable, a fellowship training program approved by the ACGME or AOA.  Thus, if a physician is board certified by a foreign board, it may also mean they did not receive their training in a residency approved by the ACGME or AOA and, consequently, do not meet that criterion as well.

Nonetheless, assuming all other threshold eligibility criteria are met, you may accept certification by a foreign board even though your Credentials Policy requires physicians to be board certified by an ABMS or AOA board.  However, you would first have to go through the waiver of threshold eligibility criteria process outlined in your Credentials Policy.  As an alternative, some hospitals with which we work that repeatedly come across this issue have incorporated a process in their Credentials Policy to use when evaluating whether a foreign board meets the standards of their hospital.  They consider whether the foreign board has comparable certification requirements, including those related to: (1) education and training; (2) letters of attestation or reference; (3) licensing; and (4) written and oral examinations.  A hospital may also give consideration to whether the foreign board is accepted by, for example, the relevant board of the American Board of Medical Specialties for purposes of qualifying for board certification in the United States (e.g., members of The Royal Australian College of General Practitioners are eligible to receive initial board certification through the American Board of Family Medicine) and if the Medical Executive Committee has previously determined that the foreign board meets the standards of the hospital.

It is also important to remember that the burden of demonstrating and producing information to support an applicant’s qualifications lies with the applicant.  This should be specifically stated in your Credentials Policy.  Therefore, if an applicant has certification by a foreign board, the burden is on them to provide information related to the factors described above for evaluating whether the foreign board meets the standards of the hospital.  If you have a quick question about this, e-mail Charlie Chulack at cchulack@hortyspringer.com.

November 2, 2023

Posted on by Courtney Patterson

QUESTION:
What’s this I hear about having to post a notice in all of our provider-based clinics that patients will be receiving a bill for facility fees?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY DAN MULHOLLAND:
It’s technically not required by law – yet.  But a lot of the Medicare Administrative Contractors are recommending it.  Here’s an example from Noridian. The provider-based billing rules, at 42 C.F.R. § 413.65, require that provider-based facilities hold themselves out to the public as part of the main provider.  When patients enter the provider-based facility or organization, they need to be aware that they are entering the main provider and are billed accordingly.  A poster like this is a good way to assure compliance with this requirement.

If you have a quick question about this or the provider-based rules in general, e-mail Dan Mulholland at dmulholland@hortyspringer.com.

October 26, 2023

Posted on by Courtney Patterson

QUESTION:
A new physician in a difficult to recruit specialty just fell into our laps.  When I asked my lawyer to prepare an Employment Agreement with a November 1, 2023 Starting Date, I was sent an agreement with a number of conditions that cannot possibly be completed in a week. Why must lawyers make these things so complicated?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY HENRY CASALE:
Your lawyer is doing you a favor.

The beginning of an employment relationship is not a simple matter.  The Employer must staff and equip an office for the new physician.  Not something that can be typically done in a week.  However, even if there is sufficient space and personnel for the new physician’s practice, don’t forget that all new employees, including physicians, must complete all required pre-employment screens – that takes time.

But what is often overlooked at the beginning of the legal relationship between a physician and his/her Employer is that since the Employer will be legally obligated to begin to compensate the physician as of the starting date of the agreement, as of that date, the Employer needs to make sure that the physician can perform all of the duties that are set forth in the agreement and (most important to the Employer) that the Employer will begin to be paid for the professional services that are provided by the new physician.

Many commercial insurers take 60-90 days to “credential” a new physician.  They also typically take the position that they have no legal obligation to reimburse the Employer for the professional services that are provided by that physician to the third party’s enrollees until that credentialling process has been completed.  If this process is not timed correctly, the Employer could be on the hook for up to three months of the physician’s salary with no revenue to cover that cost.

But let’s now look at the fact that a physician in a needed specialty fell into your lap.  I am not saying that this can never happen – but it is more likely than not, that this physician found themself in a situation where they were terminated from their old job and needed a new one fast.

You won’t know whether you are lucky, or stuck with a problem physician, until the Employer and the hospital’s credentialling processes have been completed.  Again, this takes time – time that is well spent!

Just as the Employer wants to be paid for the new physician’s services on their first day of employment, the Employer will also want that physician to be able to exercise clinical privileges as of that date as well.  That cannot happen unless the Agreement states that the Agreement does not begin until the hospital credentialling process has been successfully completed.

That is why we advise our clients that hiring is a process.  It takes time.  While you must be flexible, most hires require 60-90 days’ advance notice to set up the physician’s practice, to complete pre-employment screens, to credential the physician with third-party payers, and to allow sufficient time to complete the medical staff credentialling process.  The Agreement should require all of this to be completed by a date-certain, which is also the “Starting Date” of the Agreement and the date that the Employer has the legal obligation to begin to compensate the physician.

