Stark

November 4, 2021

Posted on by Courtney Patterson

QUESTION:
We know that we can provide a computer system that includes cybersecurity technology and related services to our employed physicians.  However, we have received several inquiries from independent members of our medical staff asking whether the Hospital can assist them to obtain cybersecurity technology and related services.  What can we do?

ANSWER:
By way of background, the Stark EMR Donation exception has, for many years, permitted a hospital to donate software, information technology and/or training services (but not hardware) to the physicians on the hospital’s medical staff so long as the arrangement is: (i) pursuant to a written agreement that specifies the items and services being provided; (ii) the software is interoperable; (iii) the donor does not affect the interoperability of the software; (iv) the physician pays 15% of the donor’s cost; (v) the receipt of the item or service is not a condition of doing business with the hospital; and (vi) neither the eligibility of a physician nor the amount of the donation is determined in a manner that takes into account the volume or value of referrals.

The January 19, 2021 Rules have amended the EMR Donation Rule to:  (i) permit the donation of cybersecurity software and services (but not hardware); (ii) delete the restriction that the arrangement does not violate the Medicare Anti-Kickback Statute; (iii) require the 15% share by the physician to be paid before the donation; (iv) delete the requirement that the donor does not have actual knowledge whether the physician receiving the EMR possesses equivalent items or services; and (v) eliminate the December 31, 2021 sunset on donations pursuant to this section.

Therefore, while this exception may be used, its limitations outweigh its usefulness, especially when compared to the new cybersecurity technology and related services exception that was added by the January 19, 2021 Rules.  The new exception will provide much more flexibility for a hospital that is interested in donating cybersecurity technology and related services to a referring physician.

This new cybersecurity technology and related services exception, 42 C.F.R. § 411.357(bb), protects nonmonetary remuneration (consisting of hardware, software, or other types of information technology and services) that are necessary and used predominantly to implement, maintain, or reestablish cybersecurity, if all of the following conditions are met:  (i) neither the eligibility of a physician for the technology or services, nor the amount or nature of the technology or services, is determined in any manner that directly takes into account the volume or value of referrals or other business generated between the parties; (ii) neither the physician nor the physician’s practice (including employees and staff members) makes the receipt of technology or services, or the amount or nature of the technology or services, a condition of doing business with the donor; and (iii) the arrangement is documented in writing.

Please note that a hospital is not required to provide cybersecurity items and services to every physician on the hospital’s medical staff.  Rather, a hospital is given discretion to select the recipients of its donated cybersecurity items or services, so long as the hospital complies with the above-stated requirements.

Unlike the EMR Donation Rule described above, this new exception permits the donation of cybersecurity hardware such as encrypted servers, encrypted drives and network appliances but only if the hardware is necessary and used predominantly to implement, maintain or reestablish cybersecurity.  If the donated technology includes functions other than cybersecurity, the core functionality of the technology and services must be implementing, maintaining or reestablishing cybersecurity and cybersecurity must predominate.

Also, unlike the EMR Donation Rule, the physician is not required to pay the 15% cost sharing required by the EMR Rule.  However, the cybersecurity item or service must be nonmonetary.  Therefore, a hospital could not reimburse a physician for the cost of previously obtained cybersecurity technology or services.  Nor would this exception permit a hospital to make a ransomware payment on behalf of a non-employed physician in response to a cyberattack.

June 3, 2021

Posted on by Courtney Patterson

QUESTION:   “I know that the Stark law covers a lot of seemingly innocuous activities. But surely Stark does not affect the ability of the MEC to serve food and drinks at an off-site medical staff meeting – Can it???”

ANSWER:      As you may have guessed – the answer is YES.  But, do not despair, there are several ways to comply with the law.

Any time that a hospital provides remuneration to a physician, the arrangement must satisfy an exception to the law.  Unfortunately, the Stark law defines “remuneration” so broadly that any meal or gift that a hospital provides to a physician will be considered to be “remuneration” and so the law will apply.  Once the law applies, you must find an exception that will permit the proposed conduct.

The fact that the meeting will he held off campus will limit the exceptions that might otherwise apply.  But even still, the good news is that the hospital gets to choose the exception that applies and depending on the facts, there are several exceptions from which to choose to address the meals to physicians provided at a committee meeting or at an educational event.  Also, you should be aware of a new Stark exception that became effective on January 19, 2021, that will be very helpful in situations such as what you have described.

Employed Physicians
The Stark law provides the greatest amount of latitude when a hospital provides the meal or other benefit to an employed physician.  Most meals and other medical staff benefits provided to an employed physician should be considered to constitute employment related fringe benefits and are covered by the Stark employment exception.

For the purpose of your question, we will assume that the Physicians who will receive the meals or other medical staff benefits are not Hospital employees – but we wanted to mention the Employment exception in case it can be used to minimize the record keeping that will be required by the exceptions that are described below.

Non-Employed Physicians
When dealing with non-employed physicians, the Stark law divides meals and other medical staff benefits into two categories – (1) non-monetary compensation that may be provided anywhere, have no individual per gift limit, but are subject to an annual cap; and (2) medical staff incidental benefits that must be provided on the hospital campus, have a per item limit but no annual limit.  Depending on the facts, other exceptions may apply as well.  However, the two meal related exceptions work like this:

(1)        Non-Monetary Compensation Exception
The “nonmonetary compensation” exception (42 C.F.R. §411.357(k)) permits compensation in the form of items, meals or gifts (but not cash or cash equivalents) that do not exceed the then applicable limit in any Calendar Year, adjusted for inflation.  When this exception was adopted, this amount was $300/Calendar Year.  However, this amount is annually adjusted for inflation and the annual limit for Calendar Year 2021 is $429.  CMS updates this amount annually, and the current annual limit may be found at http://www.cms.hhs.gov/PhysicianSelfReferral/10-CPI-U-Updates.asp.

Even when indexed to inflation, the $429 maximum in Calendar Year 2021 makes this exception of limited utility.  Furthermore, in order to satisfy this exception, the hospital must track all such items, meals or gifts, the item, meal or gift must not be determined in any manner that takes into account the volume or value of referrals or business generated by the referring physician and may not be solicited by the physicians.  However, there is no requirement that the meal or other benefit be provided on the Hospital’s campus.

In case it is needed, this rule also provides:  (1) no more often than once every three years, a physician who has inadvertently received non-monetary compensation of up to 50% in excess of the then applicable annual limit, may repay the excess within the earlier of the same Calendar Year or 180 days of receipt of the excess, but this exception may be used only once every three years with respect to the same physician.  In addition, a hospital may provide one medical staff function per year for the entire medical staff without regard to any monetary limit.

In order to comply with this exception, the hospital must track the value of all of the nonmonetary compensation that is provided to each physician during each Calendar Year.  However, this can be done by taking the cost of the event and dividing that cost by the number of physicians who attended (you do not need to track what each physician may eat).  Also, this exception does not include any geographic limitation.

(2)        Medical Staff Incidental Benefits
The other meal/gift related exception that applies to non-employed physicians is the “Medical Staff Incidental Benefits” exception (§411.357(m)).  While it is helpful that CMS has recognized that the Stark regulations should include an exception that recognizes a number of traditional relationships between a hospital and the physicians who are appointed to its medical staff, this exception is still relatively narrow and has a number of requirements, including the requirements that the item or services be offered to all staff members practicing in the same specialty without regard to the volume or value of their referrals to the hospital, provided only during periods when the medical staff members are making rounds or are engaged in other activities that benefit the hospital or its patients, used by the medical staff member “on the hospital’s campus,” be reasonably related to the delivery of medical services at the hospital, and not intended to induce referrals.

Also, the compensation must be of low value.  Originally, each item was valued at $25 or less, and subject to the same inflation adjustment used in the non-monetary compensation exception.  In Calendar Year 2021 this amount has been adjusted to $37 per occurrence.  Future updates can be found at the same area of the CMS website as the update for non-monetary compensation.  However, there is no annual limit and so there is not the same need for the per physician records to be maintained as there is for the above-described exception – but the hospital should keep records of the incidental benefits provided and their costs.

This is the so-called “free lunch exception.”  Therefore, assuming that all of the requirements to the exception are met, a hospital may provide free meals, free parking or any other “on campus” incidental benefit that it normally provides to all members of its medical staff practicing in the same specialty without fear that that benefit will be construed as a prohibited compensation arrangement, so long as each individual benefit (i.e., each meal) is less than $37 in 2021 even if the aggregate value of all of the benefits provided to a physician over the course of a year exceeds  $429 in Calendar Year 2021.  That said, based on the facts that you have provided (i.e., the off-campus location of the meeting), this exception will not apply.

(3)        Compliance Training Exception
There is a broad exception that permits a hospital to provide compliance training to a physician or to a physician’s staff, so long as the training is “held in the local community or service area” 42 C.F.R. §411.357(o) Compliance training is defined in this exception and is pretty broad – so it should apply to a medical staff committee meetings and most medical staff educational meetings. While the exception will permit the hospital to provide the training and CME so long as compliance training is the primary purpose of the program, this exception does not address serving food at the training.  While this exception should protect the training itself that you have described, we do not recommend relying on this exception to serve food at any such program.