The Agreement should also specifically provide the Employer with the right to cancel the Agreement if the physician fails to complete this process in a timely manner, especially if that delay is caused by a clinical or behavioral concern that is discovered during the medical staff credentialling process.

While it is lawful to pay a reasonable signing bonus to a physician as soon as the physician signs on the dotted line, it is preferable not to be obligated to make any kind of upfront payment until the physician is on site and has begun to provide services as your employee.  However, if a signing bonus is paid before the physician begins to provide services, then the Agreement should make it clear that that upfront money must be repaid if the physician fails to start when required by the Agreement.  It is also a good idea to pro-rate the signing bonus so that a portion of that payment must be repaid if the physician does not remain employed for a minimum period of time.

If you have a quick question about this, e-mail Henry Casale at hcasale@hortyspringer.com.  If you want an in-depth discussion of Hospital-Physician employment relationships, compensating physicians and APPs, the Fraud and Abuse laws, the False Claims Act and much more, join me, Dan Mulholland and Hala Mouzaffar in Phoenix from November 16-18, for our Hospital-Physician Contracts and Compliance Clinic.

October 19, 2023

Posted on by Courtney Patterson

QUESTION:
Our hospital is in the process of refining our peer review process.  Our existing framework involves a multi-tiered review where cases are evaluated and assigned a level of complexity or concern, ranging from Level 1 to Level 4.  We are actively exploring enhancements to our current process.  Any suggestions?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY HALA MOUZAFFAR:
The peer review process is one of the most essential processes a hospital has in its toolbelt.  While a hospital’s peer review process should be tailored to fit its culture and needs, we do have some general guidelines that we suggest for everyone.

(1)        Ditch Numbering Systems
Reviewers should be assessing whether there was a concern with the care provided and how that concern could be addressed.  The problem with numbering is that no case ever fits neatly into one category.  So, more energy is put into deciding if a case is a 2 or 3 than what really matters in the review process (i.e., how to help a practitioner improve).

(2)        Incorporate Progressive Steps
Only rarely does peer review need to result in disciplinary action.  Some events can be addressed through a simple conversation or a letter educating the provider on what went wrong.  Other times, tools like performance improvement plans (for example, additional training) might do the trick.  Whatever you choose, your process should emphasize educational, collegial options with disciplinary action being the rare last resort.

(3)        Be Flexible
Do not create such a strict peer review policy that you box yourself in.  It’s not reasonable to create a rigid structure (i.e., first offenses will receive an educational letter, second offenses will receive a collegial conversation, etc.).  Make sure your process is constructed in a way that gives your peer review committee flexibility to identify the most effective performance improvement option under the circumstances.  A fundamental tenet should be to use the least restrictive option that will keep patients safe and help the practitioner to improve.  On the other hand, if a real red flag case comes through, you want to make sure your policy clearly states you can handle the case appropriately (by taking more significant action right away, if needed) instead of being required to work your way through each of the steps in the policy.

If you have a quick question about this, e-mail Hala Mouzaffar at hmouzaffar@hortyspringer.com.

October 12, 2023

Posted on by Courtney Patterson

QUESTION:
As of last week, we no longer maintain a contract with a particular insurer, resulting in a change of network status.  How do we handle patients who are now considered “out-of-network”?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY MARY PATERNI:
The No Surprises Act has anticipated this issue.  Moving forward, if a contract terminates between a plan and provider or facility, the NSA applies continuity of care protections to individuals who are considered a “continuing care patient” and who are in the process of receiving items or services from the facility for which their insurance would cover.

In the event a plan’s contract is terminated with a provider or facility, the plan will notify its enrollees who are continuing care patients.  These patients will have the right to elect continued transitional care from the provider and can choose to have the same benefits as they would have had under the plan had the contract not terminated.  This election would only apply to the course of treatment currently being furnished by the provider or facility that qualifies the individual as a continuing care patient.

If the patient elects to continue treatment with their provider or facility, then the provider or facility must (1) accept payment from the plan for items or services furnished to the continuing care patient as payment in full and (2) continue to adhere to the policies, procedures and standards imposed by the plan for the individual as if the termination has not occurred.

According to CMS, this election may continue for the earlier of 90 days from the time the patient is notified of the plan’s termination or until the date on which the patient no longer qualifies as a continuing care patient with the provider or facility.

As an example, if a pregnant woman learns at her next obstetrician appointment that her physician no longer maintains a contract with her insurance, she would be eligible for continuity of care protections because she is receiving ongoing treatment for her pregnancy.

If you have a quick question about this, e-mail Mary Paterni at mpaterni@hortyspringer.com.