(4)        Limited Remuneration to a Physician Exception – Added January 19, 2021
A new exception that became effective on January 19, 2021 will apply to a number of situations, including the one that you have described if none of the other exceptions apply. It does not require a written agreement, is very broad and permits a payment of up to $5,000 per Calendar Year per physician (with the $5,000/Calendar Year limit to be indexed to inflation in the same manner as the two exceptions described above).

Since this exception is new there is no case law interpreting.  However, it does not require a written agreement and is very broad.  While it has the disadvantage of requiring the hospital to track the amount paid to each physician each year (we recommend that you determine the amount/physician in the same manner described above), it will, in our opinion, cover the training that you described and much more.

We recommend relying on this exception first and should the $5,000/Calendar Year limit be exhausted then you may rely on the nonmonetary exception described above for the balance of the then applicable annual benefit.

March 18, 2021

Posted on by jwilbert

QUESTION:       I noticed that the first case in this week’s HLE discussed a Residency Assistance Agreement.  Does the Stark law permit a hospital to enter into such an agreement?  What are the practical and legal risks associated with such an agreement?

ANSWER:           Yes.  The Stark law permits hospitals to enter into a wide range of physician recruitment arrangements, either with the recruit or with a group that will employ the recruit.  A properly drafted recruitment agreement will comply with the Stark law, the Medicare anti-kickback statute and the IRS pronouncements on physician recruitment.

One unique form of recruitment agreement is to assist a physician financially during their residency program.  Such an agreement can be structured to comply with all legal requirements.  However, residency programs can last anywhere from three to seven years (as in the case discussed this week) and you are requiring a physician who is just beginning this training to make commitments that will extend for years after the training program has been completed.  As a result, inherent in this type of recruitment agreement are certain practical risks that often give rise to litigation.

A resident assistance agreement is typically an annual payment (usually a loan) that will be paid while the resident is in training but will then be forgiven if the physician returns and practices in the geographic area served by the hospital in the specialty described in the agreement for a certain period of time.

The situation in the case is not unusual.  There the physician entered into a five-year general surgery residency program.  The hospital agreed to pay her $25,000/year during the residency program.  While not stated in the case, this payment is typically a loan.  The physician agreed to return to the geographic area served by the hospital after the completion of the residency program, practice general surgery for a certain period of time (four years in the case) and if the physician practices in the manner described in the agreement for the full four years, the entire principal and interest will be forgiven.  Straightforward right – Not so fast.

Residents can change their mind – that is what happened in the case described in this week’s HLE.  There the physician wanted to pursue additional fellowship training as a thoracic surgeon.  However, not all hospitals need, or can support, such a subspecialist.  Besides, that is not what the hospital bargained for – they wanted a general surgeon.  Apparently, the hospital did not want to prevent the physician from obtaining the additional thoracic training but did not discuss the effect of her doing so on her commitment to the hospital.  Nor did they amend the agreement at the end of the general surgery residency program to address the change in circumstances.

So, they had an agreement that did not address the additional training.  As such, per its terms, the agreement stated that the physician would be in default if she did not practice general surgery for at least four years.  Apparently, that was not the physician’s understanding and she did not want to practice general surgery after obtaining additional training as a thoracic surgeon.  The result of this misunderstanding was litigation – which is still ongoing.  No general surgeon and legal fees-not the result that either party bargained for when they entered into the agreement.

Another issue that often arises in this kind of arrangement that often leads to litigation is how will the physician practice once they return.  If an employee what will their salary be and how will that salary be determined so far in the future?  If they are not offered employment by the health system, where will they practice and again under what terms?  The reality is that the physician has no idea of their market value before they start training but often become acutely aware as headhunters contact them as the training period ends – that complicates these employment-related issues.

We have also seen instances where a physician gets married during the residency program and their spouse either cannot find a job or does not want to live in the committed area.  Other issues arise if the hospital is sold, if demographic shifts have occurred so that the hospital can no longer support the physician’s specialty (even if the physician did not change or obtain additional training), or if unforeseen circumstances arise such as COVID.

Adding to this problem is that the amount of interest that accrues over the period of a lengthy residency program can be significant and can approach the amount of the principal – another fact that the physician did not realize when they signed the agreement.

So, what is a hospital to do?  Despite these issues, we continue to believe that a residency training assistance agreement is an excellent means for a hospital to recruit a new physician. It allows the hospital to recruit a physician in a needed service, although that need won’t be addressed until after the residency program is over.  It also allows the resident to concentrate on their training, eliminating the need to worry about whether there will be a position at the end of their training program.  It also assists the resident financially at a time when they often need the assistance.  But you need to appreciate the unique risks presented by this type of agreement, have an agreement that anticipates as many of those risks as possible, and if changes do occur during the course of the relationship, make sure that you memorialize those changes and their effect on the terms of the agreement in writing.

February 11, 2021

Posted on by jwilbert

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.

 

August 2, 2018

Posted on by hortyspringer

QUESTION:        I was just reviewing a contract to draft a second amendment and noticed that the original contract has the hospital as a party but the first amendment has the hospital’s physician group as a party.  What should I do?

ANSWER:            This doesn’t happen that often, but it does happen enough.  The good news is that it looks like you were watching the details when drafting the second amendment.

In any event, confirm which entity is to be the party in the contract.  It may be that the person who drafted the first amendment inserted the wrong party (or, conversely, the person who drafted the original contract had the wrong party).  Or, it may be that the contract was assigned by the hospital to the physician group, but you would not know that because the assignment was not included in the package of documents you were given to draft the second amendment.

The correct party is important for compliance reasons – for example, if the contract is supposed to be with an entity that qualifies as a “group practice” under Stark, but is with the hospital, and incentive bonuses include the group’s in-office ancillary services then the contract would violate Stark.

Also important is the issue of liability.  The hospital may set up a physician corporation, or limited liability company, to shield the hospital’s assets.  If the contract is with the hospital instead of that separate entity, the hospital’s assets are at risk.

Some other details to check are to make sure the entity on the first page is the entity listed in the signature block on the last page.  Again, having a different legal entity in the signature block does not happen that often, but it does happen and making sure the entities are the same can save much heartache.

Finally, make sure the employment contract is signed by both parties.  An unsigned employment contract could spell trouble from a Stark perspective.  For example, although the Stark employment exception does not require a written contract, if an employer wants to take advantage of certain things, such as directing referrals, the contract must be in writing and signed by the physician.

So, make sure to dot those “i”s and cross those “t”s when drafting or reviewing contracts.

September 14, 2017

Posted on by HSMAdmin

QUESTION:        We just discovered that several leases between the hospital and physicians who are active members of our medical staff expired several years ago without being renewed in writing.  We understand that the Stark Law requires a written lease.  Do we have any alternative other than a self-disclosure?

ANSWER:           Yes.  On November 16, 2015, CMS provided some much needed relief from technical violations of the Stark Law such as the one that you have described.

The first thing that you must determine is that a lack of a writing is the only problem that you have.  Therefore, you need to document that each lease complied with the other requirements of the Stark rental of office space exception, especially that at all times the rent that was paid by each physician constituted fair market value, commercially reasonable rent that did not take into account or vary based on any referrals or other business generated by the physicians.

If so, then you should be aware that in the November 16, 2015 Federal Register, CMS stated that it has received numerous submissions similar to your question that related to potential violations caused by the writing requirement, including the “…failure to renew an arrangement that expired on its own terms after at least 1 year.”  80 FR 71314.

CMS then clarified the writing requirement, provided policy guidance, and also provided illustrative examples of the writing requirement, including “checks issued for items, services or rent” (80 FR 71316).  (Emphasis added.)  In all likelihood, each month each physician paid the physician’s rent with a check that was in writing and signed by each physician, and each month the hospital endorsed and deposited those checks.  If the rent was deposited electronically, then the Uniform Electronic Transaction Act will give an electronic transfer of funds the same force and effect as a written check.

Those rent checks/electronic transfers of rent will be found to constitute “contemporaneous documents (that is, documents that are contemporaneous with the arrangement) [that] would permit a reasonable person to verify compliance with the applicable exception at the time that a referral is made” (80 FR 71315) and, as such, satisfied the writing requirement set forth in 42 C.F.R. §411.357(a).

Since this is a policy clarification and not a new regulation, the fact that the leases expired prior to the date of the CMS guidance does not prohibit you from applying this guidance to your situation, even if those expired leases predate that guidance.

If the leases expired after January 1, 2016, then you can take advantage of a change to the Stark Rental of Office Space exception that went into effect on January 1, 2016, which provides that the lease will continue to comply with the Stark exception so long as the lease continues to satisfy the other requirements of the exception.  (See 42 C.F.R. §411.357(a)(7).